Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI
Phase: NA
Conditions: Parkinson's Disease
Sponsor: VA Office of Research and Development

Official Title: Cognitive Rehabilitation for Individuals 
with Parkinson's Disease and MCI 
Date: Most Recent Version Last Approved on 1/17/2020 

Human Protocol (Version 1.33)
General Information
*Please enter the full title of your protocol:
Cognitive Rehabilitation for Individuals with Parkinson's Disease and MCI
 
 
*Please provide a short name (nickname) to reference this protocol:
CogSMART-PD-II
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Add Site(s)
VA Site (************** DO NOT ADD OR CHANGE, just save and continue **************):
Primary 
Dept?
Department Name
VASDHS - VASDHS
 
Identify protocol staff members
*Please add a Principal Investigator for the study:
 
Schiehser, Dawn M., PhD
 
3.1 Add all other VA research staff personnel (if name is not in the list, please contact Research 
Staffing to confirm appointment status)
 
A) Additional Investigators
Filoteo, J. Vincent, PhD 
 Co-Investigator
Harrington, Deborah L., PhD 
 Co-Investigator
Simmons, Alan N., PhD 
 Co-Investigator
Twamley, Elizabeth W., PhD 
 Co-Investigator
B) Research Support Staff
Almklov, Erin L., PhD 
 Research Associate
Bashor, Kaylee 
 Research Associate
N

Bayram, Ece, PhD 
 Research Associate
Cabrera Tuazon, Angelie 
 Study Coordinator
Clark, Alexandra Leigh 
 Research Associate
Das, Aishee 
 Research Associate
Holiday, Kelsey Anne, BS 
 Research Associate
Lessig, Stephanie L., MD 
 Participating Clinician
McMann, Tiana 
 Research Associate
Ton Loy, Adan F 
 Research Associate
Vannini, Maya Bina Najmi 
 Research Associate
Walsh, Michael J. 
 Research Associate
White, Beatrice M. 
 Research Associate
Whiteley, Nicole M. 
 Research Associate
*Please select the Research Contact(s)
 
Cabrera Tuazon, Angelie 
Schiehser, Dawn M., PhD 
The Research Contact(s) will receive all important system notifications along with the Principal 
Investigator. (Research Contacts are typically Study Coordinators or the Principal Investigator 
themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Dawn M. Schiehser, PhD
Protocol Title:
Cognitive Rehabilitation for Individuals with Parkinson's Disease and MCI
IRB Protocol Number:
H130022
Protocol Nickname:
CogSMART-PD-II
Form Template Version:
Date Prepared:

01/15/2020
Please be advised that this protocol application form has changed as a result of the 2018 Common Rule.  There are new 
questions and sections, and you may be required to provide additional information to previous sections.
1a) Is this study considered human research?
Yes 
No 
I don't know 
1b) Please select:
This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
Was this study initially approved prior to January 21, 2019?
 Yes   
 No
Were you instructed to convert to the 2018 Common Rule Requirements?
  Yes   
  No
 Section 2 - Research Subjects
2a) What is the total planned number of VA-consented subjects? 
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented consent, 
oral consent, or other).
350
2b) What is the total number of VA subjects who WILL NOT be consented? 
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about people 
are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients whose charts you 
will review, you still should enter the number of charts as your “planned subjects."
0
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be required. 
Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or prospective 
observational and retrospective record review studies that are minimal risk can be conducted in VA involving neonates.
  Yes   
  No
2.1b) Pregnant women
  Yes   
  No
2.1c) Individuals with cognitive/decisional impairment
 Yes   
 No

2.1d) Non-English-speaking individuals
  Yes   
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes   
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
 Yes   
 No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
  Yes   
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be required)
  Yes   
  No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
  Yes   
  No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
  Yes   
  No
 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on 
.
Save and Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change
 Yes   
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes   
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes   
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes   
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes   
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving human 
derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an international 
source.  International research does not include studies in which VA is only one of multiple participating sites where the 
overall study-wide PI is not a VA investigator.
  Yes   
  No

3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted under 
off-station activity
VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home institution under 
their institutional approval.
 Yes   
 No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or clinics) under 
participate
at other locations
VASDHS IRB approval.
 Yes   
 No
 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes   
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
 Yes   
 No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this protocol)
specimen banking
  Yes   
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
 Yes   
 No
Does this include whole genome sequencing?
  Yes   
  No
Will participants be informed of the results of any DNA testing?
  Yes   
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes   
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
 see 
data repository
IMPORTANT:
? before checking "yes")
  Yes   
  No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
 Yes   
 No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes   
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects are 
 (which may include placebo or other control) to evaluate the effects of 
prospectively assigned to one or more interventions
the interventions on biomedical or behavioral health-related outcomes.
  Yes   
  No

3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
  Yes   
  No
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
  Yes   
  No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol
3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510(k) 
Drugs
FDA
approval.
  Yes   
  No
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes   
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
  Yes   
  No
3.4d)
 medical 
 Other
devices
  Yes   
  No
 Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
  Yes   
  No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes   
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes   
  No
3.5d) Target population has psychiatric diagnosis or behavioral complaint.
 Yes   
 No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research procedures 
uses VA clinical services
concurrent with clinical care)
  Yes   
  No
3.6b) Includes procedures or drugs that will be considered part of standard care.
  Yes   
  No

3.6c) Involves 
purposes.
lab tests done for research 
  Yes   
  No
 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes   
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
  Yes   
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
  Yes   
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes   
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes   
 No
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
 Yes   
 No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
 Yes   
 No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
  Yes   
  No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes   
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes   
  No
3.9c) The PI or other study staff member has a financial interest or other
related to this study.
 real or potential conflict 
  Yes   
  No

3.9e) This study involves 
research activities (research conducted at other institutions under the authorities or 
c llaborative 
o
approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, but does not include off-
site VA research.
 Yes   
 No
 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
10 years
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 paragraph)
Dr. Dawn Schiehser and associates are conducting a research study to find out more about the 
effectiveness of a cognitive training group intervention that provides education about cognitive, physical, 
and emotional changes associated with Parkinson’s Disease and teaches strategies to improve cognitive 
skills, including attention, learning and memory, and problem-solving. The purpose of this study is to see 
how a cognitive training course (CogSMART) impacts thinking, mood, and quality of life in individuals who 
have Parkinson’s disease with cognitive impairment. A subset of individuals will also participate in a pre- 
and post-intervention cognitive task while undergoing fMRI to assess neural changes associated with 
cognitive training. Additionally, some individuals will be asked to complete an adjunct exercise program 
either using the Wii or by participating in the Odoroki program (performing physical activity to music 
using a computer system). Some individuals will also be asked to provide a saliva sample (via buccal 
swab and/or a passive drool test) for analysis of neuroinflammatory biomarkers (e.g., cortisol, CRP, 
DHEA, and alpha-amylase) pre- and post-treatment, as well as DNA.
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize those aspects that 
hypotheses
justify the use of human subjects.
Phase I: 
This study will investigate the effectiveness of a cognitive rehabilitation and psychoeducation program on 
the neuropsychological functioning of individuals with Parkinson’s Disease (PD) who have cognitive 
impairment. The study will employ the Cognitive Symptom Management and Rehabilitation Therapy 
(CogSMART), a group cognitive training intervention that provides education about cognitive, physical, 
and emotional changes associated with PD and teaches compensatory cognitive skills (attention, learning 
and memory, and problem-solving) that are affected by PD. 
Aim 1. To investigate the efficacy of a cognitive rehabilitation program, CogSMART, in a population of 
individuals with Parkinson’s disease who have cognitive impairment. 
Hypothesis 1a: Compared to wait-list controls, CogSMART participants will have improved cognitive 
functioning, functional skills and quality of life immediately following treatment. 
Hypothesis 1b: CogSMART participants will maintain their improvements at 6 months (3 months post-
treatment). 
Hypothesis 1c: CogSMART participants will maintain their improvements at 12 months (9 months post-
treatment). 
Aim 2. To investigate the vicarious effects of a cognitive rehabilitation program, CogSMART, on the 
caregivers of the participants. 
Hypothesis 2: Compared to wait-list control caregivers, caregivers of CogSMART participants will report 
increased quality of life and mood immediately following their participant’s treatment and 3- and 9-
months post-treatment. 
Exploratory Aim 1: To examine neural changes associated with the performance on an fMRI executive 

function task following participation in CogSMART. 
Exploratory Hypothesis 1: Compared to the non-intervention/waitlist PD participants, CogSMART 
completers will evidence a reduction in the dorsolateral prefrontal gyrus (due to increased cognitive 
efficiency) during an fMRI task of executive functioning. 
Exploratory Aim 2: To investigate the feasibility and efficacy of improving visual-spatial cognition by using 
the Wii as an adjunct to CogSMART. 
Exploratory Hypothesis 2: Compared to CogSMART (without Wii) completers, participants who use Wii as 
an adjunct to CogSMART (CogSMART+Wii) will demonstrate greater gains in visual spatial cognition. 
Phase II:
Aim 1. Establish the efficacy of a cognitive rehabilitation program (CogSMART-PD) to improve cognition in 
individuals with PD-MCI.
Hypothesis 1: Compared with the supportive care control group, CogSMART-PD participants will 
demonstrate greater improvements in cognition at the 10-week assessment. We will examine executive 
function (Matrix Reasoning Test) as our primary outcome, as it is the test most sensitive to the earliest 
cognitive deficits in PD, impacts other cognitive functions in PD, and is a main focus of the intervention. 
We will examine the effects of the intervention on memory, subjective cognition, and cognitive strategy 
use in secondary analyses.
Aim 2. Examine the efficacy of CogSMART-PD in reducing neuropsychiatric symptoms and improving 
quality of life/ health status in individuals with PD-MCI.
Hypothesis 2: Compared with the supportive care control group, CogSMART-PD participants will 
demonstrate greater improvement in QoL/HS, and neuropsychiatric symptoms at the 10-week 
assessment.
Aim 3. Investigate the longitudinal effects of CogSMART-PD on cognition, neuropsychiatric symptoms and 
quality of life / health status in individuals with PD-MCI.
Hypothesis 3: Compared with the supportive care control group, CogSMART-PD participants will 
demonstrate less cognitive decline, fewer neuropsychiatric symptoms, and better QoL/HS at the 6- and 
12-month follow-up assessments.
Exploratory Aim 1: To examine neural changes associated with the performance on an fMRI executive 
function task following participation in CogSMART. 
Exploratory Hypothesis 1: Compared to the non-intervention/waitlist PD participants, CogSMART 
completers will evidence a reduction in the dorsolateral prefrontal gyrus (due to increased cognitive 
efficiency) during an fMRI task of executive functioning. 
Exploratory Aim 2: To investigate the feasibility and efficacy of improving visual-spatial cognition by using 
the Wii as an adjunct to CogSMART. 
Exploratory Hypothesis 2: Compared to CogSMART (without Wii) completers, participants who use Wii as 
an adjunct to CogSMART (CogSMART+Wii) will demonstrate greater gains in visual spatial cognition. 
Exploratory Aim 3: To investigate the feasibility and efficacy of improving visual-spatial cognition and 
motor skills by participating in Odoroki (computer program performing physical activity to music) as an 
adjunct to CogSMART. 
Exploratory Hypothesis 3: Compared to CogSMART (without Odoroki) completers, participants who 
practice Odoroki as an adjunct to CogSMART (CogSMART+Odoroki) will demonstrate greater gains in 
visual spatial cognition and motor skills. 
Exploratory Aim 4: To investigate changes in neuroinflammatory biomarker (cortisol, CRP, DHEA, and 
alpha-amylase) levels pre- and post-treatment for intervention and control participants.
Exploratory Hypothesis 4: Compared to the supportive care control group, CogSMART-PD participants will 
show a reduction in in neuroinflammatory biomarker levels and this reduction will be associated with 
cognitive improvement.
Exploratory Aim 5: To investigate in the association between Brain-derived Neurotrophic Factor (BDNF) 
gene expression levels and cognitive change pre- to post- intervention. 

Exploratory Hypothesis 5: BDNF gene expression levels will be associated with greater cognitive 
improvement following the CogSMART-PD intervention compared to the control condition.
Exploratory Aim 6: Investigate mediators of CogSMART-PD treatment effects.
 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
Phase I
Cognitive impairment is commonly seen in individuals with PD and includes those with mild cognitive 
impairment (MCI) or dementia (2003b; Janvin et al., 2006a; Janvin et al., 2006b; Williams-Gray et al., 
2007).  It is estimated that 30-80% of individuals with PD meet criteria for dementia (Aarsland et al., 
2001; Aarsland et al., 2003b; Aarsland et al., 2005), whereas 31-42% meet criteria for MCI (Caviness et 
al., 2007; Tedrus et al., 2009).  In non-demented PD samples, estimates of MCI range from 40-53% 
(Janvin et al., 2006a; Caviness et al., 2007; Kim et al., 2009; Sollinger et al., 2009).  Cognitive deficits in 
PD are most frequently seen in the areas of attention, executive function and memory (Muslimovic et al., 
2005; Caviness et al., 2007).  Cognition in PD tends to deteriorate over time, with average annual 
decreases on the MMSE of 2.3-2.4 points in non-demented PD (Kandiah et al., 2009). In an unpublished 
study, Dr. Filoteo and colleagues found that their sample of non-demented PD patients declined from a 
mean of 139.0 to 134.2 on the Mattis Dementia Rating Scale (MDRS; Mattis, 1988), a scale of global 
cognitive functioning.  In a meta-analysis conducted by Muslimovic et al. (2007)declines in global cognitive 
function, visuoconstruction, and memory were evident in non-demented PD over a mean of 29 months. 
Dementia in PD, most commonly referred to as Parkinson’s disease dementia (PDD), is characterized 
predominantly by a progressive dysexecutive syndrome in the absence of prominent aphasia, apraxia or 
agnosia (Emre, 2003).  The conversion to dementia is greater in PD compared to normal age-matched 
controls (Aarsland et al., 2003b).  In a longitudinal study conducted over 8 years by Aarsland et al. 
(2003), 26% of individuals with PD met criteria at baseline (average duration of symptoms = 11 years), 
52% met criteria for dementia after 4 years, and 78% met criteria for dementia after 8 years.  As 
evidenced these aforementioned studies, those with PD and cognitive impairment are at high risk for 
further cognitive decline and progression to dementia.  The ability to improve cognition in those who have 
cognitive impairment and possibly slow the progression of cognitive decline would be extremely beneficial 
to individuals with PD and their caregivers.  Improvements in cognition could enable individuals with PD to 
become more independent and improve the quality of their life as well as the quality of life of their 
caregivers.
 
Most interventions for cognitive impairment in PD to date have been pharmacologic and although positive 
results have been found with cholinesterase inhibitors rivastigmine (Emre et al., 2004), galantamine 
(Aarsland et al., 2003a), and donepezil (Fabbrini et al., 2002), side effects, including increased in motor 
symptoms, have weakened enthusiasm for this method of treatment.  Cognitive rehabilitation has been 
well documented to successfully provide cognitive improvements in non-progressive conditions such as 
traumatic brain injury and stroke (Cicerone, 2005); yet only recently have cognitive rehabilitation 
techniques been explored in individuals with PD.  While the literature in this area is still limited, there is 
emerging evidence that cognitive rehabilitation techniques may be effective with a PD population.  In a 
study by Sinforiani et al. (2004), cognitive rehabilitation via computerized neuropsychological training was 
found to be effective at improving cognition in story memory, phonemic fluency, and visuospatial executive 
functioning (Raven’s matrices) in 20 early PD patients with mild cognitive deficits.  Improvements 
remained after 6 months, suggesting that cognitive rehabilitation was effective at improving cognition long-
term (Sinforiani et al., 2004).  Sammer et al. (2006)found that following executive function skills training, 
24 PD patients demonstrated improvement on similar measures of executive function compared to 
baseline.  While these studies are promising and provide data that cognitive training can be effective at 
improving measurable cognitive skills, no literature exists as to whether cognitive rehabilitation can 
improve functional capacity outside of the testing environment or quality of life of the patients or 
caregivers.  It is our desire to include these assessments to better ascertain the benefits, if they exist, to 
cognitive rehabilitation for individuals with PD and cognitive impairment.
 
Results of this study will provide essential information about non-pharmacologic (i.e., cognitive 
rehabilitation) interventions for individuals with PD and cognitive impairment that may improve cognitive 
abilities of affected individuals as well as their functional capacity, their quality of life and the quality of life 
of their caregivers.  Moreover, these results may provide the first evidence of preventing or extending 
cognitive decline over time in PD.
 
As an exploratory aim, this study will also provide information regarding the neural changes associated 
with cognitive training in PD.  To our knowledge, only one study has attempted to use fMRI to assess 
changes in brain function following cognitive training.  Nombela and colleagues (2011) compared the 
performance of 5 PD patients trained on Sodoku puzzles to 5 untrained PD patients on an fMRI executive 

function task. Trained individuals demonstrated improved executive function on the task as well as 
reduced cortical activation patterns (Nombela et al.).  The authors reported that since previous studies 
have linked cortical over-activation in PD to the depletion of neuro-transmitters, including dopamine and 
their metabolites, a reduction in 
 brain activation patterns suggest 
 in brain 
overall
improvement
functioning.  However, further study is needed to verify these findings.
 
As an additional exploratory aim, we will investigate the feasibility and efficacy of improving visual-spatial 
cognition by using the Wii as an adjunct to CogSMART.  CogSMART teaches compensatory strategies for 
many of the relevant cognitive deficits (i.e., attention, memory, executive function) observed in PD 
patients.  However, the program is limited by the lack of strategies for improving visual-spatial 
function.  Visual-spatial functions are often impaired in PD patients and can cause problems in everyday 
activities of living (e.g., driving).  Therefore, a program that can ameliorate this vital function would be 
advantageous to improving the quality of lives in these patients.  Recent evidence supports the use of the 
Wii in improving motor functions in PD patients (Mhatre et al., 2013), but it is currently unknown how 
participation in such a program may impact visual-spatial functions.  As the Wii games involve not only 
coordination of movements, but also visual-spatial function, it is plausible that Wii participation could 
improve these functions.
 
:
Phase II
In addition to cognitive deficits, individuals with PD experience neuropsychiatric symptoms, such as 
depression, anxiety, fatigue and sleep disturbance, all of which are more common in individuals with PD-
MCI compared to PD patients with normal cognition
.  Neuropsychiatric symptoms impact QoL to a 
18
greater extent than motor symptoms
 and  may interfere with cognitive functioning as well complicate 
19
traditional treatment approaches. Therefore, interventions that also target neuropsychiatric 
symptoms in PD-MCI may be the most efficacious to improve cognition and QoL.
 
Cognitive rehabilitation is a structured, non-pharmacological intervention that aims to improve, maintain, 
or delay the decline of cognitive skills with the ultimate goal of improving the ability to function in 
everyday life
. Data on the efficacy of cognitive rehabilitation in individuals with PD is tremendously 
22
limited. Based on our review of the literature (
) and a recent review paper on 
Schiehser et al., in press26
non-pharmacological interventions for cognitive impairment in PD
, only a handful of studies have 
27
evaluated cognitive rehabilitation in PD. The majority of these studies used computerized drill-training with 
the focus on one or more cognitive deficits (commonly called restorative rehabilitation).
In their recent review paper, Hindle and colleagues (2013) concluded that there was only one randomized 
controlled study with a low risk of bias
. This study, conducted by Paris et al.
, demonstrated that after 
27
31
4 weeks of comprehensive cognitive skills training (three 45-minute sessions per week),16 nondemented 
PD patients (50% PD-MCI) showed significant improvements in attention, processing speed, memory, 
visuospatial abilities, and executive function
. Despite these promising findings, this study and the 
31
majority of other related studies have been limited by small sample sizes, minimal use of control groups, 
lack of using a standard MCI diagnosis, and inadequate assessment of treatment impact on everyday 
cognition and QoL
. As a final statement, Hindle
 emphasized that “
27
27
There is an urgent need for rigorous 
randomized controlled trials of non-pharmacological, noninvasive treatments for cognitive impairment in PD
”
.
p.1048
 
There are two main approaches to cognitive rehabilitation: 1) Restorative, which focuses on re-training 
patients on specific cognitive skills lost due to trauma or disease, and 2) Compensatory, which focuses on 
teaching patients compensatory strategies to work around their cognitive deficits. While restorative 
approaches have been the type of rehabilitation most studied in PD to date, there have been no studies of 
compensatory approaches in PD.  The focus of this project will be to examine the impact of a 
compensatory cognitive rehabilitation program in PD-MCI.  Our decision to examine this approach (as 
opposed to restorative approaches or a comparison of the two) was made for several reasons.  First, past 
meta-analytic studies strongly suggest that cognitive deficits in other progressive neurocognitive disorders 
are best targeted by compensatory strategies
. Second, there currently are 
 evidenced-based 
32 p. 526
no
studies showing the efficacy of a compensatory strategy in treating cognitive deficits in PD-MCI.  Third, 
until there is strong evidence for the use of compensatory approaches to cognitive rehabilitation in PD-
MCI, it would be premature to contrast this approach with other approaches (see Huckans et al.
 for a 
33
similar argument in MCI).  Fourth, our years of experience in researching cognitive functioning in PD (e.g., 
Schiehser et al.
; Filoteo et al.
) and cognitive rehabilitation using compensatory approaches (e.
14, 34
35-37
g., Twamley et al.
) has placed our group in a very unique position to develop and provide empirical 
38, 39
evidence for a novel compensatory approach to treat cognitive impairment in PD-MCI.
 
Relevance to Veterans’ Health
PD is a progressive degenerative disorder with an estimated 80,000 current Veterans diagnosed with PD 
who receive care at the Department of Veterans Affairs (VA) .  It is projected that the number of VA 
1
patients over the age of 65 will increase, indicating that the number of Veterans with PD will be even 
larger in years to come.  Given that a large proportion of these Veteran PD patients will develop cognitive 

deficits, it is imperative to develop an empirically-validated cognitive rehabilitation program that can slow 
or even reverse cognitive decline and improve quality of life for people with PD.
 
Development of CogSMART-PD
The general framework of CogSMART-PD is predicated on the versions that were initially designed for other 
neurologically impaired groups (e.g., psychosis, traumatic brain injury [TBI]). However, as PD represents a 
progressive disorder with its own unique set of cognitive deficits and neuropsychiatric symptoms, the 
program was modified substantially and tailored for use in PD. Specifically, the program includes 
information on cognitive and non-motor symptoms most impacted in PD as well as psychoeducation 
regarding the progressive nature of cognitive deficits. Likewise, strategies to improve neuropsychiatric 
symptoms, such as sleep, fatigue, and mood are also incorporated.
 
As an exploratory aim, this study will also provide information regarding the neural changes associated 
with cognitive training in PD.  To our knowledge, only one study has attempted to use fMRI to assess 
changes in brain function following cognitive training.  Nombela and colleagues (2011) compared the 
performance of 5 PD patients trained on Sodoku puzzles to 5 untrained PD patients on an fMRI executive 
function task. Trained individuals demonstrated improved executive function on the task as well as 
reduced cortical activation patterns (Nombela et al.).  The authors reported that since previous studies 
have linked cortical over-activation in PD to the depletion of neuro-transmitters, including dopamine and 
their metabolites, a reduction in 
 brain activation patterns suggest 
 in brain 
overall
improvement
functioning.  However, further study is needed to verify these findings.
 
As an second exploratory aim, we will investigate the feasibility and efficacy of improving visual-spatial 
cognition by using the Wii and/or a program called Odoroki (a prototype system which engages the visual, 
vestibular, proprioception, motor, and auditory systems of an individual or small group of users in 
simultaneous physical and mental activity) as an adjunct to CogSMART.  CogSMART teaches compensatory 
strategies for many of the relevant cognitive deficits (i.e., attention, memory, executive function) observed 
in PD patients.  However, the program is limited by the lack of strategies for improving visual-spatial 
function.  Visual-spatial functions are often impaired in PD patients and can cause problems in everyday 
activities of living (e.g., driving).  Therefore, a program that can ameliorate this vital function would be 
advantageous to improving the quality of lives in these patients.  Recent evidence supports the use of the 
Wii in improving motor functions in PD patients (Mhatre et al., 2013), but it is currently unknown how 
participation in such a program may impact visual-spatial functions, or how participation in Odoroki can 
improve visual spatial functioning or motor symptoms..  As the Wii games and Odoroki involve not only 
coordination of movements, but also visual-spatial function, it is plausible that Wii participation and/or 
Odoroki could improve these functions.
 
As an additional exploratory aim, we will investigate salivary brain-derived neurotrophic factor (BDNF) 
and salivary cortisol levels (post-intervention compared to pre-intervention) in both groups. 
Animal and human evidence demonstrates that glucocorticoids (mainly cortisol in humans), the main class 
of stress hormones, are found in greater density in the prefrontal cortex and limbic system structures (e.
g., amygdala, ACC) (Herman et al, 2012; Lucassen et al., 2014), and are strongly linked to memory 
performance, such that elevated levels of cortisol are associated with memory decline in normal and 
pathological cognitive aging (Souza-Talarico, 2011). In PD, cortisol levels are abnormally elevated 
Charlett et al., 1998; Hartmann et al., 1997)
compared to healthy controls (
, indicating that cortisol may 
be more detrimental to cognition in this vulnerable subset of the population.  Empirical research has 
demonstrated that behavioral interventions promote cognitive function and may inhibit the production of 
Crăciun, 2015)
cortisol in the HPA axis (Holdevici and 
.  However, the interaction between cognitive 
remediation and the glucocorticoid response in PD is unclear.  It is hypothesized that cognitive 
rehabilitation (CogSMART-PD) will promote better cognitive functioning and correspond to a reduction in 
cortisol in PD-MCI. 
 
BDNF plays a critical role in synaptic plasticity and dopaminergic neural growth (Gómez-Palacio-Schjetnan 
and Escobar, 2013).  In PD, BDNF is reduced (Scalzo et al., 2010) and this reduction has been linked to 
cognitive deficits observed in this population (Kahlil et al., 2016).   A recent pilot study (n=8) supports 
BDNF as a biomarker of the effects of cognitive rehabilitation in PD (Angelucci et al., 2015).  Thus, it is 
hypothesized that BDNF gene expression levels will be associated with cognitive change following 
CogSMART-PD.
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the project.  Provide a precise 
description of the planned data collection (include what systems or databases will be used/accessed to gather data), analysis and 
interpretation.  For chart review studies, include the timeframe of collection.  Address sample size, inclusion of women and 
minorities.  Define in clear terms exactly what will be done to the human subjects. 

Phase I:
Participants:  We will recruit approximately 80 individuals who have PD and documented cognitive 
impairment and 80 caregivers from ongoing studies of neuropsychological functioning in PD (PI: 
Filoteo).  Over-recruitment by 10% will also be instituted to account for subject attrition or unusable data 
and to ensure a final sample size of 20 participants (10 x 2 CogSMART groups) for Aims 1 and 2 and 60 for 
the Exploratory Aim.  All participants will be screened and excluded if they have a history of significant 
head trauma, other neurologic or major psychiatric disorders, history of developmental learning disorder, 
substance dependence, or any contraindication to participating in the cognitive treatment. The participants’ 
diagnosis of Parkinson’s disease will be confirmed by participating neurologists and cognitive impairment (i.
e., MCI or dementia) will be confirmed via neuropsychological testing and the consensus of the 
neuropsychologist investigators (Drs. Schiehser and Filoteo).  We will also recruit any identified and 
consistent caregivers of the participants to complete several questionnaires regarding the participant’s 
quality of life and daily functioning prior to and following (immediately, 3- and 9-months) the 
intervention.  All caregivers will be asked to participate if they do not have any known memory 
impairment, dementia, or another condition which would prevent them from accurately completing the 
questionnaires.
 
Procedures: 
: Appropriate individuals will be provided information about the study and 
PD participants
study staff will contact those who agree.  After receiving detailed information about the study, those who 
wish to participate will provide informed consent prior to participating in the study.  Although participants 
will be screened for inclusion/exclusion criteria prior to study entry, if, during the course of any of the 
following assessments exclusionary information becomes available, that participant’s data will not be 
analyzed for the present study.  Those passing basic screening procedures will come to the VA to consent 
to the study.  If they consent to participate, PD participants will undergo neuropsychological baseline 
testing in the same visit.  Research assistants trained in neuropsychological testing will administered the 
neuropsychological assessments to the subjects. Their VA chart, if applicable, will not be reviewed until 
after the participant has consented to participate.  Further, all PD participants will be able to continue with 
any standard clinical care that they have been participating in or may be recommended by their doctor 
during the course of their participation in the study.  After testing, PD participants will be randomized to 
either the treatment group or a wait-list control group upon consent and prior to any assessment or 
treatment by a research assisant.  Individuals will be randomized into the treatment vs. waitlist groups by 
alternating the assignments serially per each qualifying subjects’ ID number that is assigned upon study 
entry.  In other words, subjects #s 1100, 1102, 1104, etc will be assigned to the treatment group and 
subjects 1101, 1103, 1105, etc will be assigned to the waitlist group. Those randomized to receive 
treatment will attend a group cognitive rehabilitation psychoeducation program, which will meet once per 
week for 10 weeks.  Groups will consist of 8-10 individuals and will be lead by a postdoctoral fellow and/or 
an appropriately trained individual who is blinded to the participants' neuropsychological test results.
 
Wait-list control PD participants will continue to participate in any clinical treatment-as-usual and will 
receive neuropsychological assessments on the same schedule as the intervention group, though will not 
be receiving the treatment.  At the completion of the intervention, those in the wait-list group will be 
invited to enter treatment if they choose.  Three and nine months post-intervention (i.e., 6 and12 months 
post-initiation of treatment, respectively) participants will be tested again to determine maintenance of 
any cognitive gains and delay of cognitive decline.
 
 
Baseline (0 months)
0-3 months
3 
months
3-6 months
6 
months
12 
months
CogSMART
group
(N=8-10)
Consent and Assessment 
1 + Home Visit
CogSMART 
intervention
Assessm
ent 2
No CogSMART 
intervention
Assessm
ent 3
Assessm
ent 4
Wait-list 
group
(N=8-10)
Consent and Assessment 
1 + Home Visit
No CogSMART 
intervention
Assessm
ent 2
CogSMART 
intervention (if 
desired)
Assessm
ent 3
Assessm
ent 4
 
The intervention is the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART), a 
manualized group course, predicated on a compensatory approach to cognitive difficulties where 
participants learn strategies to help accommodate for any cognitive weaknesses.  This is a 
psychoeducation program, not a therapy intervention.  A trained clinician(s) leads the program one time 
per week and each session is approximately 2 hours long.  Given that this is a manualized 
psychoeducation program, individuals with a Bachelor’s degree with training and supervision, are 
appropriate to lead the group class. Groups will be lead by a postdoctoral fellow and/or an appropriately 
trained individual who is blinded to the participants neuropsychological test results. During the first hour, 
psychoeducation and techniques are provided in a specific cognitive domain, and during the second hour, 
the skills are practiced and individualized to each participant’s own situation.  In this way, the intervention 
can be conducted in groups, allowing for participants to share strategies with each other, but the content 
can be individually tailored.  The skills taught during the program are then generalizable to each patient’s 
unique situation.  The four targeted cognitive domains (see table below) were chosen for their relevance to 
everyday functioning skills and because they have been shown to be modifiable.  The program will focus 

1.  
2.  
3.  
1.  
2.  
1.  
2.  
1.  
2.  
3.  
4.  
on: education regarding cognitive and motor changes with PD, 
, 
prospective memory attention and 
, 
.  The program is further 
concentration learning and memory, and problem-solving and cognitive flexibility
detailed in the table below:
 
Targeted Domain
Examples of Importance 
of Domain at Work
/School or for 
Independent Living
Specific Compensatory Strategies and Habits in 
CogSMART Cognitive Training
Prospective Memory
Remembering to go 
to appointments
Remembering to 
take medications
Remembering to 
send in bills or 
requested paperwork
Remembering to do 
tasks/chores in 
response to cues
Daily calendar use
To-do lists and prioritizing tasks
Linking tasks or using “can’t miss reminders” to 
remember tasks
Attention and
Concentration
Paying attention to 
communications 
from family and 
friends
Maintaining focus 
during medical 
appointments
Maintaining 
attention to tasks or 
household projects 
without getting 
distracted
Conversational vigilance skills (reduce 
distractions, eye contact, paraphrasing, and 
asking questions)
Task vigilance skills (paraphrase instructions, 
use self-talk during tasks to maintain focus)
Learning and 
Memory
Learning and 
remembering tasks
Learning novel 
information in 
books, community 
lectures, or 
programs.
Learning and 
remembering names 
of new people
Encoding strategies (write things down, 
paraphrasing/repetition, association, chunking, 
categorizing, acronyms, rhymes, visual imagery, 
name-learning strategies)
Retrieval strategies (systematic searching) and 
organizational strategies for general learning 
and memory
Executive 
Functioning 
(Problem Solving 
and Cognitive 
Flexibility)
Problem solving and 
coping with 
unexpected 
situations
Thinking flexibly and 
self-monitoring 
performance on 
daily activities
6-step problem solving method (define problem, 
brainstorm solutions, evaluate solutions 
systematically, select a solution, try it, evaluate 
how it worked)
Self-talk while solving problems
Hypothesis testing
Self-monitoring
 
Previous work with this intervention in a psychiatric population has been well received by participants, and 
demonstrated medium effect sizes for verbal memory, learning and executive functioning, a large effect 
size for attention/concentration, and a medium effect on self-reported cognitive problems (Twamley et al., 
2008).  Many of these gains were maintained at three months post-intervention.
 
Caregivers: If the participant has an identified consistent caregiver (e.g., spouse), this individual will be 
asked to complete several questionnaires related to their assessment of the patient’s functioning at the 
time of the participants baseline assessment and again immediately following the intervention, and at 3- 
and 9-months post-intervention. The caregivers to the participants will be invited to attend the CogSMART 
class solely as observers. They will not be allowed to participate, but they will be able to sit in to have a 
better understanding of what the patient is learning.
 

    Assessments:  To document changes over time in both the intervention and wait-list groups, all 
participants will undergo neuropsychological assessment at baseline (pre-treatment), after the three 
month intervention period, six-months after baseline (three months from the end of the intervention), and 
12 months after baseline (nine months from the end of the intervention) to determine persistence of 
results.  The baseline assessment will entail a comprehensive neuropsychological exam consisting of 
measures of global cognitive functioning [Mattis Dementia Rating Scale (MDRS; Mattis, 1988), memory 
[California Verbal Learning Test (CVLT-II; Delis et al., 2000); Visual Reproduction Test (VRT) from the Wec
 Scale-
 (Wechsler, 2008a)], attention/concentration (Digit Span and Digit 
hsler Memory
Fourth Edition
Symbol Coding from the 
 (Wechsler, 2008b)], language [Wide Range 
Wechsler Adult Intelligence Scale-IV
Achievement Test- Reading (WRAT-4; Wilkinson, 1993)], visuospatial skills [Judgment of Line Orientation 
Test (Benton et al., 1983)], executive functioning [Wisconsin Card Sorting Test-64 (WCST-64; Kongs et 
al., 2000); Verbal Fluency Test and Color-Word Interference Test from the Delis Kaplan Executive 
Functioning System (DKEFS; Delis et al., 2001); Matrix Reasoning from the WAIS-IV], mood/anxiety 
[Hamilton Rating Scale for Depression 17-Item (HAMD-17; Hamilton, 1960); Geriatric Depression Scale 
(GDS; Yesavage e
t al., 1982); Neuropsychiatric Inventory 14-Item version (NPI; Cummings et al., 1994); State Trait 
Anxiety Inventory (STAI; Spielberger et al., 1983)], functional skills [Unified Parkinson’s Disease Rating 
Scale (UPDRS; Fahn, 1987); The Physical and Instrumental scales of the Activities of Daily living 
Questionnaire (IADL; Lawton and Brody, 1969)], and quality of life [Parkinson’s Disease Questionnaire-39 
(PDQ-39; Peto et al., 1995)]. Motor functioning will be assessed by a neurologist using the UPDRS-Part 3. 
The entire pre-treatment cognitive/motor assessment will take approximately three hours to complete.  If 
participants have recently been tested clinically or as part of participation in an existing cognitive aging 
study, this data may be used for the baseline assessment, to reduce any unnecessary burden to the 
participant.  In addition, all participants who consent and agree will undergo a 30-minute home evaluation. 
This evaluation will assess impediments to ideal cognitive and motoric functioning (e.g., organization of 
home) and offer strategies to improve motoric and cognitive function (e.g., use of mats/runners through 
doorways for cues to prevent freezing). If the participant has an identified consistent caregiver (e.g., 
spouse), this individual will be asked to complete several questionnaires related to their assessment of the 
patient’s functioning (Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE; Jorm and 
Jacomb, 1989); The Physical and Instrumental scales of the Activities of Daily living Questionnaire (IADL; 
Lawton and Brody, 1969), NPI – informant version) and quality of life (PDQ-39 proxy form), their ratings 
of their own level of burden regarding caregiving [Caregiver Burden Inventory; (CBI; Novak and Guest, 
1989)], and their self-reported mood [HAMD-17, GDS; and STAI]. The caregiver questionnaires are 
estimated to take approximately 30-40 minutes to complete.
 
     At post-treatment and 6-month (3 months post-intervention) follow-up, participants will be 
administered the Mattis Dementia Rating Scale (MDRS; Mattis, 1988), California Verbal Learning Test – II 
(CVLT-II; Delis et al., 2000), Digit Span and Digit Symbol Coding from the WAIS-IV (Wechsler, 2003), 
Verbal Fluency and the Color-Word Interference tests from the Delis Kaplan Executive Functioning System 
(Delis et al., 2001), Matrix Reasoning from the WAIS-IV, the Geriatric Depression Scale (Yesavage et al., 
1982), Hamilton Rating Scale for Depression 17-Item (HAMD-17; Hamilton, 1960), Neuropsychiatric 
Inventory 14-Item version (NPI; Cummings et al., 1994); State Trait Anxiety Inventory (STAI; Spielberger 
et al., 1983), The Physical and Instrumental scales of the Activities of Daily living Questionnaire (IADL; 
Lawton and Brody, 1969), and the Parkinson’s Disease Questionnaire-39 (PDQ-39; Peto et al., 
1995).  These follow-up assessments will take approximately 2 hours to complete.  Caregivers will be 
asked to complete the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE; Jorm and 
Jacomb, 1989), the PADL and IADL scales – informant version, the PDQ-39 proxy form, the Caregiver 
Burden Inventory (CBI; Novak and Guest, 1989), and the Hamilton Rating Scale for Depression 17-Item 
(HAMD-17; Hamilton, 1960), Geriatric Depression Scale (GDS; Yesavage et al., 1982), and the State Trait 
Anxiety Inventory (STAI; Spielberger et al., 1983). We will use counterbalanced alternate forms of the 
tests included in the neuropsychological assessment, when available, to partially address practice 
effects.  At 12 months (9 months post-intervention), participants will be given the entirety of the battery 
they completed at baseline. Standardized alternative forms that measure the same or similar cognitive 
abilities may be substituted for the aforementioned tests if warranted to prevent practice effects, fatigue, 
or participant attrition.
 
All data will have quality control measures applied.  All neuropsychological assessments will be double-
scored to ensure accuracy.  Data will be compiled in a database and all data will be double entered to 
preserve the integrity of the database.  The subjects' confidentiality will be strictly maintained in data 
storage, analysis, and presentation.
 
Our projected sample size is consistent with the sample reported on in the preliminary data section 
(Twamley et al., 2008).  As we propose to use a similar sample size and the same cognitive rehabilitation 
program, we anticipate achieving similar medium to large effect sizes in the proposed study.  To determine 
whether CogSMART will improve cognition in PD, we will employ statistical analyses including reliable 
change indexes to take into account change in neuropsychological test scores over the course of the 
intervention while also accounting for predicted practice effects.  We will compare the treatment and 
control groups on baseline and three-month change scores.  Group comparisons of differences and 

changes in neuropsychological test scores between as well as within groups will also be determined via 
repeated measures (RM) ANCOVAs.  Cognitive, functional, and quality of life indices of both participants 
and caregivers will be of interest in determining efficacy of treatment.
 
As an exploratory aim, we will recruit 60 additional individuals to complete the protocol as described above 
and in addition, participate in two (pre/post) hour-long brain imaging (fMRI) sessions.  The imaging 
sessions will consist of a structural brain scanning and participation in an fMRI cognitive task (please see 
below).  Following the baseline evaluation, half of the participants will be randomly assigned to the 
intervention group (
= 30) and participate in the CogSMART program.  The groups will be broken up to 
n 
consist of 8-10 individuals.  The remaining participants (
= 30) will be assigned to the non-intervention
n 
/waitlist (“care-as-usual”) group.  This group will also be broken down into groups of 8-10 when enrolled in 
the intervention.  Participants will be retested by a group assignment-blinded examiner on the clinical and 
cognitive battery and imaging protocol following the intervention or waitlist.
 
fMRI task and analysis: Participants will undergo fMRI while performing the Matrix Reasoning task (f-MRT), 
a well-developed and normed test of executive functioning for fMRI (Allen & Fong, 2008). Within the 
scanner, participants will be presented with 4 practice items followed by 24 test stimulus items and 24 
alternative stimuli, conceptually modeled after problems found on the Raven’s Progressive Matrices test, as 
well as items from the matrix reasoning subtest of the WAIS-III, collectively called the f-MRT (Allen and 
Fong, 2008). Each stimulus consists of a 3 
3 matrix of complex visual figures, with one figure missing. 
× 
For each matrix problem, participants will be instructed to “indicate what the missing figure should be,” 
and to then select it from among the four choice alternatives presented on the right side of the 
matrix.  Participants will also be told to place more importance on response accuracy than on response 
speed. Accuracy (% correct) and reaction time will be measured.
 
Each participant’s scanning session will last approximately one hour, during which an anatomical scan and 
two functional scans will be run while performing the tasks. An 8-channel brain array coil during a series of 
T2* weighted EPI scans acquired to measure BOLD functional activity will be used. The parameters for the 
EPI scans will be: 64x64 matrix, 3.43 x 3.43 x 2.6 mm voxels with 1.4 mm gap, TR = 2 seconds, TE = 32 
ms, flip angle of 90 degrees, and 30 slices. These parameters will cover the entire brain. The acquisition of 
the EPI scans will be performed in the axial plane. Tasks are synchronized with the scanner using a TTL 
pulse sent to a laptop computer.
 
As secondary exploratory aim, we will recruit 8-10 additional individuals to participate in 30-minutes of Wii 
training (tennis, golf, and ping pong games) in addition to the CogSMART program.  These individuals will 
be assessed with the same procedures as described for the CogSMART (without Wii) participants.
 
All procedures are performed for research purposes.
 
Phase II:
Participants:  110 patients (55 per group) with PD-MCI will be recruited for this study as well as 110 
identified and consistent caregivers of the participants. All caregivers will be asked to complete several 
questionnaires regarding the participant's quality of life and daily functioning prior to the intervention, at 
follow-up visits, and after the intervention. Although attrition did not occur in Phase I, over-recruitment by 
20% will be instituted to account for possible subject attrition or unusable data. Participants will receive a 
payment of $40 for each of the four assessments they complete (pre- and post-intervention/support and 
6- and 12-month follow-ups).
 
Procedures: We will primarily recruit Veterans with PD from the VASDHS Neurology and Neuropsychology 
Clinics.  While we will attempt to exhaust recruitment at VA clinics first, recruitment of women may be 
limited at the VA, and therefore, we will likely need to recruit from outside clinics to obtain a PD-
epidemiologically accurate gender ratio of 60 (men)/40 (women). In this regard, we will primarily recruit 
from the University of California, San Diego (UCSD) Movement Disorders Center. Referred participants will 
be screened for inclusion/exclusion criteria (please see above) and consented if appropriate. All 
participants will have Level II MDS-criteria based diagnosis of MCI derived from a formal 
neuropsychological evaluation within the past 12 months.  As most participants will be referred from the 
VASDHS and UCSD Movement Disorder Center, the majority will have MDS-criteria MCI diagnoses prior to 
referral.  However, should a PD patient be referred for this study who has not had formal 
neuropsychological testing or if testing is outdated (>12 months), pre-inclusion neuropsychological testing 
will be performed through Dr. Filoteo’s lab, which follows patients neuropsychologically.  Likewise, if the 
WRAT-4 Reading scale has not been administered within the past year, this 2-5 minute measure will also 
be administered to ensure adequate reading level. To avoid confounds, 
 test proposed as outcome 
no
measures in this study will be used to determine the PD-MCI diagnosis.
 
Upon meeting study criteria, participants will be randomized to one of two 10-week conditions (CogSMART-
PD or Supportive Care). Randomization will occur in blocks (i.e., first 5 people enrolled will be assigned to 
the intervention group, next 5 will be assigned to control group, next 5 will be assigned to the intervention 
group, and so on until the sample size of 55 per group is met).  Within one to 1.5 weeks prior to beginning 
the group, participants will be tested by a research assistant blinded to group assignment on a 2-2.5 hour 

battery of cognitive, neuropsychiatric, health status/QoL, and strategy use measures as well as a motor 
assessment (UPDRS-Part III), which will immediately precede the cognitive assessment (please see 
Assessment/Materials). Participants will be tested in the “on-state” of parkinsonian medications to limit 
confounding variability (e.g., of motor symptoms, such as tremor) on test results. All participants will be 
tested at the same time, preferably in the morning, if possible. Breaks will be given during the assessment 
as needed. Groups will consist of 5 individuals with PD-MCI and be led by a trained clinician (who is not 
involved in the clinical care or assessment of these participants).  Following the intervention and 6- and 12-
months post-intervention, PD-MCI participants will be re-tested by a group-blinded research assistant.  24 
months post-intervention, participants will be asked to complete a brief (15 minute) telephone interview 
regarding changes in health status or living situation since the 12-month follow up. Following the 12-
month follow-up, the control (support) group will be permitted to join CogSMART-PD. 
 
Assessment/Materials: Outcome measures were carefully selected so that they: 1) represent areas that 
are frequently impaired, dysfunctional, or problematic for individuals with PD-MCI; 2) correspond to 
domains that are targeted for improvement by the CogSMART-PD intervention; 3) have adequate 
psychometric properties for use in PD; and 4) have shown utility and applicability based on the pilot and 
preliminary studies.  Total neuropsychological and motor testing time is estimated to be 
.
2-2.5 hours
 
Cognitive Function and Cognitive Strategy Assessment:
1. 
 from the Wechsler Adult Intelligence Scale-IV [WAIS-IV] is a 15-minute 
Matrix Reasoning subtest (MRT)
valid, reliable, and widely-used standardized neuropsychological test that is considered one of the gold 
standards of 
. The MRT is commonly used to assess executive function in individuals 
executive function28
with PD, as it does rely on motor function.
2. 
.  The MIST is an 8-trial and 30-minute performance-
Memory for Intentions Screening Test (MIST)62
based 
 test with a minimal motor component. Scores range from 0 to 48, with higher 
prospective memory
scores representing better performance.  The MIST entails participants performing prospective memory-
based tasks based on time cues (e.g., “In 15 minutes, tell me that it is time to take a break”) or event 
cues (e.g., “When I show you a post card, self-address it”) while performing word search puzzles 
(distracter task).  There are four trials each of the time and event cues, with each item scored from 0-2 
points; thus, the separate event-based and time-based scales have scores ranging from 0 to 8. The time- 
and event-based trials are balanced for delay interval (i.e., 2- and 15-min delay periods) and response 
modality (i.e., verbal and action responses).  The “event cues” task score is considered particularly 
ecologically relevant, in the required response is related to the actual task (e.g., “When I hand you a 
request for records form, please write your doctors’ names on it.”) and therefore, represents natural cuing 
that is often encountered in everyday life 
.  Thus, this measure will be the primary variable studied in 
63
this study. Other indices (e.g., summary score and time-based score) will be explored as well.  The MIST 
has been studied in PD
 and studies support its adequate reliability and construct validity
.
63, 64
43, 65
3. 
 is a 10-minute valid, reliable, standardized 
Memory Assessment Scales (MAS) Names-Faces subtest
neuropsychological test of 
, which has been characterized as “a 
verbal (name)-visual (face) memory42
more ecologically valid memory test than the other laboratory analogues of everyday memory functions”66,
. Moreover, face-name memory is a common concern of individuals with PD and is directly relevant to 
p.356
the intervention (i.e., name learning strategy), as well as not reliant on motor functioning, thus suitable 
for PD.
4. 
. The IQCODE is a 26-item, 5-
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)39
minute informant-based questionnaire used to assess the patient’s everyday functional-based measure of 
 (e.g., recognizing familiar faces, remember things in general, handling financial matters) on a 5-
cognition
point scale (1=much improved to 5=much worse).  The IQCODE has been used fairly extensively in 
individuals with cognitive impairment and has been found to have high reliability and good validity
. In 
52
addition, we will also administer the self-report version the IQCODE (IQCODE-SR) to the patients. A 
psychometric study of the IQCODE-SR found it to have good feasibility, homogeneity, and construct validity
. The IQCODE has been used as an outcome in several seminal PD studies (e.g., Aarsland et al., 2009
).
67
68
We conducted a validation study (manuscript in preparation), of the IQCODE in 100 PD patients and found 
it to have adequate convergent validity with a clinician-measure of cognition (UPDRS Item 1; r = .39, p < .
001) and excellent discriminant validity from measures of motor symptoms (UPDRS-Part III Total; r = .08, 
p = .41) and disease severity (Hoehn and Yahr; r = .11, p = .26).
5. The 
 will be administered at the baseline (pre-intervention) 
Montreal Cognitive Assessment (MoCA)
assessment as a measure of 
 and will be used as a covariate in the statistical analyses 
general cognition
(please see Data Analysis section below). The MoCA is a suitably accurate, brief (10-minute) test of 
cognitive impairment in PD and has established cut-offs for both PD-MCI and PDD.69
6. 
.  The Strategies Assessment section of the 
Cognitive Problems and Strategies Assessment (CPSA)38
CPSA will be used as an assessment of 
 used by the individual.  This questionnaire 
compensatory strategies
was found to be sensitive to the use of cognitive strategies after cognitive rehabilitation (CogSMART) 
participation
.  The CPSA takes 8-10 minutes to complete.
38
7.
 This is a cognitive 
 Parkinson's disease Cognitive Rating Scale (PD-CRS; Pagonabarraga et al., 2008).
scale specifically designed for individuals with Parkinson's disease. The assessment has a total of 9 tasks 
meant to assess attention, working memory, alternating and action verbal fluency, clock drawing, and 
verbal memory and takes approximately 15 minutes to administer. 

 
Quality of Life, Health Status, and Neuropsychiatric Symptom Assessment:
1. 
. The WHOLQOL-BREF is a 26-item, 5-
World Health Organization Quality of Life-BREF (WHOQOL-BREF
)
45
10 minute measure of general 
 (i.e., an individual's perception of their position in life
), which 
QoL
57
contains 4 subscales (physical, psychological, social, and environmental) and has been recommended
 
70
and “suggested” for use in the PD by a 2011 MDS Task Force
. The MDS did not give it is highest rating 
71
only due to limited evidence in PD. Yet, additional validation studies of the WHOQoL-BREF in PD have been 
published since the MDS report, indicating that the WHOQoL-BREF has excellent internal consistency 
(Cronbach’s alpha = 0.91) and adequate to excellent convergent and discriminant validity in PD72, 73
2. 
. The PDQ-39 is a self-report measure of 
Parkinson’s Disease Questionnaire-39 (PDQ-39)44
health status 
), which is considered different than QoL, in that it does not ask for perceptions, judgments or reactions
(HS
. For example, while the WHOQOL-BREF asks, “how 
 are you with your ability to perform daily 
71
satisfied
living activities?”, the PDQ-39 asks, “how 
 do you have difficulty with [daily living activities]?”. The 
often
PDQ-39 has been well-validated in PD
 and is recommended for use by the MDS.
44
3. 
. The NPI-Q is a 12-item, 5-10 minute, clinician-
Neuropsychiatric Inventory 12-Item version (NPI-Q)53
administered questionnaire that assesses various 
 (e.g., depression, anxiety, 
neuropsychiatric symptoms
apathy, and sleep disturbance). Psychiatric symptoms are identified using structured screening questions 
and positive responses are probed with structured follow-up questions.  Follow-up questions are rated in 
terms of frequency on a scale of 1 to 4 and severity on a scale of 1 to 3.  A composite score for each item 
is then devised based on the product of the frequency and severity for each item, thus resulting in a range 
of 1 to 12 for each item and a maximum score of 120, with higher scores indicating greater frequency
/severity of psychiatric symptoms.  The NPI-Q has been used successfully in previous work to characterize 
psychiatric symptoms in both demented and nondemented PD patients
.
74
 
PD Motor and Disease Severity Assessment:
The 
and the modified 
Unified Parkinson’s disease Rating Scale - Part III (UPDRS-Part III)75, 76 
Hoehn and 
 will be used to assess level of 
 and 
. For 
Yahr Rating Scale (HYRS)77, 78
motor impairment
disease severity
this assessment participants go through a series of tasks designed to assess various motor characteristics 
such as speech, facial expression, rigidity, finger tapping, hand movements, toe tapping, freezing of gait, 
balance, etc. We will also use UPDRS item #13 to assess fall risk (please see Monitoring Plan below). 
These are standard instruments for measuring the motor symptoms and disease severity in patients with 
PD and have been used extensively in both research and clinical settings.  VASDHS/UCSD neurologists will 
perform these assessments immediately prior to the cognitive assessment at the pre and 12-month follow 
up evaluations.
 
Adjunct Performance Measures: 
Motor Skill Fitness measures will be carried out by a trained research assistant at the VA Medical Center
Subjects will undergo body mass index analysis at the VA Medical Center 
De-identified data from these Motor Skill Fitness measures will be analyzed in the Smart Lab at UC San 
Diego. No participant data will be collected there.
 
Client Satisfaction with the intervention will be assessed at the end of the intervention with the Client 
. The CSQ-8 is an 8-item, 2-3 minute measure that yields a single 
Satisfaction Questionnaire (CSQ-8)79
score, ranging from 8 to 32 (each item rated on a 4-point Likert scale), with higher scores indicating 
greater satisfaction.  The CSQ-8 has been widely used in clinical research trials and is reported to have 
excellent reliability and internal consistency, acceptability to clients and service providers, and sensitivity 
to different levels of program quality.
 
Intervention: The treatment intervention is CogSMART-PD. Participants will meet in groups of 5 
individuals per group for 1.5 hours once per week for 10 weeks.
Control Group: The supportive care (control) group will entail having groups of 5 individuals with PD-MCI 
meet for peer-support for 1.5 hours once per week for 10 weeks.  A trained clinician will serve as the 
facilitator of this group and will be instructed to 
 provide any treatment or intervention strategies.  The 
not
main role of the facilitator will be to create a safe and respectful environment where members feel 
comfortable sharing their knowledge and insight with each other.
 
Monitoring Plan. As individuals with PD are at high risk for falls, we will carefully screen all individuals for 
history of falls upon recruitment. We will use the baseline UPDRS falling item (#13) in which a history of 
falls is categorized on a likert scale from 0 (none) to 4 (falls >once per day). A history of falls as assessed 
by the UPDRS appears to be one of the best predictive methods of subsequent falls at this time
. Those 
80
individuals who endorse a history of falling or score >0 on the UPDRS falling item, will be closely 
monitored. This includes ensuring that they are escorted to and from the intervention room from their 
vehicle as well as to and from the bathroom, as needed. Should a patient need help within the bathroom, 

a caregiver will be requested to assist. If needed, we will utilize the VA escort service. Although not 
common in PD, all participants will also be assessed for suicidal ideation/intent at baseline, as standard of 
care for psychological/behavioural interventions. If suicidal ideation is acknowledged, indicated by a score 
of 2 or greater on item 9 of the Beck Depression Inventory-II (BDI-II), research participants will 
be  referred directly to a VA-privileged clinician for further evaluation. These participants will be monitored 
for changes in mood during the intervention. 
 
Data Analysis: Preliminary analyses will begin with an examination of the distribution of variables to 
assess their characteristics (means, standard deviations, skewness), to provide descriptive statistics of the 
study population, and to allow assessment of randomization.  Continuous measures will be tested for 
normality and homogeneity of variance.  Non-normally distributed variables will be transformed to meet 
the normal distribution assumption for linear effects models.  Analyses will include tests of randomization 
and comparability across conditions.  Randomization will be tested by performing a series of t-tests and 
chi-square tests to compare the groups on demographic and initial clinical variables. Pre-specified baseline 
variables including age, education, gender, severity and duration of illness, and motor symptoms will be 
considered as potential covariates (as fixed effects) in the multivariate analyses. Any other variables (e.g., 
baseline cognition as assessed by the MoCA, medications) on which the groups differ initially will also be 
explored as covariates in subsequent analyses, as described below.  In the case of missing data, 
appropriate data analytic techniques will be used, which may include deletion, imputation, inclusion of an 
indicator of missing values, or pattern-mixture modeling. Outcomes will be analyzed using SPSS release 16 
(SPSS, 2007), and open source statistical software R
.
81
 
As an exploratory aim, we will recruit 60 additional individuals to complete the protocol as described above 
and in addition, participate in two (pre/post) hour-long brain imaging (fMRI) sessions.  The imaging 
sessions will consist of a structural brain scanning and participation in an fMRI cognitive task (please see 
below).  Following the baseline evaluation, half of the participants will be randomly assigned to the 
intervention group (
= 30) and participate in the CogSMART program.  The groups will be broken up to 
n 
consist of approximately 5 individuals.  The remaining participants (
= 30) will be assigned to the non-
n 
intervention/control (“supportive care”) group.  This group will also be broken down into groups of 5 when 
enrolled in the intervention.  Participants will be retested by a group assignment-blinded examiner on the 
clinical and cognitive battery and imaging protocol following the intervention or waitlist.
 
fMRI task and analysis: Participants will undergo fMRI while performing the Matrix Reasoning task (f-MRT), 
a well-developed and normed test of executive functioning for fMRI (Allen & Fong, 2008). Within the 
scanner, participants will be presented with 4 practice items followed by 24 test stimulus items and 24 
alternative stimuli, conceptually modeled after problems found on the Raven’s Progressive Matrices test, as 
well as items from the matrix reasoning subtest of the WAIS-III, collectively called the f-MRT (Allen and 
Fong, 2008). Each stimulus consists of a 3 
3 matrix of complex visual figures, with one figure missing. 
× 
For each matrix problem, participants will be instructed to “indicate what the missing figure should be,” 
and to then select it from among the four choice alternatives presented on the right side of the 
matrix.  Participants will also be told to place more importance on response accuracy than on response 
speed. Accuracy (% correct) and reaction time will be measured.
 
Each participant’s scanning session will last approximately one hour, during which an anatomical scan and 
two functional scans will be run while performing the tasks. An 8-channel brain array coil during a series of 
T2* weighted EPI scans acquired to measure BOLD functional activity will be used. The parameters for the 
EPI scans will be: 64x64 matrix, 3.43 x 3.43 x 2.6 mm voxels with 1.4 mm gap, TR = 2 seconds, TE = 32 
ms, flip angle of 90 degrees, and 30 slices. These parameters will cover the entire brain. The acquisition of 
the EPI scans will be performed in the axial plane. Tasks are synchronized with the scanner using a TTL 
pulse sent to a laptop computer.
 
As secondary exploratory aim, we will recruit 8-10 additional individuals to participate in 10, 30-minutes of 
Wii training (tennis, golf, and ping pong games) in addition to the CogSMART program.  These individuals 
will be assessed with the same procedures as described for the CogSMART (without Wii) participants.
 
As an additional exploratory aim, we will recruit 8-10 individuals to participate in 20, 1 hour-long Odoroki 
sessions where the individuals will perform physical activities to music by using a computer program. 
These individuals will be assessed with the same procedures as described for the CogSMART participants 
without an adjunct exercise program.
 
As a final exploratory aim, we will recruit 8-10 individuals to complete saliva sample collections (pre- and 
post-intervention) for salivary analysis of neuroinflammatory biomarkers (e.g., cortisol) before and after 
treatment. 
 
All procedures are done for research purposes. 
 Section 9.6 Specimens

9.6) Identify the biological materials, procedures for obtaining material, and the sources of the specimens.  Effective 12/01
/2019:  Specify whether research or clinical staff (from which service) will be collecting the specimens and describe "hand-off" 
procedures to ensure that release of the specimens has been authorized by Pathology and Laboratory Medicine Service (PALMS).
    
Pre- Intervention Buccal Swab:
Participants will be given 3 oral swab collection kits at their pre-assessment. On the day before the first 
session, participants will swab their own cheek at home once before going to bed, once upon waking in 
the morning, and once 30 minutes after waking. Participants will bring kits back on the first day of group.
Post- Intervention Buccal Swab:
Participants will be give 3 oral swab collection kits on the last session. After the last session, participants 
will swab their own cheek at home once before going to bed, once upon waking in the morning, and once 
30 minutes after waking. Participants will bring kits back to their post-assessment. 
Pre and Post- Intervention Passive Drool Test:
Participants will be asked to split or drool into a tube which has a funnel on top. If participants experience 
difficulty producing saliva, suggestions for improving saliva generation will be made. 
Samples will be stored at and analyzed by the UCSD Integrative Health and Mind-Body Biomarker 
Laboratory. Samples will be labeled with subject ID numbers and will not have identifiable information (i.
e., name, SSN, or date of birth) on the labels; the de-identified sample will be walked over to the UCSD 
Integrative Health and Mind-Body Biomarker Laboratory in a locked briefcase by study personnel. 
Samples will be destroyed after analysis.
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and attach a copy of 
the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references must be uploaded.  Reference the help 
link for additional information related to surveys administered to VA personnel and approved platforms for web-based surveys. 
Geriatric Depression Scale 
Yesavage, J. A., Brink, T. L., Rose, T. L., Lum, O., Huang, V., Adey, M., et al. (1982). Development and 
validation of a geriatric depression screening scale: A preliminary report. J Psychiatr Res, 17(1), 37-49. 
Beck Depression Inventory (BDI-II) 
Beck, A., Steer, R., &Brown, G. (1996). Manual for the BDI-II. 
State/Trait 
Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., &Jacobs, G. A. (1983). Manual for the State-
Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press. 
The Parkinson’s Disease Questionnaire 
C. Jenkinson, R. Fitzpatrick, V. Peto, R. Greenhall, and N. Hyman, “The Parkinson's disease questionnaire 
(PDQ-39): development and validation of a Parkinson's disease summary index score,” Age and Ageing, 
vol. 26, no. 5, pp. 353–357, 1997. 
Parkinson’s Disease Sleep Scale 
Chaudhuri KR, Pal S, DiMarco A, et al. The Parkinson’s disease sleep scale: a new instrument for 
assessing sleep and nocturnal disability in Parkinson’s disease. J Neurol Neurosurg Psychiatry. 2002;73(6):
629–635. 
Modified Fatigue Impact Scale 
Fisk, John D., et al. "Measuring the functional impact of fatigue: initial validation of the fatigue impact 
scale." Clinical Infectious Diseases 18.Supplement 1 (1994): S79-S83. 
Frontal Systems Behavior Scale 
Malloy, Paul, et al. "The Frontal Systems Behavior Scale discriminates frontotemporal dementia from 
Alzheimer’s disease." Alzheimer's and Dementia 3.3 (2007): 200-203. 
Informant Questionnaire on Cognitive Decline in the Elderly 
A. F. Jorm and P. A. Jacomb (1989). The Informant Questionnaire on Cognitive Decline in the Elderly 
(IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychological Medicine, 19, 
pp 1015-1022. 
Activities of Daily Living 

Lawton, M.P., &Brody, E.M. (1969). Assessment of older people: Self-maintaining and instrumental 
activities of daily living. The Gerontologist , 9 (3), 179-186. 
Caregiver Burden Scale 
Elmstahl, S., Malmberg, B., &Annerstedt, L. (1996). Caregiver's burden of patients 3 years after stroke 
assessed by a novel caregiver burden scale. Archives of physical medicine and rehabilitation, 77(2), 177-
182. 
Short Form-12 Health Survey 
Gandek, Barbara, et al. "Cross-validation of item selection and scoring for the SF-12 Health Survey in nine 
countries: results from the IQOLA Project. International Quality of Life Assessment." Journal of clinical 
epidemiology 51.11 (1998). 
The WHOQOL Group, Development of the World Health Organization WHOQOL-BREF quality of life 
assessment. Psychol Med, 1998. 28(3)(3): p. 551-8.
Neuropsychiatric Inventory 12-Item version (NPI-Q)
Kaufer, D.I., J.L. Cummings, P. Ketchel, V. Smith, A. MacMillan, T. Shelley, O.L. Lopez, and S.T. DeKosky, 
Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin 
Neurosci, 2000. 12(2): p. 233-9.
14-item Modified Falls Efficacy Scale (MFES) 
Hill, K. D., Schwarz, J. A., Kalogeropoulos, A. J., & Gibson, S. J. (1996). Fear of falling revisited. Archives 
of physical medicine and rehabilitation, 77(10), 1025-1029.
 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe whether the recordings 
will contain, or potentially contain, identifiers.  Note: use of photographs or recordings must be covered in the informed consent 
process and documented consent documents (e.g., consent form, information sheets, telephone screen scripts).
We will follow accepted standards for establishing and assessing treatment integrity and fidelity. This 
includes: a) treatment manual with weekly objectives, outcomes, and agendas, b) clinician training, and 
c) ongoing evaluation of treatment integrity through audio-rating of therapy sessions and supervision and 
weekly participant and clinician evaluations. All group sessions will be audio-recorded and available for 
rating. Supervisors (Drs. Schiehser and Twamley) will review all of the audio recordings for the first 
CogSMART-PD group and then will randomly select 10% of sessions thereafter for review. The supervisors 
will provide corrective feedback to the clinician, if needed. Audio recordings will be destroyed at the end of 
the study, and participants may refuse to be audio-recorded. Audio recordings transferred into a computer 
system will be assigned group numbers and will not be individually identifiable. The key that relates the 
group numbers to the individuals will be stored separately, protected by strong passwords, and accessible 
only by approved study personnel. On these recordings group members refer to each other by first name 
only, to ensure that they remain unidentifiable.
 Section 9.12 Off Station Activities
9.12) Describe each off-station activity including where it occurs, subject involvement, and any additional required protections.  
Note:  if the off-station activity is being conducted under the approval authority of another institution, this is not VA offsite research 
and should be described as collaborative research effort.  Please contact the HRPP office if you have any questions
Phase I:
100 participants will be scanned at the UCSD Keck Center for fMRI. 
Participants who consent to do so will participate in a home evaluation conducted within their home. One 
form which assess the home environment will be used for this assessment (please see appended form). 
All data collected during the home visits will only be identified by a subject ID number that is assigned 
during the consent process.
Phase II:
Up to 60 individuals may be scanned at the UCSD Keck Center for fMRI.
De-identified data from Motor Skills Assessments will be analyzed by collaborators in UC San Diego's 
Smart Lab, located in Atkinson Hall, 5202. No participant data will be collected at the Smart Lab.

De-identified saliva samples will be stored and analyzed by the UCSD Integrative Health and Mind-Body 
Biomarker Laboratory, located at the Medical Teaching Facility, Room 431. Samples are destroyed after 
analysis.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health status as 
appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you do not intend to contact the 
patients whose charts you will review, you still describe the characteristics related to the subjects whose charts you will review.   
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is confirmed if 
pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the local site's role as 
a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
Phase I:
Approximately 240 subjects in total will be recruited for this study: 20 PD patients to participate in 
CogSMART only (no imaging), up to 100 PD patients to participate in CogSMART and the imaging 
protocol, and 120 caregivers. The PD patients will range in age from 55-95. No patients under 55 will be 
imaged.
One hundred twenty individuals who have PD and documented cognitive impairment will be recruited from 
ongoing studies of neuropsychological functioning in PD (PI Filoteo). Over-recruitment by 10% will also be 
instituted to account for subject attrition or unusable data and to ensure a final sample size of 20 
participants (10 per treatment and 10 per wait list group) for Aims 1 and 2 and up to 100 participants for 
the Exploratory Aim. All PD participants will be screened and excluded if they have a history of significant 
head trauma, other neurologic or major psychiatric disorders, history of developmental learning disorder, 
substance dependence, or any contraindication to participating in the cognitive treatment. PD patients 
must be medically/clinically stable in order to be included in this study. The participant’s Parkinson’s 
disease diagnosis will be confirmed by the participating neurologists, and cognitive impairment (i.e., MCI 
or dementia) will be confirmed via neuropsychological testing and the consensus of the neuropsychologist 
investigators (Drs. Schiehser and Filoteo). We will also recruit any identified and consistent caregivers (e.
g., spouse, friend, relative) of the participants to complete several questionnaires regarding the 
participant’s quality of life and daily functioning prior to and following (immediately, 3- and 9-months) the 
intervention. All caregivers will be asked to participate if they do not have any known memory 
impairment, dementia, or another condition which would prevent them from accurately completing the 
questionnaires. 
PD participants may gain cognitive improvement and/or a delay in cognitive decline over time resultant 
from participating in this study with the additional scientific benefit of understanding the kinds of non-
pharmacologic interventions that may aid cognition in PD with cognitive impairment and/or dementia. 
Study participants will be provided with a CogSMART manual. Those individuals in the wait-list control 
group will be offered the cognitive treatment at the completion of the intervention period if they are 
interested. There will not be any direct benefit to the caregivers, however, the investigator and associates 
may learn more about how participation in a cognitive skills training course impacts the function and 
quality of life of individuals with Parkinson's disease. Additionally, we may learn if caregivers of individuals 
with Parkinson’s disease may benefit indirectly (e.g., improvement in caregiver’s quality of life) from the 
group participant’s (e.g., spouse, relative, friend’s) participation in the intervention. 
Inclusion of Women and Minorities: No exclusions will be made based on gender, race or ethnic 
background. Gender and ethnic composition of the samples will reflect that of the population of eligible 
patients presenting from the recruitment sources. 
Phase II:
We will recruit 110 individuals with Parkinson’s disease (PD) and Mild Cognitive Impairment (PD-MCI) 
primarily from the VA San Diego Healthcare System (VASDHS) Neurology and Neuropsychology Clinics, as 
well as 110 identified and consistent caregivers (e.g., spouse, friend, relative) of the participants to 
complete several questionnaires regarding the participant’s quality of life and daily functioning prior to the 
intervention, during follow-up visits, and after the intervention. However, as recruitment of women may 
be limited at the VA, we may need to recruit women outside of the VA to obtain a PD-epidemiologically 
accurate gender ratio of 60 (men)/40 (women). We will plan to recruit from the University of California, 

San Diego (UCSD) Movement Disorders Center as well as from additional sites (e.g., PD Association of 
San Diego, San Diego hospitals, private clinics, and the community). Participants will be included who are 
> 40 years of age, as < 40 years of age may represent a different form of PD. Participants will generally 
fall within the age range of 60-80 due to the prevalence of PD in these groups; however, no upper age 
limit or gender restrictions will be applied for this study.
Inclusion criteria: (1) Clinical diagnosis of PD based on the UK Brain Bank Criteria59 (2) Clinical diagnosis 
of MCI based on formal criteria set forth by the Movement Disorders Society (MDS) Task Force5, and 3) 
>40 years of age (due to likelihood that individuals <40 may represent a different form of PD than 
idiopathic PD). The PD diagnosis will be confirmed by one of the VASDHS/UCSD neurologists. The MCI 
diagnosis will be confirmed by a licensed clinical neuropsychologist (Drs. Schiehser or Filoteo). Level II 
MDS Task Force criteria is as follows: (1) cognitive decline reported by the patient or caregiver or 
observed by a clinician, (2) cognitive deficits not severe enough to significantly interfere with functional 
independence, and (3) cognitive deficits on formal neuropsychological testing including two tests for each 
of five domains: Attention, Language, Memory, Executive Function, and Visuospatial Ability5. As per MDS 
criteria, cognitive deficits will be determined by impairment (i.e., 1.5 standard deviations below 
appropriate norms) on either two tests in one cognitive domain or on one test in two different cognitive 
domains.
Exclusion criteria: (1) Secondary causes of Parkinsonism (e.g., corticobasal degeneration, progressive 
supranuclear palsy, multiple systems atrophy, drug-induced parkinsonism, etc.); (2) other neurological 
conditions (e.g., stroke); (3) normal or dementia diagnosis via neuropsychological testing and based on 
the MDS criteria for PD dementia; (4) psychosis, antipsychotic treatment or treatment for substance 
abuse; (5) untreated current major depression disorder or anxiety disorder; (6) uncorrected vision or 
hearing to adequately read the manual and hear intervention facilitator; and (7) reading level below an 
eighth grade level determined by a standardized reading test (Wide Range Achievement Test 4 - Reading 
[WRAT-4]60), as the intervention involves reading. In order not to overly restrict our sample and as 
almost all PD patients will be on some form of dopaminergic replacement therapy and various other 
medications for cognitive and mood symptoms (e.g., SSRIs), we will not exclude patients based on 
medications. However, we will ensure that participants are stabilized on medications by recruiting those 
patients who have not had any major changes in medications (i.e., PD medication regimen or 
antidepressant dosages) within 30 days of baseline testing and not including data in our analyses from 
any patient who had medication changes during the course of the treatment. We recognize that certain 
medications can worsen cognition, such as anticholinergic agents, amantadine, dopamine agonists and 
benzodiazepines61. Therefore, we will carefully document all medication types and dosages at each 
testing session and control for these in statistical analyses as needed. It is also recognized that 
medication changes may occur during and after the intervention. We will diligently record this changes 
and account for them in the analyses accordingly (e.g., as covariates).
There will not be any direct benefit to the caregivers, however, the investigator and associates may learn 
more about how participation in a cognitive skills training course impacts the function and quality of life of 
individuals with Parkinson's disease. Additionally, we may learn if caregivers of individuals with Parkinson’
s disease may benefit indirectly (e.g., improvement in caregiver’s quality of life) from the group 
participant’s (e.g., spouse, relative, friend’s) participation in the intervention. 
We expect no subjects once consented to fail the screening process.
 Section 10.1 Non-Veteran Subjects
10.1a)  Recruitment of non-Veterans cannot be for the sake of convenience for this study.  Provide the objective and justification 
for the inclusion of non-Veteran subjects.  Identify how the research results will be generalizable to the Veteran 
population.  Identify the approximate number of non-Veterans who will be enrolled.
Phase I:
Most participants will be recruited from ongoing studies of neuropsychological functioning in PD (PI 
Filoteo) which recruits both veteran and non-veteran participants.
In addition to recruiting patients within the VASDHS, subjects will also be referred to us through clinics at 
UCSD because the number of patients at the VASDHS is not sufficient alone to meet our enrollment 
requirement. Currently there are over 350 PD patients being followed clinically in the Neurology Service at 
the VASDHS and the UCSD Movement Disorders Clinics. VA neurologists follow approximately 150 PD 
patients at the VASDHS and, approximately 200 patients at UCSD. Roughly two-thirds of their new patient 
evaluations are for PD patients at varying stages of the disease. For both the VASDHS and UCSD clinics, 
about 40% of the patients currently being followed would likely meet the inclusion criteria for the 
proposed project, which would result in about 140 patients being eligible for the study, of those 140 about 
50% will have the necessary availability and schedule that can allow them to come to the VA weekly for 

12 weeks and undergo two fMRIs. There is also a 5%-10% exclusion for participants unwilling and/or 
unable to undergo MRIs for various reasons (claustrophobia, metal in eyes/head, physicals restrictions). 
Thus, in total, there are roughly 60-70 potential patients being followed continuously by the Movement 
Disorder specialists at the VA and UCSD (note this figure does not take into account potential new patient 
evaluations that will occur during the first year of recruitment). 
PD patients will be referred from outside of the VA to meet enrollment criteria within the study period. It 
is often the case that PD patients within the VA have multiple other risk factors associated with cognitive 
decline including histories of substance abuse, head injury, and psychiatric conditions that would preclude 
them from participating in our study. They also fMRI limiting factors, such as shrapnel in their bodies that 
exclude them from participation in fMRI. Thus, additional non-veteran subjects from UCSD will be studied 
as needed. 
Caregiver participation is necessary to measure the Parkinson's disease participant's quality of life. The 
caregivers enrolled in the study may be non-Veterans. 
Phase II:
We will primarily recruit Veterans with PD from the VASDHS Neurology and Neuropsychology Clinics. 
While we will attempt to exhaust recruitment at VA clinics first, recruitment of women may be limited at 
the VA, and therefore, we will receive referrals from outside clinics to obtain an epidemiologically accurate 
gender ratio of 60 (men)/40 (women). In this regard, we will primarily recruit from the University of 
California, San Diego (UCSD) Movement Disorders Center. The VASDHS/UCSD neurologists follow 
approximately 600 PD patients in the VASDHS clinics and approximately 600 PD patients within the UCSD 
Movement Disorders Clinic. Should it be necessary, we will recruit outside of the VA and UCSD, including 
recruiting from the Parkinson’s Association, San Diego area hospitals and clinics (e.g., Scripps and Sharp 
Healthcare Systems) who serve PD patients, private practices, and the community. It is estimated that 
there are 16,000-19,000 individuals living with PD in the San Diego area, of whom half are members of 
PASD. Our study team has ample experience recruiting from the community, including the use of flyers, 
tables at community-based events (e.g., PD Walks), and participation in PD-associated speaking 
engagements. San Diego contains a tight-knit community of professionals who work together to better 
serve individuals with PD and numerous people have expressed their support of this study.
10.1b) Non-Veterans must be given a copy of the VA Notice of Privacy Practices (NOPP) and sign the 
acknowledgement form.  The Privacy Officer must be notified when a non-Veteran is enrolled in the study and be 
provided with a copy of the signed NOPP.  If CPRS notes are entered, and the acknowledgement must also be 
scanned into CPRS.  The NOPP, Acknowledgement form, and instructions to provide the completed form to the PO 
are available under the ? at the top right corner of this page.
 Agree 
 Disagree
 Section 10.5 Individuals with Cognitive/Decisional Impairment
10.5) Provide the rationale and additional study procedures that will be required for including individuals with known cognitive 
impairment or institutionalized individuals.  Address Decisional Capacity Assessment and Surrogate Consent Sections 12.6 and 
12.7.
Phase I:
If participant lacks capacity to complete neuropsychological assessments, they will be thanked for their 
time and excused from the research study.
Phase II:
If a subject meets criteria for our study and is interested in participating, an appointment will be made to 
enroll the individuals in the study. Informed consent will be obtained at the time of visit. When the subject 
arrives for the appointment, a verbal explanation of the protocol will be given by the Principal Investigator 
or a member of the research team. A post-consent quiz will also be administered to ensure adequate 
understanding of the key elements of the study. If the subject performs adequately on the post-consent 
questionnaire, they will be asked to sign the consent form. If the subject is unable to demonstrate 
capacity to sign the consent form, they will be thanked for being a possible subject in the study and 

excused from the rest of testing. Given that we will be recruiting nondemented PD patients, it is not 
anticipated that any patients will be unable to consent.
Similarly, for individuals participating in the adjunct programs, informed consent will be obtained at the 
time of visit. When the subject arrives for the appointment, a verbal explanation of the adjunct programs 
will be given by the Principal Investigator or a member of the research team. A post-consent quiz will also 
be administered to ensure adequate understanding of the key elements of this portion of the study. If the 
subject performs adequately on the post-consent questionnaire, they will be asked to sign the consent 
form. If the subject is unable to demonstrate capacity to sign the consent form, they will be thanked for 
being a possible subject in the study and excused from the rest of testing. Given that we will be recruiting 
nondemented PD patients, it is not anticipated that any patients will be unable to consent.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). This description 
must include how, when, and where potential subjects are approached as well as procedures for identifying potential 
participants (through medical records, physician referral, third-party sources, etc.).  Include how selection is equitable.  Indicate 
if vulnerability to coercion may be present and if so plans to ensure voluntary participation.
Phase I:
At the time of their clinical or research visit in which they are identified as having PD with cognitive 
impairment and/or dementia, participants meeting inclusion criteria for this study will be approached 
about their interest in participating in the study. Potential participants will be informed of the study via a 
flyer (appended) and, if requested, study coordinators (e.g., Dawn Schiehser, Ph.D. or any co-investigator 
affiliated with the study) will contact the individual to explain the study procedures and answer any 
questions the potential participant may have. 
We will also recruit patients by placing announcements in local newsletters sent out by various Parkinson's 
disease support groups (e.g., the Parkinson's Disease Association of San Diego) and advertisements in the 
local media calling for potential research participants. The same wording as in the handout will be used for 
these announcements, except the phrase “You have been given this handout because you may be 
interested in participating in this study” will be removed. 
Approximately 60 PD patients (30 patients assigned to the intervention group and 30 patients assigned to 
the waitlist group)who meet the inclusion criteria to participate in the study will be asked if they would 
like to participate in the imaging protocol. Should they decline, they will participate in the non-imaging 
component of the study. 
Each participant will be asked if they have an identified consistent caregiver (e.g., spouse) who would like 
to participate in the study. If they answer in the affirmative, the caregiver will be contacted and informed 
of the study. If they agree to participate, the caregiver will be consented and asked to complete several 
questionnaires related to their assessment of the patient’s functioning at the time of the participants 
baseline assessment and again immediately following the intervention, and at 3- and 9-months post-
intervention. The caregivers participants will be invited to attend the CogSMART class solely as observers. 
Phase II:
Potential subjects may be referred from the VASDHS Neurology clinics of (or UCSD if needed). If the 
VASDHS neurologists feel that the patient is appropriate for the study, they will inform the patient about 
the study and provide a handout that briefly describes the study as well as appropriate contact numbers 
where the potential subject can call to obtain more information about the study. Potential subjects may 
also be referred from the Neuropsychology, Neurology, and/or other relevant clinics (such as Occupational 
Therapy or Physical Therapy) at VASDHS. If the patient is interested and willing, the treating provider will 
have the patient sign a Research Candidate Form on which they will provide a contact number. 
Alternatively, if the patient is interested and willing, the clinician will contact research study staff, who if 
available, will meet with the patient at the clinic to describe the study. In addition, the clinician will inform 
the research team of a potential research participant if they give verbal consent to the clinician to do so. 
In turn, the research team will send a letter to the patient informing them that study staff will be 
contacting them about the research study. If needed, we will recruit through other organizations 
(Parkinson’s Association, community) by use of flyers, brochures, and attendance at community events. 
Potential subjects may also be recruited by a search of ICD codes for Parkinson's disease and/or cognitive 
impairment in CPRS. Any patients not previously referred to our study from VASDHS clinics 
aforementioned, who may be eligible for the study, will be notified via the uploaded Recruitment Letter 
that a research assistant on this protocol will be contacting them approximately 2 weeks from the day the 

letter is sent. A research assistant will then call the patient to explain the study and gauge interest in 
participating. If the patient indicates that they are not interested, the research assistant will thank them 
for their time and will not contact them again regarding the study. Similarly, potential subjects may be 
recruited from co-investigators' research studies previously completed (e.g., Dr. Filoteo's research study). 
If a research participant who is potentially eligible for our study indicated in the previously completed 
research study that they would like to be contacted for future research opportunities, he or she will be 
informed of our research opportunities via the uploaded Previously Enrolled Subject Letter. A research 
assistant will then call the potential subject to explain the study and gauge interest in participating. If the 
patient indicates that they are not interested, the research assistant will thank them for their time and will 
not contact them again regarding the study. 
If the individual continues to show an interest in participating, he or she will be informed that they will 
need to be asked a series of screening questions related to their medical and psychiatric history. The 
potential subject will be informed that the information will be used solely to determine their potential 
eligibility for our study. They will be told that, if they agree to answer the questions, their information will 
be kept under lock and key in our laboratory and will not be available to any other individual outside of 
our research group.
If a subject meets criteria for our study and is interested in participating, an appointment will be made to 
enroll the individuals in the study. Informed consent will be obtained at the time of visit. When the subject 
arrives for the appointment, a verbal explanation of the protocol will be given by the Principal Investigator 
or a member of the research team. A post-consent quiz will also be administered to ensure adequate 
understanding of the key elements of the study. If the subject performs adequately on the post-consent 
questionnaire, they will be asked to sign the consent form. If the subject is unable to demonstrate 
capacity to sign the consent form, they will be thanked for being a possible subject in the study and 
excused from the rest of testing. Given that we will be recruiting nondemented PD patients, it is not 
anticipated that any patients will be unable to consent. A copy of the signed consent form and the 
Experimental Subject’s Bill of Rights is always provided to the subject. Participants will also provide 
written informed consent (HIPAA authorization) for their medical records to be viewed.
 Section 11.1 Recruitment Materials
11.1) Identify all recruitment materials (flyers, advertisements, letters, etc.) that will be used; include the web address for any 
web-based advertisements. The text of all communications with prospective participants must be reviewed and approved by the 
IRB before it can be used.  You will be reminded to attach copies of recruitment materials to the initial submission packet.  
Note:  Posting of flyers with pull tabs is not permitted within VASDHS (including the VMRF building).
Phase I:
We will also recruit patients by placing announcements in local newsletters sent out by various Parkinson's 
disease support groups (e.g., the Parkinson's Disease Association of San Diego) and advertisements in the 
local media calling for potential research participants. The same wording as in the handout will be used for 
these announcements, except the phrase “You have been given this handout because you may be 
interested in participating in this study” will be removed. 
Phase II:
We will also recruit patients by placing announcements in local newsletters sent out by various Parkinson's 
disease support groups (e.g., the Parkinson's Association) and advertisements in the local media calling 
for potential research participants. The same wording as in the handout will be used for these 
announcements, except the phrase “You have been given this handout because you may be interested in 
participating in this study” will be removed. 
Patients will also be recruited from other studies completed if they had indicated they would like to be 
contacted for future research opportunities. Patients may be made aware of this research opportunity via 
the uploaded Previously Enrolled Subject Letter, and will be called after the letter has been sent as 
outlined in the letter (~2 weeks after the letter is sent).
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:

12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or determining the 
eligibility of prospective subjects without (or prior to) obtaining informed consent of the prospective subject or the 
prospective subject’s LAR?
  Yes   
  No
12b) 
 informed consent
Signed
 Yes   
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
 Yes   
 No
12d) Request for a 
 of consent for all or some study activities.
waiver
  Yes   
  No
12e) Alteration of 
 of consent.
other required elements
  Yes   
  No
12f) 
assent to participate (Director approval will be required)
Child 
  Yes   
  No
12g) Will any language 
 be used by those obtaining consent and understood by the prospective 
other than English
participant or the legally authorized representative?
  Yes   
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
 Yes   
 No
12i) 
 consent (legally authorized representative)
Surrogate
 Yes   
 No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures except screening 
procedures with Consent/HIPAA waiver approval)?
 Yes   
 No
12.1b) Will the information being communicated to the participant or legally authorized representative during the consent 
process include exculpatory language through which the participant or legally authorized representative is made to waive or 
appear to waive any of the participant’s legal rights or release or appear to release the Researcher, Sponsor, the VA or its agents 
from liability for negligence.
  Yes   
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree 
 Disagree
12.1d) Identify the circumstances under which consent will be obtained including where the process will take place; any waiting 
period between describing the research and obtaining consent including sufficient time for the prospective participant to 
consider participation, and any steps taken to minimize the possibility of coercion or undue influence.
Phase I:

Informed consent will be obtained at initial visit. When the participant arrives for the appointment, Dr. 
Schiehser or a senior research assistant will discuss the consent form and administer a post-consent 
questionnaire to determine capacity to sign the consent form. If the participant performs adequately on 
the post-consent questionnaire, they will be asked to sign the consent form. If the participant is unable to 
demonstrate capacity to sign the consent form, the procedure for surrogate consent and decisional 
capacity will be enacted. If surrogate consent cannot be provided in this situation, the subject will no 
longer be included in the study. Copies of the Informed Consent and Informed Consent Exit Questionnaire 
(Evaluation of Decision-Making Capacity) forms have been attached. 
The informed consent procedure will adhere to the HIPAA Privacy Rule and all subjects will be given a VA-
specific HIPAA authorization form. 
Phase II:
Informed consent will be obtained at the time of initial visit. When the subject arrives for the 
appointment, a verbal explanation of the protocol will be given by the Principal Investigator or a member 
of the research team. A post-consent quiz will also be administered to ensure adequate understanding of 
the key elements of the study. If the subject performs adequately on the post-consent questionnaire, they 
will be asked to sign the consent form. If the subject is unable to demonstrate capacity to sign the 
consent form, they will be thanked for being a possible subject in the study and excused from the rest of 
testing. Copies of the Informed Consent and Informed Consent Exit Questionnaire (Evaluation of Decision-
Making Capacity) forms have been attached. 
Similarly, for individuals participating in the adjunct programs, informed consent will be obtained at the 
time of visit. When the subject arrives for the appointment, a verbal explanation of the adjunct programs 
will be given by the Principal Investigator or a member of the research team. A post-consent quiz will also 
be administered to ensure adequate understanding of the key elements of this portion of the study. If the 
subject performs adequately on the post-consent questionnaire, they will be asked to sign the consent 
form. If the subject is unable to demonstrate capacity to sign the consent form, they will be thanked for 
being a possible subject in the study and excused from the rest of testing. Given that we will be recruiting 
nondemented PD patients, it is not anticipated that any patients will be unable to consent.
The informed consent procedure will adhere to the HIPAA Privacy Rule and all subjects will be given a VA-
specific HIPAA authorization form. 
 Section 12.3 Waiver of Documented Consent
12.3a) Select one of the following situations permitting waiver of documented consent:
12.3a1) The only record linking the subject and the research would be the consent document and the principal risk would 
be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants 
documentation linking the subject with the research, and the subject's wishes will govern. Note: This criterion cannot be 
used for FDA-regulated studies.
  Yes   
  No
12.3a2) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context.
 Yes   
 No
12.3b) Is a waiver of the requirement to enter the consented subjects' names on a master list requested and appropriate in order 
to protect the subject’s privacy and the confidentiality of the data?
  Yes   
  No
 Section 12.6 Decisional Capacity Assessment
12.6a) Describe the method(s) for determination of decisional capacity: (see ? for guidance)  Please note that documentation of 
the assessement is required. 

Phase I:
Identifying Persons to Provide Surrogate Consent 
In a nonemergency room research environment, surrogate consent will be obtained from any of the 
following potential surrogates who has reasonable knowledge of the subject, in the following descending 
order of priority: 
1. The person's agent designated by an advance health care directive 
2. The conservator or guardian of the person having the authority to make health care decisions for the 
person 
3. The spouse of the person 
4. The domestic partner of the person as defined in Section 297 of the Family Code 
5. An adult son or daughter of the person 
6. A custodial parent of the person 
7. Any adult brother or sister of the person 
8. Any adult grandchild of the person 
9. An available adult relative with the closest degree of kinship to the person 
In a nonemergency room research environment, no surrogate consent will be utilized if there is a 
disagreement whether to consent among the members of the highest available priority class of surrogates 
(e.g., where two members of persons in the highest of categories, 5-7, disagree and there is no person in 
categories 1-4 available). 
In a nonemergency room research setting, the Investigator or designee will be responsible for ensuring 
that the surrogate 
• Has reasonable knowledge of the subject; 
• Is familiar with the subject’s degree of impairment; 
• Is willing to serve as the substitute decision maker; 
• Understands the risks, potential benefits, procedures and available alternatives to research 
participation; and 
• Makes his or her decisions based on the subject’s known preferences, and where the subject’s 
preferences are unknown, makes decisions based on the surrogate’s judgment of what the subject’s 
preferences would be if different from his or her own. 
Phase II:
A post-consent quiz will also be administered to ensure adequate understanding of the key elements of 
the study. If the subject performs adequately on the post-consent questionnaire, they will be asked to 
sign the consent form. If the subject is unable to demonstrate capacity to sign the consent form, they will 
be thanked for being a possible subject in the study and excused from the rest of testing. Given that we 
will be recruiting nondemented PD patients, it is not anticipated that any patients will be unable to 
consent. A copy of the post-consent questionnaire is attached.
Similarly, for individuals participating in the adjunct programs, a post-consent quiz will be administered to 
ensure adequate understanding of the key elements of this portion of the study. If the subject performs 
adequately on the post-consent questionnaire, they will be asked to sign the consent form. If the subject 
is unable to demonstrate capacity to sign the consent form, they will be thanked for being a possible 
subject in the study and excused from the rest of testing. Given that we will be recruiting nondemented 
PD patients, it is not anticipated that any patients will be unable to consent.
12.6b) If subjects with limited decisional capacity will be enrolled, describe methods for obtaining subject assent or why they are 
not indicated:
Obtaining Consent from the Surrogate 
1. The Investigator or designee will describe to potential surrogates the nature of ongoing decisions 
during the study regarding the subject’s participation, decision to participate in certain procedures, 
changes to the study, etc., in order to ensure that the surrogate will be willing to undertake these on-
going responsibilities. 
2. The surrogate will complete the “Self-Certification of Surrogate Decision Makers for Participation in 
Research” form as an attachment to the informed consent document for the research study, and keep the 
signed form along with a copy of the consent. In addition, the Investigator will keep a copy of this form in 
the research records along with the signed consent. The “Self-Certification of Surrogate Decision Makers 
for Participation in Research” form will verify the willingness of the person to serve as a surrogate, and 
detail the relationship of the surrogate to the subject and the surrogate’s qualifications demonstrating 
“reasonable knowledge” of the research subject. 
3. Potential surrogates will be advised that if a higher-ranking surrogate is identified at any time, the 
Investigator will defer to the higher-ranking surrogate’s decision regarding the subject’s participation in 
the research. 
4. For nonemergency room environment research only, if the potential surrogate identifies persons of a 
higher degree of surrogacy, the Investigator or designee will be responsible for contacting such individuals 

to determine if they want to serve as surrogate. 
5. Surrogates will be prohibited from receiving any financial compensation for providing consent. This will 
not prohibit the surrogate from being reimbursed for expenses that he or she may incur related to the 
participation in the research. 
6. Assessment of the decision-making capacity of the surrogate will be implemented only when the 
Investigator or designee has reason to believe that the surrogate’s decision-making capacity may be 
impaired. 
Reconsenting of Research Subjects 
Consenting will be an ongoing process. All applicable criteria that would trigger reconsenting a subject in 
any study will apply to subjects whose consent has been provided by a surrogate. In addition: 
• A subject who regains the cognitive ability to consent must be reconsented using standard consenting 
procedures. 
• In the event a subject has been initially consented by a surrogate, and a surrogate of higher priority 
subsequently notifies the Investigator of that relationship to the subject, the Investigator will defer to the 
higher-priority surrogate’s decision regarding whether the subject will continue to participate or will 
withdraw from the study. 
• The Investigator or designee will describe to potential surrogates the nature of ongoing decisions during 
the study regarding the subject’s participation, decision to participate in certain procedures, changes to 
the study, etc., in order to ensure that the surrogate is willing to undertake these ongoing responsibilities. 
In the event that the surrogate dies, the subject will be reconsented subsequently upon any event that 
would otherwise trigger re-consenting the subject. 
Phase II:
Subjects with limited decisional capacity will not be enrolled in phase II of the study.
12.6c) If subjects with limited decisional capacity will be enrolled, describe procedures for respecting subject dissent and any 
additional safeguards or why these features are not needed:
Phase I:
If the subject expresses resistance or dissent to participation or to the use of surrogate consent by word 
or gesture, the subject will be excluded from the research study. 
· If no resistance or dissent is expressed by the potential research subject, the Investigator or designee 
will document this fact, and document that the description of the research project was communicated to 
the subject by placing a note in the medical record and in the research record. 
· Proceed with the steps listed above under Identifying Persons to Provide Surrogate Consent 
12.6d) If subjects with limited decisional capacity will be enrolled, describe the risk and, if greater than minimal, the relation to 
potential benefits:
Phase I:
The primary risks in participating in this study are fatigue, test anxiety, and breach of confidentiality. As 
noted above, there are specific plans in place to lessen the likelihood of any of these potential risks. In 
contrast, the benefits of the study are much greater in that we could gain a better method of predicting 
future cognitive impairment in patients with PD. This knowledge has the potential to help patients, family 
members, and the patients’ physicians better prepare for and potentially treat the onset of any cognitive 
deficits observed as the disease progresses. As such, the risk to benefit ratio is low. 
Given that the primary risk to patients is that although there will be no direct benefit to participants for 
taking part in this study, we have found patients more than willing to participate in our previous studies. 
The study involves minimal risk and most participants are eager to contribute to an understanding of the 
cognitive effects of PD. 
12.6e) If subjects with limited decisional capacity will be enrolled, describe the justification for the inclusion of any incompetent 
persons or persons with impaired decision-making capacity:
Phase I:
The primary aim of this study is to examine cognitive deficits in patients with PD and compare the pattern 
of their deficits with other patient populations who also have cognitive impairment, including patients with 
Dementia with Lewy Bodies and Alzheimer's Disease, so by its very nature the study will include 
participants who might have impaired decision-making capacity.

 Section 12.7 Consent by Legally Authorized Representative (Surrogate Consent)
12.7a) Where endorsed by the IRB, the following persons may be authorized to consent on behalf of persons who lack decision-
 
making capacity in the indicated order of priority: (a) Health care agent (i.e., an individual named by the individual in a 
 
 
Durable Power of Attorney for Health Care (38 CFR.17.32(a)(iii)); (b) Legal guardian or special guardian; (c) Next of kin in this 
order: a close relative of the patient 18 years of age or older, in the following priority: spouse, child, parent, sibling, 
 
grandparent, or grandchild; (d) A close friend [however, California Health and Safety Code §24178 does NOT include the close 
 
friend category]  
 Agree 
 Disagree
12.7b) Legally Authorized Representatives (LARs) will be told that their obligation is to try to determine what the subjects 
 
would do if able to make an informed decision. If the potential subject's wishes cannot be determined, the LARs must be told 
 
they are responsible for determining what is in the subjects' best interests. LARs generally assume the same rights and 
responsibilities as the individuals who lack decision-making capacity in the informed consent process.
 Agree 
 Disagree
12.7c) If feasible, the investigator will explain the proposed research to the prospective research subject even when the surrogate 
gives consent.  Although unable to provide informed consent, some persons may resist participating in a research (i.e., if they 
dissent) protocol approved by their representatives. Under no circumstances may a subject be forced or coerced to participate in 
a research study even if the LAR has provided consent.
 Agree 
 Disagree
12.7d) For subjects with fluctuating decision-making capacity or those with decreasing capacity to give consent, a re-consenting 
process with surrogate consent will be employed when needed
 Agree 
 Disagree
 Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the  Help section**
? 
 Yes   
 No
12.9b) HIPAA waiver to cover the entire study
  Yes   
  No
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes   
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes   
  No
 Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers and health 
information are being requested under the waiver/alteration and identify whether the waiver is for access, use, and/or collection 
.
of this information
1) The waiver will be used to conduct a brief phone screen on potential patients referred to the study from 

outside the VASDHS as referenced in section 10.1. The phone screen will be used to determine eligibility 
for the study so that potential participants do not waste time traveling to the VASDHS. The data that will 
be collected under the waiver will include Name, address, phone number, veteran status, neurological 
diagnosis (if any), and the following 15 questions:
1. Are you 40 years of age or older? 
2. Is English your first language? 
3. Do you have any other neurological diagnosis besides PD? 
4. Do you have any other neurological condition, such as stroke or traumatic brain injury? 
5. Have you had DBS (deep brain stimulation) surgery? Other brain surgeries, or planned surgeries? 
6. Do you have a history of memory problems, or have you been diagnosed with dementia? 
7. Do you have any history of psychosis? 
8. Do you have any other psychiatric history (e.g. PTSD, Bipolar Disorder, Schizophrenia, etc.)? 
9. Do you have any history of major depression or anxiety (Past or current Dx)? 
10. Are you currently taking any antidepressant or antipsychotic medications? 
11.Have you ever been treated for substance abuse?
12. Have you ever had an acute medical crisis (major accidents, illnesses, etc.)?
13. Do you have any vision, hearing, or movement problems that could interfere with taking tests, 
reading, or interacting in a group setting?
14. Have you had any major changes in medications within the last month, or any anticipated within the 
next month?
15. Do you have a primary caregiver, spouse, relative, or close friend who would be able to answer 
questions about how you've been doing? 
2) The waiver will also be used to recruit potential study participants through the Neuropsychology, 
Neurology, and other relevant clinics at VASDHS. Patients who may be interested will be asked to sign a 
Research Candidate Form by their provider, and a research assistant will contact them if they indicate on 
the form that they agree to be contacted. Additionally, the provider may inform the research team of a 
potential study participant. At that point, a research assistant will either go speak to the patient in person 
about the study if the patient expresses interest in meeting with study staff, or will send the patient a 
letter (uploaded in protocol documents) stating that we will be calling them about a research opportunity. 
2b) The Research Candidate form asks for the patient's name, provider name, appointment day/time, and 
telephone number (if they indicate they would like to be contacted). Sending a letter will require patient's 
name, mailing address, and telephone number to later be contacted. 
2c) Sending the letter and making a follow-up phone call will require the patient's name, mailing address, 
and telephone number.
3) The waiver will also be used to reach potential study participants through CPRS (using the ICD codes 
for Parkinson's disease and cognitive impairment). For any patients who may be eligible, who were not 
previously referred to the research team by the clinician and did not sign a Research Candidate Form, will 
be sent a letter informing the patient that we will be calling them about a research opportunity. Sending a 
letter will require patient's name, mailing address, and telephone number to be contacted in the future.
3b) Recruiting by ICD code search requires knowing the patient's medical diagnoses (of Parkinson's 
disease and mild cognitive impairment). Sending the letter and making a follow-up phone call will require 
the patient's name, mailing address, and telephone number. 
4) Finally, the waiver will also be used to reach potential study participants through previously completed 
research studies, if they had agreed to be contacted for future research opportunities. Any patients who 
may be eligible will be sent the uploaded Previously Enrolled Subject Letter informing them of our new 
research opportunities, and letting them know that we will call to discuss these opportunities further with 
them. Sending this letter will require the patient's name, mailing address, and telephone number to be 
contacted in the future. 
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the privacy of individuals.
 Agree 
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree 
 Disagree
Describe the plan
A Privacy and Security Data Plan has been constructed to ensure confidentiality of all Sensitive 
Information (SI) and is outlined as follows:
1. This study will collect VA Sensitive Information (SI) (i.e., data, in any format, which requires protection 

due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration or 
destruction) from all participating subjects. SI used in this study will include individually identifiable 
medical and health data and personal information, such as age, educational level, gender and ethnicity. 
2. SI, such as subjects’ medical diagnoses, will be used for the purpose of enrollment and subjects’ 
personal information, such as age, gender, and education, will be used to characterize the subject pool 
utilized in this study. Addresses and telephone numbers will also be collected as a means to contact the 
subjects for follow-up when indicated. All data used in this study will be de-identified and linked to SI by a 
subject number.
3. SI will be used by approved study personnel only.
4. In the event of a real or suspected breach of security, the VA Police, the VA Information Security 
Officer, and the VA Privacy Officer will be notified.
5. Study records entered into a computer system will be assigned code numbers and will not be 
individually identifiable. The key that relates the code numbers to the individuals will be will be stored in a 
stand-alone (non-networked) computer system that is maintained in a locked office within the PI's lab 
space in Building #13 of the VA San Diego, protected by strong passwords, and accessible only by 
approved study personnel. This system will not leave the protected VA environment unless the data 
storage components are removed or destroyed. Hardcopy SI will also be stored for backup purposes in 
the PI’s laboratory within Building #13 of the VA San Diego, in a locked cabinet. Code-numbered data will 
be stored in a separate filing cabinet under lock and key in Building #13. Data collected in other areas 
(testing rooms) will be brought to the lab and locked away each night. Only approved study personnel will 
have access to this information.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless 
there is a health or research justification for retaining the identifiers or such retention is otherwise required by law.
 Agree 
 Disagree
12.10d2) Describe the plan:
SI, such as subjects’ medical diagnoses, will be used for the purpose of enrollment and subjects’ personal 
information, such as age, gender, and education, will be used to characterize the subject pool utilized in 
this study. Addresses and telephone numbers will also be collected as a means to contact the subjects for 
follow-up when indicated. All data used in this study will be de-identified and linked to SI by a subject 
number. Hardcopy SI will also be stored for backup purposes in the PI’s laboratory, within Building #13 of 
the VA San Diego, in a locked cabinet. Code-numbered data will be stored in a separate filing cabinet 
under lock and key in Building #13. We will need to keep this SI to maintain accurate characterization of 
our subject pool for subjects in follow-up, as medical diagnoses, addresses, and telephone numbers may 
change over the course of the study.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be reused or disclosed 
to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research 
 
for which the use or disclosure of protected health information would be permitted by the Privacy Rule. 38 U.S.C. 7332 
:  If the waiver of HIPAA authorization is for the use of 38 USC 7332 information (applicable to drug abuse, alcohol 
Information
abuse, HIV infection, and sickle cell anemia records), by signing this protocol for submission the PI is providing written 
assurance that the purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or subject identities in 
any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))
 Agree 
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree 
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
Without the phone screen for contact information and brief exclusionary criteria there would be no feasible 
way for us to send participants directions and appointment confirmation. There would also be potential for 
many participants to travel to VASDHS to participate in the study, sign a consent form only to find out 
they are ineligible for the study and be excused. This would waste the time of the participant as well the 
VASDHS.
The ability to contact VA patients directly will allow us to recruit more veterans to be enrolled in the 
study. Additionally, the ability to access medical diagnoses consistent with study inclusion criteria will 
reduce burden on potential study participants as we will not have to schedule additional appointments or 

testing to verify diagnoses of these patients. This will also reduce burden on clinicians who may not have 
time to recruit patients during busy clinic duties and will expand access to these services for Veterans who 
may not have any upcoming clinic visits in the near future.
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree 
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3/8/18)
1) The phone screen confirms the potential participant knows they have a diagnosis of Parkinson's disease 
which is a primary requirement of participation in the study.
2) The research candidate form allows research assistants on this protocol to call the patient and recruit 
them for the study, if interested and eligible. This form provides the means to contact the patient.
2b) The patient's name and mailing address will be required to send the letter before calling patients who 
were not presented the opportunity to sign the form (this includes subjects previously enrolled in other 
studies). The patient's phone number will be required to contact the patient after the letter is sent.
3) Accessing medical diagnoses in CPRS allows the research team to focus recruiting attention on those 
who are likely eligible (i.e., a veteran with Parkinson's disease and cognitive impairment). Additionally, 
having access to this information reduces participant burden; Veterans will not be scheduled for multiple 
testing sessions (through research and clinical services) and we will not have to schedule additional 
appointments or additional testing to verify diagnoses, as they are already listed on file. Furthermore, this 
will allow us to expand recruitment to Veterans who may not otherwise be reached within targeted clinics 
at VASDHS.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see ? for guidance)
Phase I & II:
The alternative to participating is to not participate.
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see ? for guidance)
Phase I:
The primary safety issues for this study are those related to mental fatigue, boredom and/or anxiety 
during the intervention or assessment. To ensure the safety and comfort of all subjects, rest breaks are 
built into CogSMART as well as the neuropsychological assessments. Participants will also be free to 
discontinue the intervention or testing at any time for any reason or to ask for additional rest breaks or 
other accommodations to increase tolerability of CogSMART or the paper-and-pencil testing. Home visits 
will be offered to the participants to increase functional gains, but further inclusion in the CogSMART 
program 10-week treatment group will not be denied if the participants and/or the caregivers decline this 
assessment. In general, the study poses no significant increase in risk than what would normally be 
present in proper clinical management of PD patients. The intervention is offered in a group format and 
there may be a somewhat greater risk of social discomfort and confidentiality breach than might be 
present in a non-group format. All group participants, however, will be strictly instructed on the need for 
confidentiality related to group membership and group proceedings. A tertiary risk might include 
unintentional disclosure of confidential test information but confidentiality will be strictly maintained in 
data storage, manipulation, and presentation. Participant identity will be coded immediately upon entry 
into the study, and neither the participants’ names nor any identifying information will be present in the 
data set. Presentation of the results will involve group data and the subjects’ identity will not be disclosed. 
Given the age and medical condition (i.e., Parkinson’s disease) of the participants, it is possible that 
individuals may experience medical or psychological changes, unrelated to the study that would 
necessitate early termination of the study. If the individual situation warrants, participants may be able to 
rejoin a later group. Because this is a psychoeducation group, not a therapy group, there is no 
expectation that individuals will divulge mental health related information during the 10-week course. 
However, should any such information arise that causes study staff to be concerned about that participant’

s psychological well being, appropriate referrals to either VA Geropsychiatry or other appropriate 
community referrals will be made. All intervention group participants will be provided with the class 
manual and so if there is a need for early termination with no opportunity to join another group, those 
individuals will still have the psychoeducation materials. 
MRI neuroimaging 
The primary safety issues for this study are those related to MRI scanning in general. MRI is a noninvasive 
procedure and overall, risks for MRI scanning are minimal given appropriate screening, which is done via 
an initial phone interview and again immediately prior to scanning. It is dangerous to be scanned if one 
has post-surgical metal clips in the body, metal implants, cardiac pacemakers, or any other possible 
ferrous-based device as outlined in the consent form. No such known cases will be scanned. MRI may not 
be appropriate under some of these conditions: a cardiac pacemaker; metal fragments in eyes, skin, 
body; heart valve replacement; brain clips, venous umbrella; history of being a sheet metal worker or 
welder; aneurysm surgery, intercranial bypass, renal, aortic clips; prosthetic devices such as middle ear, 
eye, joint or penile implants, joint replacements; hearing aid; neurostimulator; insulin pump; IUD; shunts
/stents; metal mesh/coil implants; metal plate/pin/screw/wire, or any other metal implants; permanent 
eyeliner, eyebrows. The MR imager makes a loud, banging noise while it takes pictures, but earplugs are 
provided. Sound pressure levels at the center of a head gradient coil were measured to be in the range 
from 122-131 dB SPL for a 3T scanner during echo planar imaging (Foster et al., 2000). 
Participants may experience vertigo, tinnitus, optic phosphemes or fasciculations during movement in the 
3T magnetic field. These symptoms are generally mild and transient, as will be explained to participants. 
Testing will be stopped at any time upon request. A physiological reaction (nerve or muscle stimulation) 
can occur in some individuals during certain imaging sequences if their position in the scanner forms a 
circuit (e.g., connected hands). Therefore, participants will be asked not to cross arms or legs and will be 
visually monitored to confirm this. Dizziness, excessive warmth, visual flashes, dots, scintillations, or 
tactile sensations due to rapidly switching gradients may also occur. Some patients undergoing this 
procedure become anxious or claustrophobic. If this happens, the subject can stop the procedure at any 
time. Subjects may experience some discomfort and fatigue from lying still in a confined space during 
imaging (total acquisition time for a particular MR imaging session will not exceed one hour for any study 
participant). Secondary risks include the possibility of an abnormal finding on the MRI exam, however, 
this MRI scan is not being done for clinical purposes, and is not sufficient for a clinical diagnosis of any 
brain disorder. We will notify participants and their physician in the event of any abnormal finding. As this 
is an experimental procedure, there are no alternative treatments, but subjects are free to discontinue 
participation at any time for any reason. 
Sensitive informaiton is not collected at the Keck Center. Patients are only identified by their subject ID 
number assigned prior to scanning. The VA Consent form is carried to the Keck Center so that the subject 
can undergo MRI scanning. The VA Consent form is carried back to the VA inside a locked briefcase and 
stored inside a locked cabinet inside a locked room 1-2304. The consent is not give or any information 
recorded at the Keck Center, it is mainly utilized to confirm subjects concurrence to undergo the scanning 
procedure Then, the subject is assigned a code to identify the scanned images. 
Wii participation
For those individuals who participate in the Wii adjunct program, there is an increased risk of physical 
injury, frustration and/or physical fatigue during the sessions. However, the Wii program is a low-exertion 
physical activity that only involves upper body (arm) movements. For those at risk of falling (as indicated 
by medical chart), we will have these patients sit in a chair while performing the Wii activities. Breaks and 
water will be frequently offered throughout the 30-minute session to prevent physical fatigue, frustration, 
and/or dehydration.
Phase II:
The primary safety issues for this study are those related to mental fatigue, boredom and/or anxiety 
during the intervention (CogSMART-PD) or the pre-, post- and follow-up assessments. To ensure the 
safety and comfort of all subjects, rest breaks are built into CogSMART-PD as well as the 
neuropsychological assessments. Participants will also be free to discontinue the intervention or testing at 
any time for any reason or to ask for additional rest breaks or other accommodations to increase 
tolerability of CogSMART-PD or the paper-and-pencil testing. The UPDRS motor examination may cause 
participant discomfort due to making motor movements. Prior to the motor exam, study staff will briefly 
explain what this exam will entail, and subjects may discontinue this exam at any time. The intervention 
is offered in a group format and there may be a somewhat greater risk of social discomfort and 
confidentiality breach than might be present in a non-group format. All group participants, however, will 
be strictly instructed on the need for confidentiality related to group membership and group proceedings. 
Given the age and medical condition (i.e., Parkinson’s disease) of the participants, it is possible that 
individuals may experience medical or psychological changes, unrelated to the study that would 
necessitate early termination of the study. If the individual situation warrants, participants may be able to 
rejoin a later group. Because this is a cognitive rehabilitation group, not a therapy group, there is no 
expectation that individuals will share personal and/or mental-health information. However, should any 

such information arise that causes study staff to be concerned about that participant’s psychological well 
being, appropriate referrals to the VASDHS Geropsychiatry Clinic or other appropriate community referrals 
will be made. As individuals with PD are at a high risk for falls, we will carefully screen all individuals for 
history of falls upon recruitment. We will use the baseline UPDRS falling item (#13) in which a history of 
falls is categorized on a likert scale from 0 (none) to 4 (falls >once per day). A history of falls as assessed 
by the UPDRS appears to be one of the best predictive methods of subsequent falls at this time. Those 
individuals who endorse a history of falling or score >0 on the UPDRS falling item, will be closely 
monitored. This includes ensuring that they are escorted to and from the intervention room from their 
vehicle as well as to and from the bathroom, as needed. Should a patient need help within the bathroom, 
a caregiver will be requested to assist. If needed, we will utilize the VA escort service. Although suicide is 
an extremely minimal risk factor for PD patients, suicidal ideation/intent will be assessed at baseline. Any 
indication of suicidal ideation will be brought to licensed and privileged supervisor’s immediate attention. 
All intervention group participants will be provided with the class manual and so if there is a need for 
early termination with no opportunity to join another group, those individuals will still have the 
psychoeducation materials. In general, the study poses no significant increase in risk than what would 
normally be present in proper clinical management and psychological treatment of PD-MCI patients.
A tertiary risk might include unintentional disclosure of confidential test information, but confidentiality 
will be strictly maintained in data storage, manipulation, and presentation. Participant identity will be 
coded immediately upon entry into the study, and neither the participants’ names nor any identifying 
information will be present in the data set. Presentation of the results will involve group data and the 
subjects’ identity will not be disclosed. 
MRI neuroimaging 
The primary safety issues for this study are those related to MRI scanning in general. MRI is a noninvasive 
procedure and overall, risks for MRI scanning are minimal given appropriate screening, which is done via 
an initial phone interview and again immediately prior to scanning. It is dangerous to be scanned if one 
has post-surgical metal clips in the body, metal implants, cardiac pacemakers, or any other possible 
ferrous-based device as outlined in the consent form. No such known cases will be scanned. MRI may not 
be appropriate under some of these conditions: a cardiac pacemaker; metal fragments in eyes, skin, 
body; heart valve replacement; brain clips, venous umbrella; history of being a sheet metal worker or 
welder; aneurysm surgery, intercranial bypass, renal, aortic clips; prosthetic devices such as middle ear, 
eye, joint or penile implants, joint replacements; hearing aid; neurostimulator; insulin pump; IUD; shunts
/stents; metal mesh/coil implants; metal plate/pin/screw/wire, or any other metal implants; permanent 
eyeliner, eyebrows. The MR imager makes a loud, banging noise while it takes pictures, but earplugs are 
provided. Sound pressure levels at the center of a head gradient coil were measured to be in the range 
from 122-131 dB SPL for a 3T scanner during echo planar imaging (Foster et al., 2000). 
Participants may experience vertigo, tinnitus, optic phosphemes or fasciculations during movement in the 
3T magnetic field. These symptoms are generally mild and transient, as will be explained to participants. 
Testing will be stopped at any time upon request. A physiological reaction (nerve or muscle stimulation) 
can occur in some individuals during certain imaging sequences if their position in the scanner forms a 
circuit (e.g., connected hands). Therefore, participants will be asked not to cross arms or legs and will be 
visually monitored to confirm this. Dizziness, excessive warmth, visual flashes, dots, scintillations, or 
tactile sensations due to rapidly switching gradients may also occur. Some patients undergoing this 
procedure become anxious or claustrophobic. If this happens, the subject can stop the procedure at any 
time. Subjects may experience some discomfort and fatigue from lying still in a confined space during 
imaging (total acquisition time for a particular MR imaging session will not exceed one hour for any study 
participant). Secondary risks include the possibility of an abnormal finding on the MRI exam, however, 
this MRI scan is not being done for clinical purposes, and is not sufficient for a clinical diagnosis of any 
brain disorder. We will notify participants and their physician in the event of any abnormal finding. As this 
is an experimental procedure, there are no alternative treatments, but subjects are free to discontinue 
participation at any time for any reason. 
Sensitive information is not collected at the Keck Center. Patients are only identified by their subject ID 
number assigned prior to scanning. The VA Consent form is carried to the Keck Center so that the subject 
can undergo MRI scanning. The VA Consent form is carried back to the VA inside a locked briefcase and 
stored inside a locked cabinet inside a locked room within the PI's lab space in building 13 (rooms 332 
and 306B). The consent is not give or any information recorded at the Keck Center, it is mainly utilized to 
confirm subjects concurrence to undergo the scanning procedure Then, the subject is assigned a code to 
identify the scanned images. 
Wii participation
For those individuals who participate in the Wii adjunct program, there is an increased risk of physical 
injury, frustration and/or physical fatigue during the sessions. However, the Wii program is a low-exertion 
physical activity that only involves upper body (arm) movements. For those at risk of falling (as indicated 
by medical chart), we will have these patients sit in a chair while performing the Wii activities. Breaks and 
water will be frequently offered throughout the 30-minute session to prevent physical fatigue, frustration, 
and/or dehydration.

Odoroki participation
For those individuals who participate in the Odoroki adjunct program, there is an increased risk of physical 
injury, frustration and/or physical fatigue during the sessions. However, the Odoroki program is a low-
exertion physical activity. For those at risk of falling (as indicated by medical chart), we will have these 
patients sit in a chair while performing the physical activities. Breaks and water will be frequently offered 
throughout the 60-minute session to prevent physical fatigue, frustration, and/or dehydration.
Saliva Sample
There is no identifiable bodily risk in taking a saliva sample beyond that of an ordinary medical 
examination; there is potential of small discomfort a mild scraping with a swab of the inside of the cheek 
to obtain the sample, and subjects that provide a saliva sample may experience dry mouth or difficulty 
producing saliva. Suggestions for improving saliva generation will be provided. The saliva sample will not 
be banked and, instead, the sample will be destroyed after processing.
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the adequacy of resources 
for conducting the study and resources participants may need as a consequence of the research.  When applicable, include detail 
of the following safety measures:   
(a) The type of safety information to be collected, including AEs; 
(b) 
Frequency of safety data collection; 
(c) Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the safety data to determine if harm is occurring; and 
(e) 
Conditions that trigger an immediate suspension of the research.  See ? for further 
requirements.
Phase I:
Test anxiety and fatigue will be minimized by explaining the testing procedures, by supportive assurance, 
and by taking brief rest periods throughout the evaluation. Pre-treatment evaluations will last 
approximately 2-3 hours and the home visit (optional) will last approximately 30 minutes for the PD 
participants. The caregivers’ participation will last approximately 30 minutes to 1 hour for completion of 
the interview and questionnaires and if agreed to, they will be involved in the 30-minute home evaluation. 
Each participant will be offered a home evaluation as part of the evaluation; however, should the 
participant or their caregiver decline this evaluation, the individual with PD will still be permitted to 
participate in the 10 week CogSMART treatment group. Each CogSMART session will last approximately 
two hours. Evaluations will be performed by examiners experienced in working with geriatric and 
neurologic populations. 
In order to protect individuals from a breach of confidentiality, sensitive information will be kept 
confidential by using coded numbers instead of names to identify individual protocols. All completed test 
material will be stored in a locked file cabinet in Dr. Filoteo’s laboratory at the VA Medical Center. A 
Privacy and Security Data Plan has been constructed to ensure confidentiality of all Sensitive Information 
(SI) and is outlined as follows: 
MRI Risk Management Procedures: 
The primary safety issues for this study are those related to MRI scanning in general. Overall, risks for 
MRI scanning are minimal given appropriate screening, which is done via an initial phone interview and 
again immediately prior to scanning. We will use a standard MRI screening form. This instrument has 
been used successfully in multiple protocols to exclude patients with suspected or known risk factors. If 
the screening form elicits any suspected risk factors, the form will be supplemented by review of medical 
records with the subject’s permission. In the case of possible risk related to medical implants, the 
manufacturer’s number of any implant will be cleared for safety with the CFMRI’s safety officer or the 
participant will not be scanned. As an additional precaution, subjects will be screened with a hand-held 
metal detecting wand immediately before entering the magnet room as a final confirmation that the 
participant is free of metal on their person. Subjects will be apprised of the risks as part of signing the 
consent form. Subjects with pacemakers, heart valves, brain clips, venous umbrellas, aneurysm surgery 
or intercranial bypass, aortic clips, prosthetic devices, neurostimulators, insulin pumps, shunts, metal coil 
implants, or other contraindications to receiving an MRI will be excluded. For any potential participant of 
childbearing age, they will assert that they are not currently pregnant or they will be excluded from 
imaging component of the study. To reduce risk of unwanted physiological reactions, participants will be 
monitored to ensure their body does not form a circuit (e.g., connected hands). Subjects will be strongly 
encouraged to move slowly when entering or exiting the magnetic field. The scanner bed has been 
designed to slowly move the subject so as to minimize the possibility of dizziness. RF-induced local 
heating is unlikely due to the software requirement that subject’s weight is accurately recorded and used 
in determining the appropriate changes in gradients. The participant will be reminded that he/she can 
discontinue the MRI portion at any time, before or during the scan. Risk of physical discomfort during 
imaging sessions will be minimized with attention to cushioning the subject's head, neck, shoulders and 
knees such that the patient may fully relax and not hold any tension to maintain position within the bore 

of the magnet. Rest breaks may be taken anytime; the patient is free to move about except during the 
approximate 0.50 to 1.0 hours of imaging time. The potential risk of hearing loss associated with the 
noise generated during MRI is eliminated using ear plugs (rated to reduce noise by 32 dB) and through 
the use of headphones (rated to reduce noise 30 dB). All participants will be required to wear hearing 
protection (e.g., ear plugs and headphones). Subjects will be told before being placed in the bore of the 
magnet that they may experience claustrophobia or other discomfort while in the magnet and that they 
should report this via the intercom should they experience any discomfort or feel the need to be removed, 
in which case imaging personnel will remove them immediately. The technician has continuous voice and 
visual contact with the participant. The technician will discontinue the scan at any time discomfort or 
excessive anxiety is apparent, and the participant can signal by voice, gesture, or alarm bell to 
discontinue the scan. Subjects will be told they are free to terminate the study at any time at no 
detriment to themselves or to any care they may be receiving from the VA. 
Discomfort during imaging sessions will be minimized with attention to cushioning the subject's head, 
neck, shoulders and knees such that the patient may fully relax and not hold any tension to maintain 
position within the bore of the magnet. The patient is free to move about except during the approximately 
¾ hour’s imaging time. Subjects will be told before being placed in the bore of the magnet that they may 
experience claustrophobia or other discomfort while in the magnet and that they should report this via the 
intercom as soon as they feel the need to be removed, in which case imaging personnel will remove them 
immediately. Subjects will be told they are free to terminate the study at any time at no detriment to 
themselves or to any care they may be receiving from the VA. The risk of imaging subjects with metal in 
their body, or who have pacemakers, will be eliminated by screening using a standard MRI screening 
form. This instrument has been used successfully in past protocols to exclude patients with suspected or 
known risk factors. This screening form is administered over the telephone when making the MRI scan 
appointment and again independently on the day of scanning. If the screening form elicits any suspected 
risk factors, the form will be supplemented by review of medical records with the subject’s permission. 
Finally, subjects will be asked the screening questions one more time by the MRI technician before being 
placed in the magnet and will be apprised of the risks as part of signing the consent form. 
Wii participation:
Wii games will be restricted to those requiring upper body movements (e.g., tennis, ping pong, and golf). 
For those at risk of falling (as indicated by medical chart), we will have these patients sit in a chair while 
performing the Wii activities. Breaks and water will be frequently offered throughout the 30-minute 
session to prevent physical fatigue, frustration and/or dehydration. 
Phase II:
Test anxiety, boredom and fatigue will be minimized by explaining the testing procedures, by supportive 
assurance, and by taking brief rest periods throughout the two-2.5 hour evaluation. Evaluations will be 
performed by examiners experienced in working with geriatric and neurologic populations and will be able 
to gauge when breaks are needed or when testing may need to be rescheduled or cancelled due to severe 
fatigue or anxiety. To minimize potential discomfort during the UPDRS motor exam, study staff will briefly 
explain the nature and purpose of the exam before beginning, and will instruct subjects to ask questions 
or communicate if they are unsure about or uncomfortable with any portion of the exam. Additionally, 
subjects will sign and receive a copy of the consent addendum, which has further details about the exam, 
prior to the exam. Each CogSMART-PD session will last approximately 1.5 hours and breaks are offered 
throughout the session as well. As individuals with PD are at a high risk for falls, we will carefully screen 
all individuals for history of falls upon recruitment. We will use the baseline UPDRS falling item (#13) in 
which a history of falls is categorized on a likert scale from 0 (none) to 4 (falls >once per day). A history 
of falls as assessed by the UPDRS appears to be one of the best predictive methods of subsequent falls at 
this time Those individuals who endorse a history of falling or score >0 on the UPDRS falling item, will be 
closely monitored. This includes ensuring that they are escorted to and from the intervention room from 
their vehicle as well as to and from the bathroom, as needed. Should a patient need help within the 
bathroom, a caregiver will be requested to assist. If needed, we will utilize the VA escort service. Although 
not common in PD, all participants will also be assessed for suicidal ideation/intent at baseline, as 
standard of care for psychological/behavioural interventions. If suicidal ideation is acknowledged, 
indicated by a score of 2 or greater on item 9 of the Beck Depression Inventory-II (BDI-II), research 
participants will be referred directly to a VA-privileged clinician for further evaluation. These participants 
will be monitored for changes in mood during the intervention. 
In order to protect individuals from a breach of confidentiality, sensitive information will be kept 
confidential by using coded numbers instead of names to identify individual protocols. Sensitive 
information (SI) will be kept on a secured computer system and a locked filing cabinet (for backup) in the 
PI's lab. All completed test material will be stored in a locked file cabinet in the PI’s laboratory within 
Building #13 at the VA San Diego Medical Center. A Privacy and Security Data Plan has been constructed 
to ensure confidentiality of all Sensitive Information (SI) and is outlined as follows:
1. This study will collect VA Sensitive Information (SI) (i.e., data, in any format, which requires protection 
due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration or 
destruction) from all participating subjects. SI used in this study will include individually identifiable 
medical and health data and personal information, such as age, educational level, gender and ethnicity. 

2. SI, such as subjects’ medical diagnoses, will be used for the purpose of enrollment and subjects’ 
personal information, such as age, gender, and education, will be used to characterize the subject pool 
utilized in this study. Addresses and telephone numbers will also be collected as a means to contact the 
subjects for follow-up when indicated. All data used in this study will be de-identified and linked to SI by a 
subject number.
3. SI will be used by approved study personnel only.
4. In the event of a real or suspected breach of security, the VA Police, the VA Information Security 
Officer, and the VA Privacy Officer will be notified.
5. Study records entered into a computer system will be assigned code numbers and will not be 
individually identifiable. The key that relates the code numbers to the individuals will be will be stored in a 
stand-alone (non-networked) computer system that is maintained in a locked office within the PI's lab 
space in Building #13 of the VA San Diego, protected by strong passwords, and accessible only by 
approved study personnel. This system will not leave the protected VA environment unless the data 
storage components are removed or destroyed. Hardcopy SI will also be stored for backup purposes in 
the PI’s laboratory within Building #13 of the VA San Diego, in a locked cabinet. Code-numbered data will 
be stored in a separate filing cabinet under lock and key in Building #13. Data collected in other areas 
(testing rooms) will be brought to the lab and locked away each night. Only approved study personnel will 
have access to this information. 
MRI Risk Management Procedures: 
The primary safety issues for this study are those related to MRI scanning in general. Overall, risks for 
MRI scanning are minimal given appropriate screening, which is done via an initial phone interview and 
again immediately prior to scanning. We will use a standard MRI screening form. This instrument has 
been used successfully in multiple protocols to exclude patients with suspected or known risk factors. If 
the screening form elicits any suspected risk factors, the form will be supplemented by review of medical 
records with the subject’s permission. In the case of possible risk related to medical implants, the 
manufacturer’s number of any implant will be cleared for safety with the CFMRI’s safety officer or the 
participant will not be scanned. As an additional precaution, subjects will be screened with a hand-held 
metal detecting wand immediately before entering the magnet room as a final confirmation that the 
participant is free of metal on their person. Subjects will be apprised of the risks as part of signing the 
consent form. Subjects with pacemakers, heart valves, brain clips, venous umbrellas, aneurysm surgery 
or intercranial bypass, aortic clips, prosthetic devices, neurostimulators, insulin pumps, shunts, metal coil 
implants, or other contraindications to receiving an MRI will be excluded. For any potential participant of 
childbearing age, they will assert that they are not currently pregnant or they will be excluded from 
imaging component of the study. To reduce risk of unwanted physiological reactions, participants will be 
monitored to ensure their body does not form a circuit (e.g., connected hands). Subjects will be strongly 
encouraged to move slowly when entering or exiting the magnetic field. The scanner bed has been 
designed to slowly move the subject so as to minimize the possibility of dizziness. RF-induced local 
heating is unlikely due to the software requirement that subject’s weight is accurately recorded and used 
in determining the appropriate changes in gradients. The participant will be reminded that he/she can 
discontinue the MRI portion at any time, before or during the scan. Risk of physical discomfort during 
imaging sessions will be minimized with attention to cushioning the subject's head, neck, shoulders and 
knees such that the patient may fully relax and not hold any tension to maintain position within the bore 
of the magnet. Rest breaks may be taken anytime; the patient is free to move about except during the 
approximate 0.50 to 1.0 hours of imaging time. The potential risk of hearing loss associated with the 
noise generated during MRI is eliminated using ear plugs (rated to reduce noise by 32 dB) and through 
the use of headphones (rated to reduce noise 30 dB). All participants will be required to wear hearing 
protection (e.g., ear plugs and headphones). Subjects will be told before being placed in the bore of the 
magnet that they may experience claustrophobia or other discomfort while in the magnet and that they 
should report this via the intercom should they experience any discomfort or feel the need to be removed, 
in which case imaging personnel will remove them immediately. The technician has continuous voice and 
visual contact with the participant. The technician will discontinue the scan at any time discomfort or 
excessive anxiety is apparent, and the participant can signal by voice, gesture, or alarm bell to 
discontinue the scan. Subjects will be told they are free to terminate the study at any time at no 
detriment to themselves or to any care they may be receiving from the VA. 
Discomfort during imaging sessions will be minimized with attention to cushioning the subject's head, 
neck, shoulders and knees such that the patient may fully relax and not hold any tension to maintain 
position within the bore of the magnet. The patient is free to move about except during the approximately 
¾ hour’s imaging time. Subjects will be told before being placed in the bore of the magnet that they may 
experience claustrophobia or other discomfort while in the magnet and that they should report this via the 
intercom as soon as they feel the need to be removed, in which case imaging personnel will remove them 
immediately. Subjects will be told they are free to terminate the study at any time at no detriment to 
themselves or to any care they may be receiving from the VA. The risk of imaging subjects with metal in 
their body, or who have pacemakers, will be eliminated by screening using a standard MRI screening 
form. This instrument has been used successfully in past protocols to exclude patients with suspected or 
known risk factors. This screening form is administered over the telephone when making the MRI scan 
appointment and again independently on the day of scanning. If the screening form elicits any suspected 
risk factors, the form will be supplemented by review of medical records with the subject’s permission. 
Finally, subjects will be asked the screening questions one more time by the MRI technician before being 

placed in the magnet and will be apprised of the risks as part of signing the consent form. 
Wii participation:
Wii games will be restricted to those requiring upper body movements (e.g., tennis, ping pong, and golf). 
For those at risk of falling (as indicated by medical chart), we will have these patients sit in a chair while 
performing the Wii activities. Breaks and water will be frequently offered throughout the 30-minute 
session to prevent physical fatigue, frustration and/or dehydration. 
Odoroki participation:
For those at risk of falling (as indicated by medical chart), we will have these patients sit in a chair while 
performing the Odoroki activities. Breaks and water will be frequently offered throughout the 60-minute 
session to prevent physical fatigue, frustration and/or dehydration. 
Saliva sample:
Saliva samples will be labeled with participant ID numbers and date of visit only, as outlined in HIPAA 
authorization. Labels will not contain any other identifiable information (such as name, SSN, or date of 
birth). Samples will not be banked and will be destroyed after analysis. 
 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see ? for guidance)
Phase I:
The expected outcomes for this program include improvement in cognitive, functional performance, and 
quality of life of PD patients as determined by neuropsychological and functional outcome measures. It is 
also hypothesized that caregiver’s quality of life will improve. Moreover, it is expected that participation in 
this program will result in fewer visits to VA or other medical services. That is, if the intervention results 
in prolonging of cognitive and functional independence, then the participants may utilize fewer medical 
resources in the long run. 
Phase II:
The expected outcomes for this program include improvement in cognitive, neuropsychiatric symptoms, 
and quality of life in PD-MCI participants. All participants will engage in some type of treatment (cognitive 
rehabilitation or supportive care), therefore, all participants are expected to benefit from participation in 
this study. We expect that there may be improvement in mood and quality of life in the control 
(supportive care) group participants. However, we predict there to be greater improvements and gains in 
the CogSMART-PD participants, especially as it pertains to cognitive function. In addition, it is possible 
that participation in the intervention and/or the study overall will result in fewer visits to VA or other 
medical services. That is, if the intervention results in prolonging of cognitive and functional 
independence, then the participants may utilize fewer medical resources in the long run.
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the 
importance of the knowledge that may reasonably be expected to result.
Phase I:
The study does not pose any major risks that are not commonly involved in the clinical management of 
PD patients, particularly those delivered in a group format. Given the potential of direct benefit to the 
CogSMART participants, the minimal risk associated with routine clinical management of PD appears 
reasonable.
Phase II:
The study does not pose any major risks that are not commonly involved in the clinical, psychological or 
behavioral treatment of neurological patients. Given the potential of direct benefit to the CogSMART-PD 
participants and the lack of current treatment options for PD-MCI, the minimal risk associated with this 
study appears reasonable.

 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See ? for detailed requirements.
Participants will receive a payment of $40 for each of the four assessments they complete (pre- and post-
intervention/support and 6- and 12-month follow-ups).
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Dawn M. Schiehser, PhD
Alan N. Simmons, PhD, Deborah L. Harrington, PhD, Elizabeth W. Twamley, PhD, J. Vincent Filoteo, PhD, 
Angelie Cabrera Tuazon, Stephanie L. Lessig, MD, Adan F Ton Loy, Aishee Das, Alexandra Leigh Clark, 
Beatrice M. White, Ece Bayram, PhD, Erin L. Almklov, PhD, Kaylee Bashor, Kelsey Anne Holiday, BS, Maya 
Bina Najmi Vannini, Michael J. Walsh, Nicole M. Whiteley, Tiana McMann
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the study staff are 
authorized to obtain consent, when applicable to the study. 
The CogSMART groups at the VASDHS will be led by Dr. Raeanne Moore, a Neuropsychologist with 
expertise in Parkinson’s disease and cognitive rehabilitation. All staff will be trained and closely supervised 
by Dawn Schiehser, Ph.D., Staff Neuropsychologist of the Cognitive Rehabilitation at the VASDHS with 
appropriate VA clinical privileges and a licensed psychologist in the state of California. Given that the 
CogSMART intervention is a psychoeducational program and not a therapy program, individuals with a 
Bachelor’s degree and appropriate training and supervision can lead the class. 
Dr. Filoteo is a licensed Clinical Psychologist with staff privileges at the San Diego VA and UCSD. Dr. 
Filoteo has conducted several neuropsychological studies in patients with Parkinson’s disease. He is 
authorized to obtain consent for subjects of VA research.
Dr. Dawn Schiehser is an Assistant Adjunct Professor at UCSD and a licensed Clinical Psychologist with full 
staff privileges at the VA San Diego who specializes in the cognition of movement disorder patients and 
individuals with traumatic brain injury. She is authorized to obtain consent for subjects of VA research. 
Dr. Stephanie Lessig is a board-certified neurologist with specialty training in movement disorders. She 
will administer the UPDRS Motor Examination to participants.
Angelie Cabrera Tuazon is the study coordinator and study contact in the lab. She will manage the study 
and be responsible for subject tracking, scheduling, and also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Nicole Whiteley is a research assistant in the lab and will also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Tiana McMann is a research assistant in the lab and will also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Kaylee Bashor is a research assistant in the lab and will also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Aishee Das is a research assistant in the lab and will also aid in subject recruitment. She is authorized to 
obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Beatrice White is a research assistant in the lab and will also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.

Adan Ton Loy is a research assistant in the lab and will also aid in subject recruitment. He is authorized to 
obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Maya Vannini is a research assistant in the lab and will also aid in subject recruitment. She is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Michael Walsh is a research assistant in the lab and will also aid in subject recruitment. He is authorized 
to obtain consent for subjects of VA research and administer neuropsychological tests involved with the 
study.
Dr. Ece Bayram is a research associate and post-doc fellow that will aid in administration of the UPDRS. 
Dr. Erin Almklov is a licensed Clinical Psychologist with staff privileges at the San Diego VA. Dr. Almklov 
will be assisting with assessing suicidality. 
Alexandra Clark is a post-doc fellow at the San Diego VA. She will be assisting with assessing suicidality. 
Kelsey Holiday is a research associate and WOC'd graduate student that will assist with assessing 
suicidality.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not include an extensive 
NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support the protocol or citations above.)
Aarsland D, Hutchinson M, Larsen JP (2003a) Cognitive, psychiatric and motor response to galantamine in 
Parkinson's disease with dementia. Int J Geriatr Psychiatry 18:937-941. 
Aarsland D, Zaccai J, Brayne C (2005) A systematic review of prevalence studies of dementia in 
Parkinson's disease. Mov Disord 20:1255-1263. 
Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P (2003b) Prevalence and characteristics of 
dementia in Parkinson disease: an 8-year prospective study. Arch Neurol 60:387-392. 
Aarsland D, Andersen K, Larsen JP, Lolk A, Nielsen H, Kragh-Sorensen P (2001) Risk of dementia in 
Parkinson's disease: a community-based, prospective study. Neurology 56:730-736. 
Nombela C, Bustillo PJ, Castell PF, Sanchez L, Medina V, Herrero MT Cognitive rehabilitation in Parkinson's 
disease: evidence from neuroimaging. Front Neurol 2:82. 
 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the assay kits).    Identify 
non-VA Research collaborators and their role in this protocol, including whether or not they have access to subjects or identified 
 
data.
Coded data from the Odoroki program will be analyzed by UC San Diego's Smart Lab, located in Atkinson 
Hall, 5202. No participant data will be collected at the Smart Lab. 
Saliva samples will be stored at and analyzed by the UCSD Integrative Health and Mind-Body Biomarker 
Laboratory, located at the Medical Teaching Facility, Room 431. Samples are de-identified, and are 
destroyed after analysis.
In the submission form, upload a copy of the grant, subaward, CRADA, etc. as appliable to the 
study.
 Section 27 - Privacy, Confidentiality, and Information Security

27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. Describe the 
circumstance under which it may be possible for a research team member to identify subjects and any related protections or 
assurances to prohibit or avoid identification. Describe how the number of people with access to identifiers for research 
purposes is limited in order to protect a participant’s privacy.
All data used in the study will be de-identified and linked to SI by an identifier number. SI will remain in a 
locked filing cabinet in the PI's lab space in building #13, separate from the de-identified data files, and 
will only be accessible by approved study personnel. 
In the groups, which are audio recorded, subjects are asked to call each other only by first name, to help 
avoid confidentiality breach. 
In the event of a real or suspected breach of security, the VA Police, VA Information Security Officer, and 
VA Privacy Officer will be notified.
Study records entered into a computer system will be assigned code numbers and will not be individually 
identifiable.
27.b) Entry of a CPRS 
is required when 
 
Research Informed Consent Note
subjects will be admitted as inpatients or treated as 
for research 
t
an outpatients 
 
and he study involves research medical care or may affect medical care.
If a Research consent Note is required, then a 
 should also be entered for each procedure or 
Research Progress Note
intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the Research Informed 
not required
Consent Note may be permitted and can be useful for trials involving the Research Pharmacy or when research will be 
performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 must be scanned into 
NOPP Acknowledgment
the record.  Otherwise a copy of the signed NOPP must be retained with the Investigator's research records and a copy sent 
to the Privacy Officer; see the
 Help for more information.
  ?
27.b1) Is entry of CPRS notes required based on the above criteria?
CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 
Identify for which group or groups CPRS records will be entered and to which groups this requirement does not 
apply.
CPRS notes will be entered for individuals who are consented and attend the treatment sessions. 
Caregivers who are enrolled into the study do not need CPRS notes because they do not attend treatment 
sessions nor receive any treatment. Additionally, there are cases where individuals consent to be in the 
study and complete neuropsychological assessments to determine eligibility but do not end up enrolling 
into group due to various reasons such as not being able to commit to the 10-week group, loss of 
interest, etc. In those cases, they do not attend the first day of group and do not receive any treatment; 
therefore, CPRS notes would not need to be entered for those individuals.
27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:

Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses
Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers
Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
SSN are needed for subject payment
27.1b) Consent Forms and/or HIPAA Authorization
 Yes   
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record numbers, dates, 
etc.)?
  Yes   
  No
27.1d) Photos with faces or audio video recordings are used for this study.
 Yes   
 No
27.1d1) Identify the device or devices that will be used to take/make the photographs or recordings. 
An audio recorder will be used to record group interventions to assess treatment fidelity.
27.1d2) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with study 
electronic VASI records
Audio recordings will be transferred to a computer system and assigned group numbers, and will not be 
individually identifiable. The key relating group numbers to the individuals will be stored separately, 
protected by strong passwords, and accessible only by approved study personnel.
27.1e) Biological specimens with identifiers are used for this study.

 Yes   
 No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
  Yes   
  No
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
  Yes   
  No
27.2c) Does the study require use of an electronic data capture system? 
  Yes   
  No
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, or processing 
data)?
  Yes   
  No
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers (per VHA 
all 
Handbook 1605.1 Appendix B), including dates
  Yes   
  No
 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
 Yes   
 No
27.3b) This study collects VASI outside of VA (i.e., at a non-VA location).
  Yes   
  No
27.3c) VASI is transported outside of VA for any purpose other than sharing.
  Yes   
  No

27.3d) PHI may be disclosed to monitoring/auditing agencies by HIPAA Authorization.  Note:  The Research Office must be 
notified when monitors come to audit
  Yes   
  No
27.3e) Data may be shared with collaborators or others in the conduct of this protocol.
 Yes   
 No
27.3e1)  Describe the data to be shared or disclosed, the entities to which the data are to be disclosed, how the data are to 
be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom. 
This includes data from individual subjects as well as other data developed during the research such as the analytic data 
and the aggregate data.  For PHI and VASI, indicate the authority/ies permitting the sharing or disclosure of data (HIPAA 
Authorization, Limited Data Set, Data Use Agreement, VA Form 10-5345-Request for and Authorization to Release 
Health Information., etc.).
De-identified data may be shared to be analyzed by the Smart Lab at UC San Diego. This de-identified 
data will be sent via encrypted email, and while being analyzed will be stored in a standalone (non-
networked), password-protected computer in the Smart Lab at UCSD. No participant data or identifying 
data will be collected at the Smart Lab, and no identifying data will be stored there.
 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes   
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room number, etc.  For 
each location identify whether VASI or non-sensitive information is stored at that location.  For VASI, identify how the 
data is secured. 
Neuropsychological tests, administered in a pencil-and-paper format, will be administered and recorded 
answers will be stored in the PI's lab space (rooms 330, 332, and/or 306B) in building 13.
27.4a2) Are all of the above locations at VA?
 Yes   
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes   
 No

27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map drive, network 
 
non-sensitive
location/server name, etc., and a brief description of what data/information is stored at each location.
Audio recordings of the intervention meetings will be transferred to the VA computer R drive so that 
investigators may assess treatment fidelity, and all audio files will be destroyed at the end of the study.
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, network location
 
VASI
/server name, etc., and a brief description of what data/information is stored at each location.
If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record VASI”.
Study does not collect or record VASI
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes storage on a 
computer local hard drive.
  Yes   
  No
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained for six 
years and then destroyed.  Longer retention may be permitted if requred by other Federal regulations or 
requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA Police (if 
appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree 
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they will not be allowed 
access to VA Sensitive Information.
 Agree 
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of the research team.
 Agree 
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control and only destroyed 
in compliance with the approved Records Control Schedule
 Agree 
 Disagree

The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research records will be 
assigned to another investigator and the Research Service notified in writing, or custody of the research records will be 
transferred to the Research Service.
 Agree 
 Disagree
 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is used for 
Initial Review Submission Form
attachments), please address the association of this Protocol to an R&D Committee Project.  This Protocol may represent a new 
R&D Project, or it may be an additional Protocol under an existing R&D Project (such as when a single grant supports multiple 
  
Protocols).  Will this Protocol be submitted to the R&D Committee as a new Project?
  Yes   
  No
 Section 29 - Existing Project Association
  
29) The associated R&D Project should already exist in the database.  Identify the R&D Project(s) that correspond to this 
protocol.
Project Status
Proposal Number
Project Title
Principal 
Investigator
Approved
1154731
1154731
Dawn M. 
Schiehser, 
PhD
Cognitive Rehabilitation in Individuals with 
Parkinson's Disease and Cognitive Impairment
 The Protocol Application is now complete for a Protocol attached to an existing 
Project.
 
Next you will go on to the Initial Review Submission Form.  This form is used to collect the 
Application and any other needed attachments for submission to the IRB for review.
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