IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers
Phase: NA
Conditions: Alzheimer's Disease (Incl Subtypes), Dementia, Mild Cognitive Impairment
Sponsor: Wake Forest University Health Sciences

Title:  IMOVE: A randomized, controlled trial of Improvisational 
MOVEment for people with memory loss and their caregivers
NCT03333837
Date: 11/18/20

Study Product Guidelines and Considerations 
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Version 6.0 
18 NOV 2020 
Clinical Intervention Study 
Protocol Template 

Study Product Guidelines and Considerations 
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Version 6.0 
 
 
18 NOV 2020 
IMOVE: A randomized, controlled trial of Improvisational 
MOVEment for people with memory loss and their 
caregivers 
 
Principal Investigators:   
Christina Hugenschmidt, PhD, Assistant Professor, Section on 
Gerontology and Geriatric Medicine, Wake Forest School of Medicine 
Christina Soriano, MFA, Director of Dance, Associate Professor, 
Department of Theatre and Dance, Wake Forest University 
 
Supported by:  
The National Center for Complementary and Integrative Health        
R01 AT009444 
 

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Tool Revision History 
Version Number: 2 
Version Date: 09/13/2017 
Summary of Revisions Made: Edits were made to clarify study endpoints, randomization scheme, 
details of statistical methods, and how missing data would be addressed statistically.  
 
Version Number: 3 
Version Date: 10/29/2017 
Summary of Revisions Made: Edited language about randomization scheme, included information 
about how data not missing at random would be statistically addressed. 
 
Version Number: 4 
Version Date: 11/09/2017 
Summary of Revisions Made: Edits were made in response to feedback from Westat to clarify study 
time windows; add information about planned study sites; add a table of exclusionary medications 
and renumber subsequent tables; clarify study alert information; add specific laboratory tests; and 
specified measures for monthly data QA. Additionally, added details about video storage and made 
minor formatting edits. Increased time since adjudication from 6 months to one year. 
 
Version Number: 5 
Version Date: 03/05/2018 
Summary of Revisions Made: Clarified inclusion criteria to specify that the caregiver who is a study 
partner for the person with dementia does not have to be the caregiver who accompanies the person 
with dementia to the intervention. At the recommendation of the ADC, cognitive testing for study 
outcomes changed to the Repeatable Battery for the Assessment of Neuropsychological Status, 
which has minor changes from the originally proposed battery. Added provision that participants who 
have had a comparable assessment of cognitive status to that provided through our clinics may 
participate in the study. Moved MoCA to BV1 and moved GDS, GAS, AES, and FES to BV2 for both 
PWD and CG. Clarified that stroke should be diagnosed by physician. Corrected baseline visit 
windows. Minor editorial changes. 
 
Version 5.1 
Version Date: 07/18/2018 
Summary of Revisions Made: All references to Visit 5 were removed.  
 
Version 5.2 
Version Date: 07/30/2018 
Summary of Revisions Made: Updates were made to inclusion criteria to allow for vascular 
dementia, lower MMSE cutoff score from 18 to 15, and allow for stroke upon approval of the study 
physician. These changes are made with the aim of improving recruitment without altering the aims, 
study design, or risk of the study. Also, the care partner role was modified to accept any person who 
spends approximately 10 hours per week with the participant, which is the current practice of the 
Wake Forest Alzheimer’s Disease Research Center. Finally, updated the randomization scheme 
such that it occurs over blocks of 16 instead of 32 dyads to decrease the amount of time between 
randomization and intervention start date and also to facilitate filling waves in local facilities such as 
churches or CCRCs.  

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Version 6.0 
Version Date: 11/18/2020 
Summary of Revisions Made:  Multiple changes are being made in response to intervention 
interruption due to COVID-19.  
• 
A new consent was added for those whose intervention was interrupted by COVID-19 
• 
Added protocol for collecting as many measures as possible virtually in the event this is 
necessary if safety concerns for in-person study visits arise. 
• 
Added details for performing intervention arms virtually. 
• 
Addition of an abbreviated screening visit for potential participants who previously 
completed full cognitive testing over 1 year ago and have an active diagnosis arrived at 
by as required in the study. The rationale for this is that especially in the case of a 
dementia diagnosis, it is virtually impossible for cognitive status to improve. Requiring 
people with established dementia to complete a full battery of cognitive testing can 
cause extreme distress in the person with dementia and yet provides little meaningful 
additional information in the context of establishing eligibility for this study. Caregiver 
concern about potential distress for the person with dementia has caused multiple 
potential participants not to screen for the study. In the case of an existing diagnosis of 
dementia, we propose to test global cognition with an MMSE to determine if the 
participant still falls within the established eligibility range for the study. In the case of 
MCI, under the guidance of the leadership of our Alzheimer’s Disease Research Center 
(ADRC), we propose to administer the Montreal Cognitive Assessment (MoCA). If the 
MoCA score is out of range for the study or has changed more than 3 points, a full 
cognitive testing battery would be performed. It is important to note that cognitive 
functioning will still be assessed with the RBANS pre- and post-intervention. 
• 
At the suggestion of the study monitor, lab alert values have been adjusted to better align 
with ranges prescribed by the lab analysis provider (LabCorp). Values requiring alerts and 
time windows for these alerts were also clarified. 
 

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TABLE OF CONTENTS 
Page 
Clinical Intervention Study Protocol Template ......................................................................... 1 
IMOVE: A randomized, controlled trial of Improvisational MOVEment for people with 
memory loss and their caregivers ................................................................................................ 2 
Tool Revision History ................................................................................................................. 3 
TABLE OF CONTENTS ............................................................................................................. 5 
STUDY TEAM ROSTER........................................................................................................... 8 
PRÉCIS ..................................................................................................................................... 10 
1. STUDY OBJECTIVES ........................................................................................................... 12 
1.1 
Primary Objective ......................................................................................................... 12 
1.2 
Secondary Objectives.................................................................................................... 12 
2. BACKGROUND AND RATIONALE .................................................................................. 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 12 
2.2 
Study Rationale ............................................................................................................. 13 
3. STUDY DESIGN ..................................................................................................................... 15 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 16 
4.1 
Inclusion Criteria .......................................................................................................... 17 
4.2 
Exclusion Criteria ......................................................................................................... 18 
4.3 
Study Enrollment Procedures ....................................................................................... 20 
5. STUDY INTERVENTIONS .................................................................................................. 23 
5.1 
Interventions, Administration, and Duration ................................................................ 23 
5.2 
Handling of Study Interventions ................................................................................... 26 
5.3 
Concomitant Interventions ............................................................................................ 28 
5.3.1 Allowed Interventions ............................................................................................... 28 
5.3.2 Required Interventions .............................................................................................. 28 
5.3.3 Prohibited Interventions ............................................................................................ 28 
5.4 
Adherence Assessment ................................................................................................. 29 
6. STUDY PROCEDURES ........................................................................................................ 29 
6.1 
Schedule of Evaluations ................................................................................................ 30 
6.2 
Description of Evaluations ............................................................................................ 32 

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6.2.1 Screening Evaluation ................................................................................................ 32 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 33 
6.2.3 Blinding..................................................................................................................... 37 
6.2.4 Follow-up Visits........................................................................................................ 37 
6.2.5 Completion/Final Evaluation ..................................... Error! Bookmark not defined. 
7. SAFETY ASSESSMENTS ..................................................................................................... 39 
Alphabetical List of Expected Adverse Events for Study Interventions ............................... 39 
7.1 
Specification of Safety Parameters ............................................................................... 39 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 42 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 42 
7.4 
Reporting Procedures .................................................................................................... 43 
7.5 
Follow-up for Adverse Events ...................................................................................... 44 
7.6 
Safety Monitoring ......................................................................................................... 44 
8. INTERVENTION DISCONTINUATION ........................................................................... 44 
9. STATISTICAL CONSIDERATIONS .................................................................................. 45 
9.1 
General Design Issues ................................................................................................... 45 
9.2 
Sample Size and Randomization .................................................................................. 47 
Treatment Assignment Procedures ....................................................................................... 48 
9.3  
Definition of Populations .............................................................................................. 49 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 49 
9.5 
Outcomes ...................................................................................................................... 49 
9.5.1 Primary Outcome ...................................................................................................... 49 
9.5.2 Secondary Outcomes ................................................................................................ 49 
9.6 
Data Analyses ............................................................................................................... 53 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 57 
10.1 
Data Collection Forms .................................................................................................. 57 
10.2 
Data Management ......................................................................................................... 57 
10.3 
Quality Assurance ......................................................................................................... 58 
10.3.1 
Training ................................................................................................................. 58 
10.3.2 
Quality Control Committee................................................................................... 58 
10.3.3 
Metrics .................................................................................................................. 58 
10.3.4 
Protocol Deviations ............................................................................................... 59 
10.3.5 
Monitoring ............................................................................................................ 59 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 60 

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11.1 
Institutional Review Board (IRB) Review .................................................................... 60 
11.2 
Informed Consent Forms .............................................................................................. 60 
11.3 
Participant Confidentiality ............................................................................................ 61 
11.4 
Study Discontinuation ................................................................................................... 61 
12. COMMITTEES..................................................................................................................... 61 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 62 
14. REFERENCES ...................................................................................................................... 62 
I. Procedures Schedule 
II. Informed Consent Form Template 
III. Other (add as many appendices as necessary) 

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STUDY TEAM ROSTER  
Co-Principal Investigator   Christina Hugenschmidt, PhD 
Sticht Center on Healthy Aging and Alzheimer’s Prevention 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157 
Email: chugensc@wakehealth.edu 
Phone: +1-336-713-4190 
Fax: +1-336-713-8588 
 
Co-Principal Investigator   Christina Soriano, MFA 
Department of Theatre and Dance 
Wake Forest University 
Winston-Salem, NC  
Email: sorianct@wfu.edu 
Phone: +1-336-758-4460 
Fax: +1-336-713-8588 
 
Statistician   
 
    Edward Ip, PhD 
 
 
 
 
    Department of Biostatistical Sciences 
 
 
 
 
    Wake Forest School of Medicine 
 
 
 
 
    Medical Center Boulevard 
 
 
 
 
    Winston-Salem, NC 27157 
 
 
 
 
    Email: eip@wakehealth.edu 
 
 
 
 
    Phone: +1-336-716-9833 
 
 
 
 
    Fax: +1-336-713-5249 
 
     
 
Co-investigators                 Paul Laurienti, MD, PhD 
 
 
 
 
   Department of Radiology 
 
 
 
 
   Wake Forest School of Medicine 
 
 
 
 
   Medical Center Boulevard 
 
 
 
 
   Winston-Salem, NC 27157 
 
 
 
 
   Email: plaurien@wakehealth.edu 
 
 
 
 
   Phone: +1-336-716-3261 
 
 
 
 
   Fax: +1-336-716-0798 
 
    Laura Baker, PhD 
          Sticht Center on Healthy Aging and Alzheimer’s Prevention 
          Wake Forest School of Medicine 
    Medical Center Boulevard 
    Winston-Salem, NC 27157 
    Email: ldbaker@wakehealth.edu 
    Phone: +1-336-713-8830 
    Fax: +1-336-713-8826 
 

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Interventionist   
    Jessie Laurita-Spanglet, MFA 
 
 
 
 
    Department of Theatre and Dance 
 
 
 
 
    Wake Forest University 
 
 
 
 
    Winston-Salem, NC 
 
 
 
 
    Email: lauritjs@wfu.edu 
 
 
 
 
    Phone: +1-336-758-7435 
    Fax: +1-336-713-8588 
 
Study Coordinators  
    Phyllis Babcock 
    Sticht Center on Healthy Aging and Alzheimer’s Prevention 
    Wake Forest School of Medicine 
    Medical Center Boulevard 
    Winston-Salem, NC 27157 
    Email: pbabcock@wakehealth.edu 
    Phone: +1-336-713-8542 
    Fax: +1-336-713-8588 
 
    Ashley Morgan 
    Sticht Center on Healthy Aging and Alzheimer’s Prevention 
    Wake Forest School of Medicine 
    Medical Center Boulevard 
    Winston-Salem, NC 27157 
    Email: armorgan@wakehealth.edu 
    Phone: +1-336-716-2513 
    Phone: +1-336-713-8588 
 
FREQUENTLY USED ABBREVIATIONS USED IN PROTOCOL (ALPHABETICAL ORDER) 
AD 
 
Alzheimer’s disease 
ADCC  
Alzheimer’s Disease Core Center 
CG 
 
Caregiver 
DSC 
 
Digit Symbol Coding 
fMRI 
 
Functional Magnetic Resonance Imaging 
MA 
 
Movement Alone 
MAC  
Memory Assessment Clinic 
MCI 
 
Mild Cognitive Impairment 
MG 
 
Movement Group 
MoCA  
Montreal Cognitive Assessment 
NC 
 
No Contact (control group) 
NPI 
 
Neuropsychiatric Inventory 
PWD  
Person With Dementia 
QoL 
 
Quality of Life 
RBANS 
Repeatable Battery for the Assessment of Neuropyschological Status 
SG 
 
Social Group 
 
 

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PRÉCIS  
Study Title 
IMOVE: Improvisational MOVEment for people with memory loss and their 
caregivers  
Objectives  
The overall aim of this proposal is to experimentally determine the independent and 
combined effects of dance movement and social engagement on quality of life (QoL) 
in people with mild cognitive impairment (MCI) and early-stage Alzheimer’s disease 
or vascular dementia, and test the neural mechanisms of these effects.  
Design and Outcomes   
We will use a 2x2 factorial design and randomize up to 120 older adults (age ≥ 60 
years) adjudicated as having MCI or early-stage ADRD to one of four 12-week 
intervention conditions: 1) Movement Group, 2) Movement Alone, 3) Social Group, 
or 4) No Contact Control.  
Active interventions (Movement Group, Social Group, Movement Alone) will occur 
twice weekly for 1 hour, for a total of 2 hours of intervention each week. 
The primary outcome is QoL in the person with memory loss. Secondary outcomes of 
interest include: 1) gait and balance assessed with an instrumented mat, force plate, 
Fullerton Advanced Balance Scale and Short Physical Performance Battery; 2) 
apathy, depression, and other neuropsychiatric symptoms in the person with dementia 
(PWD); and 3) changes in brain networks, especially somatomotor regions and the 
default mode network (DMN), assessed with graph theory analysis of resting-state 
functional magnetic resonance imaging (rsfMRI). 
Outcomes will be assessed prior to the intervention, within days 0-7 and within days 
1-21 following the last intervention date.  
Interventions and Duration  
The study will have four arms: 1) Movement Group (MG), 2) Movement Alone 
(MA), 3) Social Group (SG), or 4) No Contact (NC) control. Participants will be on 
study for up to 9 months, including time between screening and intervention 
initiation, and 2 follow-up visits off intervention. All intervention subjects will 
participate in two 1-hour intervention sessions each week for 12 weeks, for a total of 
24 hours of intervention.  
The Movement Group will participate in 1-hour group improvisational dance 
movement lessons twice a week for 12 weeks. Improvisational dance movement 
classes are grounded in 4 principles that shape the tone of the class and result in a 
sense of social belonging: non-judgment, non-competitiveness, curiosity, and 
playfulness. Training strategies used to maintain these qualities while moving are 
active imagination, variability, and pacing. These concepts are described in more 
detail in section 5.1.  
The general class structure has four phases. These include: (1) group warm-up in 
chairs positioned in a circle, (2) standing barre with solo- and partnering exercises, 

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(3) moving as a group through free space (with and without a partner), and (4) 
recuperation and rest. If participants are unable for any reason to perform exercises at 
the barre or move through free space, all exercises can be adapted for sitting. The 
choice to stand or walk is always self-selected by the participant. If the intervention is 
delivered in a virtual environment, the elements of group warm-up, standing barre, 
moving through free space, and recuperation and rest will still be performed. 
Participants will complete the movements at home while viewing the instructor and 
classmates via videoconference. Barre exercises will be adapted to use a chair for the 
barre. Partnered exercises will be accomplished by interacting with others in the 
videoconferencing environment. Group movements will be adapted as needed to 
accommodate movement in the home. 
The Movement Alone condition is designed to capture the same dance movement 
and auditory stimuli as the group class without social interaction. Recordings of the 
dance instructor teaching a dance class will be presented. This will ensure participants 
hear comparable music and receive comparable verbal auditory cues to prompt dance 
movements that students in the group class will hear, without interacting with other 
people. Participants will be asked to follow the same schedule as participants in the 
Movement Group arm and complete two 1-hour dance sessions per week. If the 
intervention is delivered virtually, recordings and music will be presented to the 
participant via videoconferencing software that is monitored and operated by study 
staff. 
The Social Group will consist of improvisational party games that foster curiosity 
and playfulness, use imagery, and encourage non-judgment. Games that may be used 
include ‘Balderdash’, ‘Wise and Otherwise’, ‘Pictionary’, and ‘Tell Me A Story’ 
cards. These games will also use the same core strategies as the dance group. Games 
will be varied within an hour-long session to incorporate pacing and variability into 
the social group, akin to the dance group. The social group will occur 2x/week for 1 
hour each time and be led by the same instructors who lead the Dance Group, to 
control for effects of personality of the group leader. If the intervention is delivered 
virtually, games will be led by the same instructors over videoconferencing software. 
The No Contact condition captures the condition of no added social contact and no 
added dance movement. Participants randomized to the No Contact condition will be 
asked to continue their current disease management and lifestyle for 12 weeks. The 
condition of not receiving an intervention can have ethical implications and reduce 
retention rates. Therefore, these participants will be invited to join in a weekly 
community improvisational dance class after they complete the study, for as many 
sessions as they would like, or to participate in a MG arm if space allows. If the 
intervention is delivered virtually, NC participants will be invited to participate in 
community classes offered with the same virtual format. 
Sample Size and Population  
We aim to enroll up to 120 people with mild cognitive impairment or early-stage 
dementia aged 60-85 and their caregivers in dyads (pairs), for a total of 240 
individuals. The main outcomes are powered on the number of PWD, as those are the 
primary outcomes of interest. Participants will be randomized equally to one of the 

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four groups, for a total of 30 dyads in each group. The target population is people 
adjudicated as having mild cognitive impairment or early-stage dementia aged 60-85. 
Cognitive status will be determined by combining information from 1) a cognitive 
test battery that is either the National Alzheimer’s Coordinating Center (NACC) 
Unified Data Set (UDS) or comparable battery, 2) self-report forms including 
depressive symptoms, 3) caregiver-report of functional status and neuropsychiatric 
symptoms, and 4) the Clinical Dementia Rating scale (CDR). We anticipate most 
study participants will be referred to the study after being adjudicated by consensus 
using the above information either in the Wake Forest School of Medicine Memory 
Assessment Clinic (MAC) or the Alzheimer’s Disease Core Center (ADCC). 
Participants from the community can also be included by completing the above 
testing, being adjudicated as having mild cognitive impairment or early-stage 
dementia, and meeting study inclusion/exclusion criteria.  
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
The primary objective of this proposal is to experimentally determine the independent 
and combined effects of dance movement and social engagement on quality of life 
(QoL) in people with mild cognitive impairment or early stage dementia. 
1.2 
Secondary Objectives 
 
The secondary objectives of this proposal include assessing the neural mechanisms 
of the effects of dance movement and social engagement, and to assess potential 
mechanistic links between functional neuroimaging metrics, behavioral outcomes, 
and overall QoL scores using structural equation modeling in all groups combined. 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Dementia is a progressive decline in cognition that impairs a person’s ability to 
perform activities of daily living. Alzheimer’s disease (AD) is the most common form 
of dementia, the most common neuro-degenerative disease in older adults, and the 6th 
leading cause of death in the US.[1] It is the only one of the top 10 leading causes of 
death with no disease-altering treatment or cure, meaning that all current medical 
treatments for AD are essentially palliative, aimed at controlling symptoms rather 
than altering the course of the neuropathology underlying the disease. Care for AD 
and other related dementias (ADRD) was estimated to cost the United States 
approximately $203 billion in 2013, and that cost is estimated to increase to over a 
trillion dollars by 2050.[1] Costs for AD are high because of the need for specialized 
in-home and institutional care as the disease progresses, and also due to increased 
healthcare costs for caregivers. In addition to lost time at work, the medical costs 
arising from the stress of dementia caregiving are estimated to be around $9.1 billion 
a year [1]. Research has convincingly demonstrated that caregivers of a person with 
dementia face increased levels of stress that tax their health [2-7] above and beyond 

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caregiving for people with other needs,[1] and to the extent that they may increase 
mortality.[8]  
Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance 
are prominent secondary symptoms of AD that increase medical costs and decrease 
quality of life (QoL) for the person with dementia (PWD) and their caregiver 
(CG).[9-11]  In a report from the Secretariat (Executive Board, 134th Session, 
December 20th, 2013), the World Health Organization identified a need to integrate 
evidence-based palliative care services into the continuum of care for serious chronic 
diseases, including AD. However, two recent NIH workshops identified major gaps in 
the evidence supporting the wider use of non-pharmacologic activities to ameliorate 
secondary symptoms of chronic disease. Arts-based activities were identified as 
particularly understudied for symptom management, given growing evidence that 
various arts-based activities can improve QoL, relieve symptoms, and reduce reliance 
on medications.[12] Dance is an arts-based activity that can improve QoL, decrease 
symptoms of depression, and improve balance in healthy older adults[13-15], those 
with Parkinson disease,[16-21] and AD.[22, 23]  Thus, dance simultaneously 
addresses two sets of prominent secondary symptoms in AD: 1) gait and balance and 
2) neuropsychiatric symptoms. 
 
2.2 
Study Rationale 
Changes in gait, balance, and neuropsychiatric symptoms that accompany 
dementia decrease QoL and increase the need for formal care. PWD are at 
increased risk for hospitalization from falls relative to their non-demented peers.[24-
26] The increased risk of falls in PWD is likely due to well-documented changes in 
balance and gait. In PWD, fall risk is associated with the same measures as in non-
demented older adults, such as postural sway, stance, and gait speed.[27, 28] PWD 
have lower scores on the Short Physical Performance Battery (SPPB),[28, 29] a 
global measure of mobility disability risk that assesses balance, strength, and gait 
speed.[30] They also show a 32% increase in postural sway assessed with a force 
plate.[31] Changes in gait speed are common[29, 32, 33] and can precede dementia 
onset.[34-40] Other gait changes include increased stride variability,[33] increased 
compensation movements,[41] and decreased stride length in single and dual-task 
conditions.[29, 32] Changes in gait are detectable early in the course of AD and 
decline further as dementia advances.[42, 43] Gait speed changes in PWD correlate 
with beta amyloid accumulation using positron emission tomography,[44] and 
increased white matter lesion burden and decreased grey matter in motor-related 
regions on MRI.[45]  
Neuropsychiatric symptoms such as higher levels of depression, anxiety, and apathy 
are prevalent in PWD, with estimates ranging from 40-73%.[46] There is a clear link 
between neuropsychiatric symptoms in the PWD and increased CG burden. In one 
study, subclinical anxiety or depression added 10 hours of caregiving each week, and 
the added amount of caregiving approximately doubled if neuropsychiatric symptoms 
reached clinically significant levels.[10] Dementia caregivers are more likely to visit 
the emergency room or be hospitalized if the person they care for is depressed or has 

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behavioral disturbances.[11] In addition, caregivers are more likely to place a PWD in 
a nursing home if they report being stressed by neuropsychiatric symptoms.[9]  
Dance can improve symptoms of depression and improve gait and balance. There 
is growing evidence that dance improves or maintains physical function, mood, and 
QoL in older adults. In a longitudinal observational study evaluating relationships 
between leisure activities and risk of dementia, dancing was associated with reduced 
risk of dementia.[13] Older dancers have better gait and balance in cross-sectional 
studies,[14, 47] and participating in dance interventions (tango, folkloric) is 
associated with improved balance and gait[18, 48, 49] mental health and 
depression,[18, 50, 51] and QoL.[18, 50, 52, 53] In people with Parkinson disease 
(PD), the second most common neurodegenerative disease in older adults after AD, 
group-delivered dance classes in ballet, modern dance, Argentinian tango, and other 
forms of social and ballroom dance improved balance, gait, and QoL.[16-21]  A 
recent review of controlled trials[20] found that in people with PD, dance improves 
balance and QoL more than common forms of aerobic exercise such as cycling and 
walking. Evidence of the effects of dance on PWD is limited, yet aligns with the 
findings from older adults and people with PD. In PWD, dance can improve QoL, 
gait and balance,[54] and symptoms of depression.[22, 23]  
Improvisational dance may have unique benefits for older adults with neuro-
degenerative disease. Improvisation is the ability to create new gestures and 
movements spontaneously.[55] Improvisation can be a part of many different art 
forms. However, improvisational dance can be practiced as a specific dance form. 
The objective in improvisational dance is that choreographed or prescriptive 
movement is replaced by the possibility for multiple physical responses.  
Improvisation does not mean that people are free to do whatever they want; material 
may be unplanned, but it is not random.[56] Instead, improvisation allows movers to 
make choices within a structured environment of select constraints.[57, 58]   
Two key differences that distinguish teaching improvisational dance as the primary 
dance form from encouraging improvisation around another form of dance are 1) the 
use of auditory cueing and music, and 2) repetition of choreographed or codified 
dance movements. In improvisational dance, verbal auditory cueing is used to convey 
improvisational ideas that elicit movement from students in the class. Because verbal 
auditory cueing does not instruct explicit movements, participants self-select motor 
strategies in response to the prompt that vary in terms of shape of movement, spatial 
usage, and timing. Unlike many other forms of dance or exercise, there are few 
specific movements that are repeated or over-trained in this form of dance.  
Improvisational movement is particularly well-suited for people with dementia 
because 1) it does not rely heavily on memory; 2) it can be seamlessly adapted to 
include students sitting, standing, or moving around the room; 3) it is cognitively 
challenging; and 4) it fosters a social, playful atmosphere. 
Duration of Intervention. Intervention duration (8 weeks in the pilot, 12 weeks 
proposed): The duration of the pilot was largely dictated by our pilot funding 
timeline, but it is also supported by literature. There is no consensus on optimal 
duration of a dance intervention with quality of life and biomarker outcomes in 

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cognitively impaired participants. Determination of optimal intervention time is 
complicated by the variability in the dance literature in terms of population 
(Parkinson’s disease, stroke, cancer, youth, older adults, etc.), outcomes (gait, 
balance, UPDRS, falls, depression, various forms of quality of life, etc.), and form of 
dance studied (Tango, ballroom, social dance, folkloric dance, ballet, etc.).  
The literature on Parkinson’s disease (PD) and dance is the most established body of 
work. One study examined effects of Tango on physical function at baseline, 3 
months, 6 months, and 12 months.[59] Significant improvement was seen at 3 months 
and the largest gains in improvements for the Unified Parkinson’s Disease Rating 
Scale (UPDRS) and gait speed were seen by 6 months. This study is in a different 
population and used different outcome measures than the proposed trial, but supports 
the idea that collecting data beyond 8 weeks may increase the observed effect size. 
We know of only 3 published dance interventions in people with dementia. The first 
two met twice a week for 6 weeks. One looked at solely qualitative outcomes 
(n=7),[23] so it is not possible to evaluate magnitude of effect size. The other reported 
robust effects of poco poco dancing (n=44) versus a relaxation control (n=40) on 
quality of life measured with the QOL-AD (η2=0.29, p<0.001) in Malaysian older 
adults with cognitive impairment living in government-run residential homes. 
However, the authors describe the method as “quasi-experimental” and the methods 
and population are not thoroughly described.[22] The third study examined the effects 
of a twice-weekly 12-week salsa dancing intervention in a single 84-year old woman 
with Alzheimer’s disease.[54] Outcomes were measured at baseline, 6 weeks, and 12 
weeks. Scores on the Berg Balance scale, 6-minute walk test, 10 meter walk test, and 
timed up and go test all continued to improve between 6- and 12-week time points. 
This supports the idea that increasing the length of intervention to 12 weeks may 
increase the observed effect size.  
None of these studies had brain imaging or other biomarker outcomes. A recent 
review of the effects of dance in older adults found no published trials of 
neurobiological factors.[60] The proposed study will provide important, first-ever 
data about the effect sizes for neurobiological outcomes in a randomized, 
controlled trial of dance in older adults with cognitive impairment. 
Potential Risks. The movement class has been taught safely to groups with 
Parkinson disease for 5 years now in the community, and was completed safely in the 
pilot study by people with early-stage memory loss. However, as with any class that 
involves moving, there is a risk of tripping, falling, or temporary muscle soreness. To 
protect against fall risk, all exercises in the movement arms can be adapted for sitting; 
standing or walking are always optional. Participants will be encouraged to pay 
attention to their own body and make movements that feel safe for them. 
3. STUDY DESIGN 
We will use a 2x2 factorial design to test the separate and combined effects of social 
engagement and dance movement on QoL in 120 community-dwelling older adults 
adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of 
the presumed AD, mixed AD/vascular type, or vascular dementia. Participants will be 

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randomized to one of four 12-week interventions (n=30 PWD per group): 1) 
Movement Group 2) Movement Alone, 3) Social Group, or 4) No Contact Control. 
The primary outcome of the study is QoL in the PWD. Secondary outcomes include 
gait, balance, neuropsychiatric symptoms, and functional brain imaging. Study 
measures will be collected at an academic medical center. Study interventions will 
take place in the community, at the academic medical center, or in the case of virtual 
intervention, in the participant’s home environment.  
The entire trial will last for 4 years. Enrollment is planned to occur over 3.5 years. 
Individual participants will be enrolled in the trial for up to 9 months. Study staff will 
be blind to each individual’s group assignment at baseline. Two study staff will be 
unblinded after baseline testing for the purpose of scheduling and reminder calls 
during the intervention. Participants in MG, MA, and SG intervention arms will 
complete two 1-hour intervention sessions each week for 12 weeks, or 24 sessions 
within 13 weeks (to allow for illness, etc.) before follow-up testing. Participants 
randomized to the NC arm will be asked to maintain current medical treatment and 
lifestyle for 12 weeks.  
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
Recruitment. Participants will be recruited through the WFSM Memory Assessment 
Clinic (MAC) and the WFSM Alzheimer’s Disease Core Center (ADCC). The 
assessments in these two settings are highly overlapping and will ensure consistency 
in diagnosis. People who are adjudicated within the previous year as having MCI or 
early-stage dementia of the AD, vascular, or mixed AD/vascular type and their CGs 
will be invited to participate. The study aims to recruit up to 120 men and women 
with dementia over 3.5 years. Of the 400 older adults seen annually in the MAC, 
about 160 are diagnosed with dementia (all causes), 200 with MCI, and 40 are judged 
to be unimpaired. The recently NIH-funded WFSM ADCC has characterized and 
currently follows 250 older adults at high risk of or with dementia through their 
Clinical Core, and over the next year an additional 200 individuals will be added to 
the cohort. Co-investigator Laura Baker, PhD, is Associate Director of the ADCC and 
will ensure appropriate participants are available for the proposed study. Additional 
participants recruited through the community will be adjudicated through the ADCC. 
Adjudication of cognitive status. Patients in the MAC and the ADCC undergo a 
cognitive evaluation that includes a neuropsychological test battery, functional status 
questionnaires completed by a proxy, and a history and physical by a board-certified 
geriatrician. Persons without recent imaging or blood work to rule out reversible 
causes of cognitive impairment receive standard blood assays and an MRI (or CT 
scan if MRI is contraindicated). After reviewing all data and in consultation with the 
diagnostic team, dementia experts assign a diagnosis of AD, other forms of dementia, 
MCI, or normal cognition using Alzheimer’s Association/NIA criteria.[61] The 
cognitive test battery consists of tests of naming, word fluency, working and episodic 
verbal and visual memory, and global cognition. Depression and other psychiatric 
symptoms, functional independence, and CG assessment of cognitive and physical 
function are also assessed with interviews and questionnaires. Participants will be 
recruited from the MAC or the ADCC after their routine evaluation and diagnostic 

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classification. New participants recruited from the community will have their intake 
and diagnostic screening performed through the ADCC. If a potential participant has 
been previously given an eligible diagnosis of dementia, they may be given an 
MMSE to confirm they are still within the range of study eligibility rather than a full 
cognitive testing battery and adjudication. If they have previously received a 
consensus diagnosis of MCI, a MoCA may be administered to assess current global 
cognitive function to ensure that they still meet eligibility criteria. If the MoCA 
results in a score that is outside the eligibility range or changes more than 3 points, a 
full cognitive screening will be repeated. Once a diagnosis of dementia is given, it is 
virtually impossible for cognitive status to improve. Requiring people with 
established dementia to complete a full battery of cognitive testing can cause extreme 
distress in the PWD and yet provides little meaningful additional data in the context 
of establishing eligibility for this study. Current cognitive functioning will still be 
assessed with the RBANS pre- and post-intervention. 
4.1 
Inclusion Criteria 
Participants must meet the following inclusion criteria to participate in this study: 
• The person with dementia must be: 
o Age 60-85 years 
o Adjudicated as having mild cognitive impairment or early-stage 
dementia of the predominantly AD, vascular, or mixed AD/vascular 
type within 1 year of beginning the study. If adjudication is older than 
1 year, it may be repeated, or if the person has been diagnosed with 
dementia, an MMSE may be administered to confirm the participant 
falls within the eligibility scores for the study. The adjudication 
process is described more fully in section 6.2.1. 
o English speaking 
o Able to undergo an MRI scan 
o Have a study partner who is around the PWD approximately 10 hours 
per week and is willing to be an active study partner 
o Have a study partner(s) who can regularly accompany the PWD to 
intervention sessions. With approval from the study team, this may be 
a different study partner(s) than the study partner reporting on the 
behavior/mood of the PWD. Different partners may accompany the 
PWD to any given session as long as a partner is present. 
o Not enrolled in an another interventional study for at least 3 months 
prior to beginning this study. 
o Willing to participate in interventions from home using a virtual 
platform if public health concerns exist. Access to internet and an 
appropriate device will be assessed. The study team can provide 
temporary internet access and a loaned device to support the 
participant if they do not have technology access and are willing to use 

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the equipment. 
 
The CG must be: 
o Willing to be an active study partner 
o Spend approximately 10 hours a week with the PWD 
o A caregiver may be younger than the PWD and therefore may have the 
potential to be pregnant. No contraception is necessary for a caregiver 
to participate, as they will not be asked to complete any procedures 
known to present a risk. The MRI will only be completed by the PWD. 
o Willing to participate in interventions from home using a virtual 
platform if public health concerns exist. The study team will provide 
temporary internet access and a loaned device to support the 
participant if they are willing to use the equipment. 
 
4.2 
Exclusion Criteria 
Participants will be excluded if any of the exclusion criteria listed below are present 
at study entry: 
• The PWD has/is: 
o Currently symptomatic or cortical stroke deemed exclusionary by the 
study physician. Persons with subcortical stroke that is resolved or 
largely asymptomatic may be included if found to be appropriate by 
the study physician. Due to the high variability in residual symptoms 
based on factors such as location, size, and time since stroke, these 
will be reviewed on a case-by-case basis by the study physician to 
determine whether these factors may affect study outcomes, aims, or 
integrity. 
o Other causes of dementia, such as Lewy body, fronto-temporal, or 
Parkinsonian dementia 
o Other neurological diseases, such as amyotrophic lateral sclerosis 
(ALS), Parkinson disease, or multiple sclerosis (MS), etc. 
o Any major medical problem that could reasonably affect cognitive or 
brain imaging measures used to determine eligibility or outcomes, or 
severely impact attendance, such as current cancer treatment 
o Taking medication that could negatively influence safety during the 
intervention, such as taking regularly prescribed benzodiazepines  
during study intervention times (see Table 1 below) 
o Any reason for which the study doctor or personal physician feels that 
the intervention is contraindicated for the participant. 

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o Current drug or alcohol use or dependence that, in the opinion of the 
site investigator, would interfere with adherence to study requirements  
o Unwilling to provide consent or assent for study participation 
o Planned extensive travel during the study period 
• The CG has/is: 
o Unable or unwilling to be an active study participant 
o Unwilling to provide consent for study participation 
o Current drug or alcohol use or dependence that, in the opinion of the 
site investigator, would interfere with adherence to study requirements 
o Any major medical problem that could reasonably affect ability to 
attend study and intervention visits, such as cancer treatment 
o Taking medication that could negatively influence safety during the 
intervention, such as taking regularly prescribed benzodiazepines  
during study intervention times (see Table 1 below) 
o Planned extensive travel during the study period without availability of 
an alternate study partner 
The following medications will be considered exclusionary if they are regularly taken 
during intervention times: 
Table 1. List of medications that are exclusionary if given during intervention times 
Benzodiazepines 
• Alprazolam 
(Xanax) 
• Chlordiazepoxide 
(Librium) 
• Clonazepam 
(Klonopin) 
• Diazepam 
(Valium, Diastat) 
• Flurazepam 
(Dalmane) 
• Clorazepate 
(Tranxene) 
• Lorazepam 
(Ativan) 
• Nitrazepam 
(Mogadon) 
• Oxazepam (Serax) 
• Quazepam 
(Doral) 
• Temazepam 
(Restoril) 
• Triazolam 
(Halcion) 
Hypnotics 
• Zolpidem 
(Ambien, 
Zolpimist, 
Intermezzo) 
 
Barbiturates 
• Phenobarbital 
• Pentoparbital 
(Nembutal) 
Anticholinergics 
• Diphenhydramine 
(Benadryl) 
• Hydroxyzine 
(Vistaril) 

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• Doxylamine 
(Unisom) 
 
4.3 
Study Enrollment Procedures  
  
4.3.1 Identification and recruiting of candidates for trial 
  
Identification and recruitment of potential study participants will occur 4 ways: 
• Referral through the WFSM Memory Assessment Clinic (MAC). The 
MAC is an outpatient clinic staffed by the Section on Gerontology and 
Geriatric Medicine that specializes in diagnosis of cognitive complaints in 
older patients. Patients in the MAC undergo a cognitive evaluation that 
includes a neuropsychological test battery, functional status questionnaires 
completed by a proxy, and a history and physical by a board-certified 
geriatrician. Persons without recent imaging or blood work to rule out 
reversible causes of cognitive impairment receive standard blood assays 
(including thyroid hormone and vitamin B12 levels) and an MRI (or CT scan 
if MRI is contraindicated). After reviewing all data and in consultation with 
the diagnostic team, a diagnosis is made using current criteria. Of the 400 
older adults seen annually in the MAC, about 160 are diagnosed with 
dementia (all causes), 200 with MCI, and 40 are judged to be unimpaired. The 
MAC neuropsychological test battery consists of the Mini Mental State Exam, 
Digit Symbol Coding, Category Fluency-Animals, Rey Auditory Verbal 
Learning Test, Clock Drawing, Rey-Osterreith Complex Figure, Logical 
Memory I and II, Trail Making Test, and Boston Naming Test. In addition, the 
Geriatric Depression Scale, Geriatric Anxiety Scale, Katz Activities of Daily 
Living Scale, the Lawton Instrumental ADL Scale and the Neuropsychiatric 
Inventory Questionnaire are collected.  
Participants will be recruited from the MAC after their routine evaluation and 
diagnostic classification. MAC staff will provide a list of patients who have 
been adjudicated as having MCI or early-stage dementia believed to be 
primarily of the Alzheimer’s, vascular, or mixed Alzheimer’s and vascular 
type. Study staff will review the information provided and contact participants 
who may qualify for the study to invite them to participate. An Institutional 
Review Board (IRB)-approved letter will be sent to potential participants to 
briefly inform them about the study. The letter will be followed by a phone 
call inviting them to participate. Those who are interested in participating will 
be screened using an IRB-approved telephone screening questionnaire to 
assess eligibility.  
• Referral through the Alzheimer’s Disease Coordinating Center (ADCC). 
Cognitive assessments through the MAC and ADCC are highly overlapping 
and will ensure diagnostic consistency. The ADCC neuropsychological test 
battery is based on the Uniform Data Set (version 3) from the National 
Alzheimer’s Coordinating Center (NACC). It is designed to test multiple 
aspects of cognitive function and typically includes the Montreal Cognitive 

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Assessment (MoCA), Story Recall, Benson Complex Figure, Trail Making 
Test, Category Fluency, Phonemic Fluency, Number Span (forward and 
backward). In addition, function, behavior, and mood are assessed through the 
Clinical Dementia Rating Scale (CDR), ADL checklist, IADL checklist, GDS, 
and NPI. Participants referred from the ADCC have had thyroid hormone and 
vitamin B12 levels measured.  
ADCC staff will provide a list of patients who have been adjudicated as 
having MCI or early-stage dementia believed to be primarily of the 
Alzheimer’s type after adjudication or from existing databases of participants 
who are enrolled in non-interventional studies or who have completed an 
interventional study 3 months or more in the past. Study staff will review the 
information provided and contact participants who may qualify for the study 
to invite them to participate. An IRB-approved letter will be sent to potential 
participants to briefly inform them about the study. The letter will be followed 
by a phone call inviting them to participate. Those who are interested in 
participating will be screened using an IRB-approved telephone screening 
questionnaire to assess eligibility.  
• Referral from other clinics. Participants may be referred from other clinics 
as long as the adjudication procedure is similar to that used in the MAC or 
ADCC. These participants must have an appropriate diagnosis after 
assessments including a cognitive battery, bloodwork, exam by a physician, 
and neuroimaging. 
• Referral from the community. Participants who are not part of the MAC or 
ADCC or who have not been diagnosed with a memory concern may also 
wish to volunteer for the study. Community awareness of the study may occur 
through public talks, community contacts, mention in newsletters from the 
Sticht Center on Aging, press coverage, or IRB-approved advertising, such as 
fliers. If someone from the community wishes to be part of the study, they will 
first be adjudicated through the ADCC. 
• If a participant has completed a full approved cognitive assessment as 
described above and received a diagnosis of dementia, cognitive eligibility 
may be assessed by confirming the diagnosis with an MMSE for individuals 
with a dementia diagnosis or MoCA for individuals with an MCI diagnosis 
rather than re-administration of the full cognitive testing battery.  
4.3.2 Documentation of ineligibility or non-participation 
People who decline to participate will be asked to provide information about reasons 
for declining. Information from the telephone screening instrument will be data entered 
into REDCap for the purpose of assessing rate of successful recruitment and barriers to 
participation, as well as to prevent re-contacting an individual if they are referred more 
than once. Ability to download identifying information such as name, address, and 
phone number will be restricted to the PI in REDCap. 
People who qualify for the study, but choose not to participate, or who drop out after 
randomization will be asked to provide reasons for non-participation. This information 

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will be recorded in the study log and will be data entered into REDCap for the purposes 
of assessing barriers to participation and reporting on study retention. 
4.3.3 Consent procedures 
Signed informed consent will be obtained from each subject. The primary outcome for 
this study is QoL in the PWD. However, the CG will be an active participant. 
Important data will be collected through the CG about the PWD, and other important 
data will be collected about the CG for the purpose of testing for alternate hypotheses 
and controlling for factors such as caregiver personality and mood that might influence 
the CG’s reports about the PWD. Therefore, written informed consent will be obtained 
from each PWD and CG. The CG will report important information about the PWD 
including recent cognitive symptoms and mood, as well as medical history for 
inclusion/exclusion purposes and safety of testing procedures such as MRI. If the CG is 
incapable of reliably reporting medical history, this information may be collected from 
a family member via telephone.   
The informed consent process will follow the procedures of the WFU IRB.  The study 
interviewers will explain the purpose, methods and extent of the study to prospective 
participants.  The potential participant is asked to read the informed consent form and 
ask questions.  The form is written in simple easy to understand language.  We require 
study staff to review all of the key aspects of the study verbally with the potential 
participants. Staff then question potential participants to ascertain whether they have 
understood the information.  Potential participants who are illiterate or have impaired 
vision must have the consent read to them, followed by review of the checklist, 
opportunity for questions, and discussion. Because participants in this study are at early 
stages of memory loss, some PWD may have a legally authorized representative while 
others will not. We will request that the CG be present during consent regardless of 
whether they are a legally authorized representative or not to make sure the interests of 
the PWD are protected. The CG will be asked to sign the consent form to document 
their presence during consent even if they are not a LAR. Consent may be administered 
virtually following approved IRB protocols if public health concerns exist. 
A copy of the signed and dated consent form will be given to participants, and the 
original document will be placed in subjects’ individual study files, which will be 
stored in a secure location. In compliance with the Health Insurance Portability and 
Accountability Act (HIPAA) and the Standards for Privacy of Individually Identifiable 
Health Information of the Department of Health and Human Services, we will access 
personal health information only after obtaining informed consent. 
4.3.4 Randomization procedure 
After completing the second study visit, participants will be randomized to their study 
condition (Movement Group, Movement Alone, Social Group, No Contact) through a 
computerized randomization scheme with blocking stratified by gender. Recruitment 
will occur in phases. Randomization will be blocked in blocks of 32 that each 
correspond with a wave of data collection; each block will randomize 4-10 dyads to 
each of the 4 study groups.   

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5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
The study will have 4 arms: Movement Group (MG), Movement Alone (MA), Social 
Group (SG), and No Contact (NC) control.  
Dosing schedule. The aim of all 3 intervention arms (MG, MA, SG) is for 
participants to meet for 1-hour sessions 2 times a week for 12 weeks (24 sessions). 
Participants will have the option of completing the 24 sessions within 13 weeks to 
allow for make-up days for missed classes due to illness, weather events, or other 
conflicts. All efforts will be made to accomplish the full 24 sessions in 12 weeks. An 
unblinded staff member will contact participants regularly to remind them to attend.  
Group interventions will occur in waves. In order to allow adequate resources for pre- 
and post-intervention testing with a wave study design, entry into MG and SG arms 
will be staggered across a month if needed.  Slightly staggering group intervention 
entry (and therefore intervention completion) will prevent a situation where follow-up 
testing might be delayed due to limitations on scanner time or coordinator effort.   To 
accommodate staggering of group intervention entry, group interventions may span 
17 weeks in total. Follow-up testing for each dyad will take place between days 0-7 
and again between days 1-21 after the last intervention session. Dyads will be asked 
to continue the intervention to conclusion to maintain a stable group structure.  
Location. All interventions will take place in spaces that are safe, well-lit, have 
convenient parking, and are accessible for a range of mobility. The spaces planned 
include a local dance studio in close proximity to WFSM (Academy of Dance Arts, 
1425 West First Street,Winston -Salem, NC  27101), a space downtown owned by 
Wake Forest University (WFU Brookstown Campus, 200 Brookstown Avenue, Suite 
302, Winston-Salem, NC  27101), space on the WFSM campus (Piedmont Plaza II, 
2000 West First Street, Winston-Salem, NC, 27104), and Old Town Recreation 
Center, 4550 Shattalon Dr, Winston-Salem, NC 27106. Additional spaces may be 
added as needed to ensure the convenience and safety of participants. For dance 
interventions, participants will be given options of spaces to dance in that are free 
from obstacles, have a sturdy chair(s) with no arms, and a means for playing music or 
recordings of dance instructors.  
 
As of March 2020, all in person visits were suspended due to COVID-19. A pilot 
study was conducted to validate the administration of the intervention visits via video 
conferencing software. Dependent upon federal, state, and local recommendations, all 
intervention visits may be conducted remotely. To ensure safety of all participants, 
the home environment will be assessed for safety in the same way public spaces are 
assessed. Study staff will confirm there is enough open, uncluttered space where 
movement sessions could safely take place in the home. If appropriate chairs are not 
present, staff will provide them for the duration of the interventions. 
 
Movement Group. The MG will participate in 1-hour group improvisational dance 
[62, 63] lessons 2x/week for 12 weeks. We have published the dance method and 

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theory,[62] and describe it briefly here. Improvisational dance classes are grounded in 
4 principles that shape the tone of the class and result in a sense of social belonging: 
non-judgment, non-competitiveness, curiosity, and playfulness. The following 
training strategies are used to maintain: active imagination, variability, and pacing.  
• Active imagination. Working with imagery is crucial in improvisatory practice.  
Verbal auditory cues are used to create movement scenarios that cue or activate the 
motor imagination. Verbal auditory cueing takes primacy over rhythmic entrainment 
to music, although the music itself may be used as an improvisatory cue. The teacher 
calls the cue, may demonstrate an optional response, and asks participants to join in 
with their own gestural inventions. As an example, students might be prompted 
during the seated warm-up to recreate a beach scene. Verbal auditory cues direct 
motor imagination by using rich language to act out a beach scenario - laying down 
beach blankets, putting on sunscreen, opening a picnic basket, setting out lunch on a 
blanket, running into the ocean, avoiding the shark swimming towards them, etc.  
• Variability. The improvisational method does not aim to learn a specific movement 
pattern and habituate to it. Cues are delivered quickly, one after another.[64] Within 
an average of two minutes, tasks requiring quicker decision-making are introduced. 
Physical challenges are advanced by dual- and multi-tasking, such as being asked to 
direct traffic with the right side of the body while picking apples with the left. 
• Pacing. This is the rate at which new movement prompts are presented. Quick 
changes in pace avoid defaulting to habitual responses, thereby facilitating new 
movement options. Participants cannot rely on copying another, memory, or 
anticipation to address the motor problem. Verbal cues might be delivered in a rapid-
fire manner, for example, to keep participants from reflecting on movement choices, 
changing their minds, or becoming embarrassed or dissatisfied with the choice made.  
Use of music. Music is used in different ways in the class. The playlist is random and 
variable; it may be unrelated to movement instruction and merely ambient.  At other 
times, the music may be an improvisational cue. As examples, students may be asked 
to dance what comes to their minds listening to Otis Redding’s “(Sittin’ on) The Dock 
of the Bay” and then variations are cued from that initial movement, or “play” an 
instrument they can hear in a complex piece of classical or jazz music. Sometimes, 
participants themselves create movement through vocalizing or body-based 
percussive actions. Portions of the class also happen in silence. Unpublished video 
analysis of previous studies shows that participants are more likely to improvise than 
follow (entrain to) the beat of any music played. 
Overall class structure. The general class structure has four phases. These include: 
(1) group warm-up in chairs positioned in a circle, (2) standing barre with solo- and 
partnering exercises, (3) moving as a group through free space (with and without a 
partner), and (4) recuperation and rest. If participants are unable for any reason to 
perform exercises at the barre or move through free space, all exercises can be 
adapted for sitting. The choice to stand or walk is always self-selected by the 
participant. In fact, this adaptation is common in the weekly community class that 
Ms. Soriano has taught for 5 years. Similar exercises may appear within each phase, 
creating a progression of motor skills, but the class series does not build 

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incrementally. Recuperative phases are essential to rest and recover metabolically and 
cognitively. These movements are slower, simpler, and often more familiar (e.g., 
seated hamstring stretch). The overall class structure remains the same when the class 
is presented virtually. However, group movements through free space will be adapted 
as needed for the home environment.  
Movement Alone. The MA intervention is designed to capture the same dance 
movement and auditory stimuli as the group class without social interaction. 
Recordings of the dance instructors will be played that include the same range of 
prompts presented to group classes. This will ensure participants hear comparable 
music and receive comparable verbal auditory cues to prompt dance movements that 
students in the group class will hear without interacting with other people. 
Participants will be asked to follow the same schedule as participants in the MG arm 
and complete 2 one-hour dance sessions each week. A sample of each subjects’ 
individual dance sessions will be video recorded.  This recording will yield data that a 
trained student or staff member can view and code to document movement fidelity 
(e.g., that the person has responded to the dance prompts and for the purpose of 
comparing the amount of quality of movements that occur in individual vs. group 
dance settings). Study staff will check participants into the rooms and ensure that all 
equipment is working.  
Social Group. As outlined above, four principles guide the overall tone of group 
dance class: non-judgment, non-competitiveness, curiosity, and playfulness. It is 
important the social intervention group recapitulates aspects of fun and playfulness as 
in the MG. Unstructured survey feedback about the dance group included “laughing”, 
“made me laugh and have fun”, and “the chance to be more creative and 
spontaneous.” In our pilot study, the individual item on the QOL-AD that increased 
most in PWD who participated in the dance group was ‘Ability to do things for fun’. 
A traditional education group, as is a control in many exercise intervention studies, 
would likely not provide such stimulus. Therefore, the social group will consist of 
improvisational party games to foster curiosity and playfulness, use imagery, and 
encourage non-judgment. Games that may be used include ‘Balderdash’, ‘Wise and 
Otherwise’, ‘Pictionary’, and ‘Tell Me A Story’ cards. These games will also use the 
same core strategies as the MG. Games will be varied within an hour-long session to 
incorporate pacing and variability into the social group. The social group will be led 
by the same instructors who lead the MG to control for effects of personality of the 
group leader. Social group games have been adapted as needed for use in a virtual 
environment. As examples, rather than having ‘Tell Me A Story’ cards dealt onto a 
shared table, the cards are scanned in and presented on a powerpoint slide. If a game 
requires physical materials that a participant may not have (for example, a white 
board), the materials may be purchased by the study team, appropriately sanitized, 
and delivered to participants prior to group sessions following appropriate health 
procedures.   
Guidelines for Use of Appropriate Supportive Care. All study and intervention 
staff will be trained in CPR. Interventions will most often occur off the medical 
school campus. In the event of any emergency that requires medical attention during 
an intervention, regardless of whether it is related to the intervention, staff will be 

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instructed to call 911. The participant must agree to call 911 if they are conscious; 
medical treatment cannot be forced on a participant. This protocol also applies to 
virtual visits if a staff member observes a medical event that occurs in the home 
during a study intervention. Study visits will take place on the WFSM hospital 
campus. For a visit that occurs on the WFSM hospital campus, staff will be instructed 
to call the internal emergency number, 6-9111. All appropriate reporting procedures 
described in the DSMP will be followed after any adverse event. 
 
5.2 
Handling of Study Interventions  
Completion of Study Intervention Accountability Records. Study staff and 
intervention staff will be responsible for documenting attendance. Each participant 
will have an attendance form where study staff will note whether or not they attended 
the intervention that day. In addition, for dance and social groups, the instructor will 
note a qualitative rating of engagement with the group on a Likert scale from 0-5. 
Study staff will document attendance of MA participants when they check them into 
their movement room for in-person intervention or when they log the participant into 
the videoconferencing software for virtual intervention. There will be a notes section 
for all participants where any other relevant observations can be recorded. When a 
session is video recorded, study staff will be responsible for archiving the video 
within 24 hours of collection and deleting it from the recording device. For 
participants completing the interventions virtually, on the dates when recording 
occurs, participants will be asked Likert-style questions about their perceived 
connection to the group, perceived connection to the instructor, enjoyment, and ease 
of use of technology. 
Mechanisms for blinding study interventions. During screening and baseline visits, 
e.g., prior to randomization, study staff will be blinded to the randomization scheme. 
Therefore, group assignment will not be known during testing or assignment to 
groups. One primary study staff member and one backup team member will be 
assigned to be unblinded after baseline visits for the purposes of notifying participants 
of their study arm, coordinating intervention visits as needed, and making reminder 
calls. Intervention staff will not be performing any research assessments of 
participants and will not be blinded to group assignment.  
 
Delivering Virtual Interventions 
The process for delivering virtual interventions will be similar across intervention 
arms. Participants will be sent written materials and a video demonstrating how to use 
the videoconferencing software on their device. Separate instructions have been 
prepared for a range of brands, internet browsers, and devices. Prior to beginning any 
virtual intervention, staff trained in using the videoconferencing software will have a 
call with the PWD and CG to walk them through correctly accessing and configuring 
the videoconferencing software. This check will include: 
• Ensuring video and sound connectivity 
• Helping the participants locate a safe and appropriate space for the 

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intervention 
• Helping the participants adjust the video and audio levels so that they can be 
seen and heard and so that they can see and hear the staff member 
• Ensuring the participants know how to change relevant settings within the 
software, such as the view of the group 
Prior to the intervention date, participants will be sent a secure link to the session. 
Staff will log on approximately 15 minutes ahead of the scheduled session time. A 
technical support team member will be present to address any technical issues that 
arise during the session. This team member will have the telephone contact 
information for all participants so they can be reached if their videoconferencing is 
not working correctly. A moderator will be present to greet participants as they enter 
the room, foster conversation, and give study-relevant reminders. An instructor will 
be present to lead the group. These roles will usually be filled by three separate 
people. However, if necessary, the role of technical support staff and moderator may 
be filled by one person. This format mimics the in-person format for group 
interventions, where a study team member is present to check participants in, a 
volunteer is usually present to provide additional support as needed, and the instructor 
is present to lead the group. 
Delivering the Movement Group Intervention. Trained dance instructors will be 
responsible for administering the MG intervention and may be accompanied by 
assistants. Professor Soriano, the Co-PI, will be responsible for training any other 
dance instructors in the method they will be using. The instructor arrives prior to the 
class to arrange the chairs in a circle and prepare the music. Participants in the 
intervention will arrive at the specified location for class. When they enter the dance 
room, they will be greeted by the dance instructor and invited to sit and join the 
group. After the group has arrived, the instructor will begin the class as described 
above in section 5.1. Upon completion of the class, the instructor will immediately 
complete attendance sheets. 
For virtual sessions, participants will receive a secure link to the movement session. 
Participants will be allowed to socialize and interact as they would in person until 
everyone arrives and the instructor is ready to begin the movement class. During the 
pilot testing of the virtual intervention, structured social interactions were piloted 
along with unstructured chatting. While some people enjoyed the structured 
interactions, the overall preference was for unstructured interactions. All other aspects 
of the protocol will remain the same – the instructor will greet the class by name and 
will complete attendance sheets and engagement ratings immediately after the class. 
Delivering the Social Group Intervention. The same dance instructors who 
administer the MG will also administer the SG to control for effects of instructor 
personality. The instructor arrives prior to the class to ensure the room arrangement is 
correct and any supplies needed for the class are prepared. Upon completion of the 
class, the instructor will immediately complete attendance sheets. 
For virtual sessions, participants will receive a secure link to the social group session. 
Participants will be allowed to socialize and interact as they would in person until 

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everyone arrives and the instructor is ready to begin the class. 
Delivering the Movement Alone Intervention. Participants will contact study staff 
to reserve two 1-hour long blocks each week at an available site. Study staff will 
arrive prior to participants to make sure all equipment for presentation and recording 
is operating. Study staff will be present to check participants into the room, monitor 
for any adverse events, and document attendance. After the MA session is complete, 
study staff are responsible for transferring files if video has been taken to assess 
treatment fidelity, neatening the space, and locking any doors if necessary. 
For virtual sessions, participants will receive a secure link to the virtual movement 
session. Study staff will greet them and will administer the pre-recorded classes and 
music through the videoconferencing software. As in the in-person intervention, the 
study staff will monitor for adverse events, document attendance, video record 
sessions, and transfer files appropriately. 
Delivering the No Contact Control Arm. Participants in the no-contact control arm 
will be contacted by phone at least once a month by an unblinded study staff member. 
During this phone call, they will be asked a set of questions about their current health 
and lifestyle to assess whether they have had any major life events or have made any 
substantial lifestyle changes. Participants will be reminded to maintain their usual 
lifestyle.  
5.3 
Concomitant Interventions  
5.3.1 Allowed Interventions 
Because movement classes can be completed seated, all movements are self-selected 
and voluntary, and the class does not require any strenuous cardiovascular 
engagement, medical limitations for participation are not extensive. Participants 
should continue any medications they are taking at enrollment (e.g., that are not 
exclusions for the study). Participants should always take rescue medications as 
needed. If a participant changes medications that will affect study outcomes or safety, 
they should inform study staff. Participants will be queried monthly about changes in 
health status during routine reminder phone calls and this will be documented. 
5.3.2 Required Interventions 
Participants are required to participate in the intervention arm to which they are 
randomized and to notify study staff of any major changes in their lifestyle or health 
status that might affect their safety to participate or study outcomes. 
5.3.3 Prohibited Interventions 
Participants are prohibited from participating in other interventional studies while 
enrolled in this study. They may participate in observational studies. All participants 
are requested not to begin any major changes in physical activity or diet outside of the 
study intervention. Participants are prohibited from participating if they are taking 
any medications during study intervention times that may interfere with their 
alertness or balance (e.g., benzodiazepines).  

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5.4 
Adherence Assessment  
Study and intervention staff will be responsible for documenting attendance. Each 
participant will have an attendance form where staff will note whether or not they 
attended the intervention. For dance and social groups, the instructor will note a 
qualitative rating of engagement with the group on a Likert scale from 0-5. Study 
staff will document attendance of MA participants upon check in. There will be a 
notes section for all participants where any other relevant observations can be 
recorded. Participants will also complete their own attendance sheet to encourage 
self-awareness of attendance. Good adherence will be defined as attending 
approximately 85% or greater of intervention sessions (that is, 20 of 24 sessions).  
6. STUDY PROCEDURES  

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6.1 
Schedule of Evaluations 
Table 2. Assessments administered to PWD (including allowable windows) 
Assessment 
Source Data Type 
Baseline 1 
w/in 2 mos of phone 
screen and 14 weeks 
of intervention start 
Baseline 2 
w/in 6 wks of 
intervention start 
Follow-up 1 
0-7 days after 
intervention 
completion 
Follow up 2 
1-21 days after 
intervention 
completion 
Alternative Uses Task  
Paper 
 
X 
 
X 
Apathy Evaluation Scale 
Paper 
 
X 
X 
 
Blood draw - biomarkers  
Lab Report 
X 
 
X 
 
Consent 
Paper 
X 
 
 
 
Contact Form 
Paper 
X 
 
 
 
Demographics 
Paper 
X 
 
 
 
Expanded Short Physical Performance Battery 
Paper 
X 
 
 
X 
Falls Efficacy Scale  
Paper 
 
X 
X 
 
Fullerton Advanced Balance Scale 
Paper 
X 
 
X 
 
Gait Speed/Variability 
Electronic 
X 
 
 
X 
Geriatric Anxiety Scale 
Paper 
 
X 
X 
 
Geriatric Depression Scale 
Paper 
 
X 
X 
 
Medical History/RX 
Paper 
X 
 
 
 
MoCA 
Paper 
X 
 
 
X 
MRI 
Electronic 
 
X 
X 
 
Multisensory Reaction Time  
Electronic 
 
X 
 
X 
Philadelphia Mindfulness Scale 
Paper 
X 
 
 
X 
Postural Sway 
Electronic 
X 
 
 
X 
QOL-AD 
Paper 
X 
 
X 
 
RBANS 
Paper 
 
X 
 
X 
Study Expectations 
Paper 
X 
 
 
 
Timed Up and Go  
Paper 
X 
 
 
X 

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Table 3. Assessments administered to CG 
Assessment 
Source  
Data Type 
Baseline 1 
w/in 2 mos of phone 
screen & 14 wks of 
intervention start 
Baseline 2 
w/in 6 wks of starting 
intervention 
Follow-up 1 
0-7 days after 
intervention completion 
Follow-up 2 
1-21 days after 
intervention 
completion 
Alternative Uses Task  
Paper 
 
X 
X 
 
Apathy Evaluation Scale (AES) 
Paper 
 
X 
X 
 
Blood draw - biomarkers 
Lab Report 
X 
 
X 
 
Consent 
Paper 
X 
 
 
 
Contact Form 
Paper 
X 
 
 
 
Demographics  
Paper 
X 
 
 
 
Expanded Short Physical Performance Battery 
Paper 
X 
 
X 
 
Falls Efficacy Scale  
Paper 
 
X 
X 
 
Fullerton Advanced Balance Scale 
Paper 
X 
 
X 
 
Gait Speed/Variability 
Electronic 
X 
 
X 
 
Geriatric Anxiety Scale 
Paper 
 
X 
X 
 
Geriatric Depression Scale 
Paper 
 
X 
X 
 
Medical History/RX 
Paper 
X 
 
 
 
MoCA 
Paper 
X 
 
 
X 
Multisensory Reaction Time  
Electronic 
 
X 
 
X 
NEO-FFI 
Paper 
 
X 
 
 
NPI-Q 
Paper 
 
X 
X 
 
Philadelphia Mindfulness Scale 
Paper 
X 
 
 
X 
Postural Sway 
Electronic 
X 
 
X 
 
RBANS 
Paper 
 
X 
 
X 
SF-36 
Paper 
 
X 
X 
 
Study Expectations 
Paper 
X 
 
 
 
Timed Up and Go  
Paper 
X 
 
 
X 
Zarit Caregiver Burden Scale 
Paper 
 
X 
X 
 

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6.2 
Description of Evaluations  
6.2.1 Screening Evaluation 
Consenting Procedure 
Telephone screening will take place after verbal informed consent using an IRB-
approved script and form. Participants referred from the MAC or ADCC will receive 
an IRB-approved letter in the mail to let them know that study staff plan to contact 
them by phone about study participation. Study staff will read an IRB-approved 
telephone screening script and form, and explain that information from the phone 
screening will be kept for purposes of understanding barriers to study participation 
and to prevent duplicate contacts.  
Written, informed consent will be collected from participants referred from the MAC 
or ADCC who qualify after telephone screening at the outset of Baseline Visit 1 
(BV1). Participants from the community who qualify after telephone screening will 
provide written, informed consent at the outset of the screening visit (SV). Consent 
may be administered virtually following IRB-approved protocols if public health 
concerns exist. 
Outcomes for the PWD are the primary target for this study. However, the CG will be 
an active participant. Important data will be collected through the CG about the PWD. 
Other important data will be collected about the CG for the purpose of controlling for 
factors that might influence the CG’s reports about the PWD and testing for alternate 
hypotheses. Therefore, written informed consent will be obtained from each PWD 
and CG.  The PWD and CG have separate consent forms, as study procedures differ. 
For example, the PWD will receive an MRI scan and the CG will not. If there are 
multiple caregivers involved in the life of the PWD, a primary caregiver will be 
identified to report on the mood and behavior of the PWD in baseline and follow-up 
study visits. If needed, other reliable, involved caregivers may accompany the PWD 
to intervention sessions. This meets the scientific goals of the study by providing data 
on the CG reporting on the mood and behavior of the PWD, and meets the goals of 
the intervention by including a reliable, involved CG in the intervention. 
The informed consent process will follow the procedures of the WFU IRB.  Study 
staff will explain the purpose, methods and extent of the study to prospective 
participants.  The potential participant is asked to read the informed consent form and 
ask questions.  The form is written in simple easy to understand language.  We 
require study staff to review all of the key aspects of the study verbally with the 
potential participants. Staff then question potential participants to ascertain whether 
they have understood the information.  All study staff will be trained to administer the 
consent including practicing in front of a lead study coordinator and/or the PI. A copy 
of the signed and dated consent form will be given to participants, and the original 
document will be placed in subjects’ individual study files, which will be stored in a 
secure location. Consenting will be done with both the CG and PWD present. 
Because this study targets MCI and early-stage dementia, the CG may be a legally 
authorized representative for some PWD while others will not yet have a legally 
authorized representative. In all cases, the CG will be asked to co-sign the consent 

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form for the PWD, either as a study partner or a legal representative to ensure that the 
best interests of the PWD are protected. 
Documentation of signed consent will be kept by 1) the original consent form, 2) a 
documentation of consent form that includes the name of the participant, and 3) a 
documentation of consent form with study number only to be kept with the file in 
long-term storage. 
Screening 
Telephone Screening. All participants will be screened over the telephone prior to 
any in-person screening to reduce burden on prospective participants and study staff 
by eliminating potential participants with known exclusions. Study staff will use an 
IRB-approved script and telephone screening questionnaire. Questions will be asked 
of both the CG and PWD. Follow-up phone calls will be made if needed to speak 
with both the CG and PWD. Prospective participants volunteering from the 
community will be asked to complete the Telephone Interview for Cognitive Status 
(TICS) as a brief cognitive screening tool. Based on published cutoff scores, a TICS 
score between 34 and 15 will qualify someone to participate in the full cognitive 
screening. Phone screening will be completed no more than 2 months before the first 
baseline testing visit. 
Adjudication of Cognitive Status. The PWD enrolled in the study is required to 
meet criteria for Mild Cognitive Impairment or early-stage dementia believed to be 
either Alzheimer’s disease, vascular, or mixed dementia. Participants referred through 
the MAC or ADCC will have already completed a battery of cognitive, functional, 
and medical tests and had cognitive status adjudicated by consensus within the past 
year.  
Potential participants who previously completed full cognitive testing, but whose 
testing is outside of the 1 year time window may be asked to complete a global 
cognitive screen only (MMSE for those diagnosed with dementia, MoCA for those 
with MCI). If the results of the global test are within inclusion ranges and staging 
guidelines, participants will be deemed eligible for full study inclusion. In the case of 
individuals with MCI, if their score changes more than 3 points or is outside the 
eligibility criteria, a full cognitive screening will be performed.  
 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
When participants have completed the baseline visits and have been randomized, they 
will be considered to be enrolled in the study.  
Baseline Assessments 
Participants who have passed the telephone screening and have been adjudicated to 
have an appropriate cognitive status will be invited to complete two baseline visits. 
Participants who were adjudicated through the MAC or ADCC will complete their 

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written, informed consent at the first baseline visit, as well as complete a thorough 
medication review and medical history. If an exclusionary medication or diagnosis is 
disclosed face-to-face that was not reported over the phone, the study visit will be 
ended and the participant will not be enrolled in the study. Baseline assessments will 
be completed within the 6 weeks prior to intervention initiation. The exact ordering of 
tasks may vary to accommodate scheduling needs. For instance, the MRI scan may 
take place on a third visit if that is preferred by the participant. Any questionnaires 
administered, such as health history, quality of life, depression and anxiety 
questionnaires, etc. may be administered via telephone or videoconferencing if 
needed in response to the current public health situation. Virtual administration of 
these measures may be used to limit participant time in a clinical setting. If in-person 
study visits are completely suspended in response to a public health situation, as 
much data as possible will be collected virtually as close as possible to the 
appropriate timepoint. If the virtual intervention is able to continue the full duration 
as expected, the primary outcome (QOL-AD) will be collected per protocol 0-7 days 
after completing the intervention and any other measures possible to collect will be 
collected with the timeframe specified per protocol. Because the intervention is 
virtual, we do not anticipate it will have to be suspended. However, if the intervention 
is suspended for any reason and is unable to resume, all measures possible will be 
collected per protocol timeframe treating the day of determination that the study is 
unable to resume as day 0. 
The following assessments of the PWD will take place during Baseline Visit 1 as 
outlined in Table 2 in section 6.1 after IRB-approved, written informed consent:  
• Fasting blood draw. Planned lab tests of the blood collected in the morning 
after fasting will include a basic metabolic panel (BMP), complete blood 
count (CBC), fibrinogen, total cholesterol, HDL, triglycerides, albumin, 
DHEA sulfate, insulin, hemoglobin A1c, cortisol, and C-reactive protein 
(CRP). 
• Quality of Life (QoL-AD). We will measure QoL in PWD using the QOL-
AD, a measure of QoL validated in people with dementia who had Mini-
Mental State Exam (MMSE) scores as low as 10.[65-67]  
• Fullerton Advanced Balance Scale (FABS). Measures balance using 10 
different performance-based tests.[68] 
• Postural sway during quiet stance will be assessed from Center-of-Pressure 
(COP) trajectory data collected at 100 Hz using an Advanced Mechanical 
Technology Incorporated (AMTI) AccuSway biomechanics force platform.  
COP data will be collected in a series of 10 30-second trials.  Additionally, we 
will complete 5 30-second trials on a foam mat placed on top of the force 
platform. Statistical mechanics techniques will be applied to the 
anteroposterior and mediolateral [69-74] directions of the COP trajectories; 
studies have linked these to clinical measures of balance performance and/or 
fall risk.  
• Gait speed and variability will be assessed over 4m 4 times at usual pace 
and 4 times at fast pace using an instrumented mat (GAITRite System), which 

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provides data on average step and stride length, initial and terminal double 
support time, and variability in these measures. We will also ask participants 
to walk at usual pace over the instrumented mat while performing a cognitive 
task, with no instructions on which task to prioritize.[75, 76]   
• Expanded Short Physical Performance Battery (eSPPB).  The SPPB[30] is 
a brief test of global mobility function with excellent test-retest and inter-
examiner reliability;[77] is sensitive to change;[78] is safe, and is a robust 
predictor of future physical disability and death.[30] To avoid ceiling effects, 
we will use an expanded version (eSPPB)[79] . The resulting score is 
normally distributed, continuous, and shows greater sensitivity to change.[80]  
• Timed Up and Go (TUG)[81]. Measures the time for a participant to rise 
from a chair, walk 3m, turn, walk back to the chair, and sit. The TUG has 
been shown to have good specificity and sensitivity for identifying older 
adults at risk of falling. Participants will also complete the cognitive TUG 
(cTUG) and manual TUG (mTUG). 
• Philadelphia Mindfulness Scale (PHLMS). [82] Unstructured written 
feedback from a previous pilot of this improvisational movement method in 
community-dwelling older adults suggested that participants showed greater 
body awareness of self and others, as well as less judgment of self and others. 
Therefore, we chose to include a mindfulness scale that specifically targets 
attentional awareness and judgment. 
• Montreal Cognitive Assessment (MoCA) a test of global cognition 
 
The following assessments completed by the CG will take place during Baseline Visit 
1 (BV1): 
• Fullerton Advanced Balance Scale 
• Philadelphia Mindfulness Scale 
• Postural Sway 
• Gait Speed and Variability 
• Expanded Short Physical Performance Battery 
• Timed Up and Go 
• Montreal Cognitive Assessment (MoCA)  
 
The following assessments of the PWD will take place during Baseline Visit 2 (BV2):  
• Abbreviated cognitive battery. We do not hypothesize that dance affects the 
underlying disease course, and therefore do not expect improved cognition. 
However, previous work has shown better cognition in older social 
dancers[13, 83] and improved cognition in response to dance in healthy 
elderly.[84, 85] To control for any potential relationships between study 

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interventions and cognition, an abbreviated cognitive battery, the Repeatable 
Battery for Neuropsychological Status (RBANS) will be administered to CG 
in Baseline Visit 2 and PWD and CG in Follow-up Visit 2. The RBANS takes 
approximately 30 minutes to administer, tests multiple cognitive domains, 
includes parallel forms for repeated test administration, and has been used in 
multiple clinical trials.[86, 87]  
• Falls Efficacy Scale International (FES). Falls Efficacy Scale 
International (FES-I)[88]. A 16-item scale to assess fear of falling where 
higher scores reflect a higher fear and risk of falling. 
• Geriatric Depression Scale (GDS) and Geriatric Anxiety Scale (GAS).[89] 
PWD be asked to complete brief screening tools to assess depression and 
anxiety.   
• Apathy Evaluation Scale (AES). A short form will be used that has been 
modified for use with PWD.[90] 
• Alternative Uses Task (AUT).[91] A commonly used test of divergent 
thinking that asks participants to list as many uses as possible for common 
objects. The total number of items generated is the outcome of interest here. 
• Multisensory Reaction Time.[92] A brief test of reaction time that includes 
reaction time to visual, auditory and audiovisual stimuli. 
MRI scan of brain. The primary outcome of interest is graph theory-derived 
measures of network structure calculated on fMRI images. PWD will complete 1-
hour MRI scans in visits 2 and 3 that will include images needed for primary 
outcomes (T1-weighted structural image, fMRI images) and images needed for 
potential alternate hypotheses (e.g., FLAIR images to assess white matter 
hyperintensity burden, related to gait in aging). The following assessments completed 
by the CG will take place during Baseline Visit 2 (BV2):  
• Quality of Life (SF-36). We will measure QoL in CG using the Short Form-
36 (SF-36).[93, 94] 
• Neuropsychiatric Inventory Questionnaire (NPI-Q). The NPI is designed 
to assess neuropsychiatric symptoms in PWD with the CG.[95] The NPI-Q 
includes questions about 12 domains of symptoms: delusions, hallucinations, 
agitation/aggression, depression, anxiety, elation/ euphoria, apathy, 
disinhibition, irritability, aberrant motor activity, sleep, and eating.  
• NEO Five Factor Inventory (NEO-FFI).[96] CG reports can be influenced 
by personality.[97] Therefore, CGs will complete a personality measure that 
categorizes personality on: emotionality/ neuroticism, extraversion, openness 
to new experiences, agreeableness, and conscientiousness.  
• Zarit Caregiver Burden Scale (Zarit CBS) [98]. A 21-item self-report scale 
where caregivers rate items describing burdensome or stressful situations as 
occurring 0=Never to 4=Nearly Always. Total scores are categorized as No or 
Minimal Burden (score = 0-20), Mild to Moderate Burden (21-40), Moderate 
to Severe Burden (41-60), and Severe Burden (61-88). 

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• Abbreviated cognitive battery (RBANS) 
• Alternative Uses Task 
• Geriatric Depression Scale 
• Geriatric Anxiety Scale 
• Falls Efficacy Scale International 
• Apathy Evaluation Scale 
• Multisensory Reaction Time 
Randomization 
Randomization will occur within a week after completing baseline visits and may 
occur up to 6 weeks before the beginning of intervention. 
6.2.3 Blinding 
Given the interventional nature of the study, it is not possible to blind participants. 
However, the 3 interventional study arms will be described neutrally during consent 
and participants will be assessed in BV1 about their outcome expectations for all 4 
study arms to which they could be randomized. For participants whose study 
intervention was interrupted by the public health restrictions in response to the 
COVID pandemic situation, study expectation questions will include expectations 
about the transition to a virtual environment. Study staff administering baseline visits 
will be blinded to randomization. Two study team members will be unblinded after 
randomization for the purpose of assisting with scheduling interventions and making 
periodic follow-up phone calls. The remaining study staff will be blinded to perform 
follow-up testing visits. The intervention team will not perform any study 
assessments. The study PI and biostatistician will remain blinded until the database is 
locked.  
6.2.4 Follow-up Visits 
Participants will have 13 weeks in which to complete 24 intervention visits. Follow-
up assessments will occur after either 24 intervention visits or 13 weeks. The first 
follow-up assessment will occur between days 0-7 after the completion of the 
intervention, and the second follow-up visit will occur between days 1-21.  The exact 
ordering of tasks may vary to accommodate scheduling needs. For instance, the MRI 
scan may take place on a third visit if that is preferred by the participant. 
The following assessments of the PWD will occur during Follow-up Visit 1 (FV1): 
• QOL-AD 
• Fasting blood draw 
• Geriatric Depression Scale 
• Geriatric Anxiety Scale 
• Apathy Evaluation Scale 

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• Fullerton Advanced Balance Scale 
• Falls Efficacy Scale 
• MRI scan of brain 
The following assessments completed by the CG will occur during Follow-up Visit 1 
(FV1): 
• SF-36 
• Geriatric Depression Scale 
• Geriatric Anxiety Scale 
• Apathy Evaluation Scale 
• Falls Efficacy Scale 
• Fullerton Advanced Balance Scale 
• Expanded Short Physical Performance Battery 
• Zarit Caregiver Burden Scale 
• Neuropsychiatric Inventory Questionnaire 
• Alternative Uses Task 
• Postural Sway 
• Gait Speed and Variability 
The following assessments of the PWD will occur during Follow-up Visit 2 (FV2): 
• Expanded Short Physical Performance Battery 
• Postural Sway 
• Gait Speed and Variability 
• Timed Up and Go 
• Alternative Uses Task 
• Philadelphia Mindfulness Scale 
• Abbreviated Cognitive Battery 
• Multisensory Reaction Time 
The following assessments of the CG will occur during Follow-up Visit 2 (FV2): 
• Abbreviated Cognitive Battery 
• Timed Up and Go 
• Philadelphia Mindfuless Scale 
• Multisensory Reaction Time 
Laboratory Procedures 

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After collection, blood samples will be sent to LabCorb and reports will be returned within 48 
business hours. Each week, the study physician or a proxy physician will review the lab report to 
evaluate for any out of range laboratory values for clinical significance (see Table 4 on page 38). 
Labs that are out of range will be reported to the participant via a letter within 2 weeks of the 
clinician’s review unless the study physician deems it necessary for participant safety to notify 
them sooner, which may be done by telephone and/or letter. All participant lab reports will be 
filed in their study chart. If in-person study visits are prohibited in response to a public health 
emergency, blood collection may not occur. If it is possible to make arrangements for a safely 
and professionally conducted in-home blood draw, an in-home blood draw may occur. Lab 
variables are not a primary outcome. Any missing values will be treated statistically as described 
in the statistical analyses. 
7. SAFETY ASSESSMENTS 
Alphabetical List of Expected Adverse Events for Study Interventions 
• Falling. There is a risk of falling in the movement interventions. If a participant falls 
during the intervention two or more times during the 12-week period, the option to stand 
or walk will be removed and they will be asked to remain seated for the remainder of the 
sessions. 
• Muscle soreness. As with any movement intervention, there is a risk of muscle soreness 
for the movement intervention arms. Movement intensity can be reduced if needed to 
prevent further muscle soreness.  
• Tripping. As with any movement intervention, there is a risk of tripping. If participants 
trip, the interventionist will modify instructions as necessary to prevent further tripping. 
 
7.1 
Specification of Safety Parameters 
There is a small risk of injury during the movement interventions, such as falling or 
muscle soreness. Risk is minimized in the improvisational dance method by always 
beginning seated, always having a seated movement option, and encouraging 
participants to self-select safe and comfortable movements. If a participant falls 
during the intervention two or more times during the 12-week period, the option to 
stand or walk will be removed and they will be asked to remain seated for the 
remainder of the sessions. 
Other data collected for use as covariates may result in health alerts. Below is a table 
of laboratory values considered out of range that would result in notification of the 
participant. Laboratory values are reviewed by staff using the table below. If a value 
is out of range, the study physician is notified, and the participant will be contacted 
within the time period specified by study staff, the study physician, or the PI. 
 
 
 
 

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Table 4. Alert Criteria for Blood Tests and MRI  
Test 
LapCorp 
Reference Range 
Value out of 
reference range:       
Participant should be 
notified at routine visit 
or within two weeks 
by a qualified staff 
member that the value 
is out of the normal 
range for all adults and 
could be discussed 
with Primary Care 
Provider (PCP) but 
may not be medically 
important. (letter) 
Value may be 
medically 
significant:          
Participant should be 
notified at routine 
visit or within two 
weeks by a qualified 
staff member that the 
value is potentially 
medically significant 
and strongly 
recommend that it be 
discussed with PCP. 
(letter with asterisk) 
Value requires 
immediate 
notification:           
Participant should be 
notified within one 
working day by a 
qualified staff member 
that they should contact 
their PCP. (This will be 
recorded and followed  
as an AE unless the 
value reflects a known 
chronic condition or 
expected value based 
on current health status) 
Blood pressure 
  
SBP > 140mm/Hg or 
DBP > 90mm/HG 
SBP > 170mm/HG or 
DBP > 100 mm/HG, 
without symptoms 
>170/100  HG with 
symptoms 
Geriatric 
Depression 
Scale (GDS) 
  
  
≥ 5 
  
MRI 
abnormality 
noted by board 
certified 
neuroradiologist. 
  
As per notation by 
neuroradiologist 
As per notation by 
neuroradiologist 
As per notation by 
neuroradiologist 
Triglycerides 
Normal: <150 
mg/dL 
Borderline-high: 
150−199 mg/dL 
High: 200−499 
mg/dL 
Very high: >500 
mg/dL 
151-200 
201-500 
>500 
Total 
Cholesterol 
Acceptable: 
100−199 
Borderline: 
200−239 
High: ≥240 
>199 
>240 
  
HDL 
Normal: greater 
than 35 mg/dl 
<35 
  
  
HbA1c 
Normal: 4.8 - 
5.6% Prediabetes: 
5.7-6.4%  
Diabetes: >6.4%   
Glycemic control 
for adults with 
diabetes: <7.0% 
≥ 5.7 
6.5-10 
≥10: report as AE       
≥12: report w/in 24 
hours 

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Albumin 
Normal: 3.5-4.8 
g/dL 
>5 or < 3.5 
< 3.0 
<2 
Fibrinogen 
Normal: 193-507 
mg/dL 
<193 or >507 
<100 or >700 
  
CRP 
Normal < 10 
mg/dL 
>10 
>10 
>100 
CBC 
Normal WBC: 
3.4-10.8 
x10E3/uL 
WBC >10.8 or <3.4 
WBC>12 or <4 
WBC>14 or <3 
Hemoglobin            
females 11.1-15.9    
males 13-17.7 
Hemoglobin           
females < 11 or >16     
males <13 or >18 
Hemoglobin          
females <10          
males <12 
Hemoglobin <8 
Hematocrit              
females 34-46.6       
males 37.5-51      
Hematocrit     females 
<34% or >47%    
males <37% or >51% 
n/a 
n/a 
Normal Platelets: 
150-450 
x10E3/uL 
Platelets <150 or > 
450 
Platelets <100 or 
>450 
Platelets < 80 or > 500 
CMP 
Normal: 0.76 - 
1.27 mg/dL 
Creatinine <0.76 or  
>1.27 
Creatinine >1.5 
Creatinine >2 
Normal: 8-27 
mg/dL 
BUN <8 or >27 
BUN >30 
BUN >40 
Normal: 134-144 
mmol/L 
Na < 134 or >144 
Na < 134 or >146 
Na <130 or >150 
Normal: 3.5 - 5.2 
mmol/L 
K < 3.5 or >5.2 
K < 3.4 or >5.5 
K <3.0 or >6 
Normal: 96 - 106 
mmol/L 
Cl <96 or >106 
Cl <98 or >110 
n/a 
Normal: 20 - 29 
mmol/L 
CO2 < 20 or >29 
CO2 < 20 or >29 
CO2 <18 or >35 
Normal: 65-99 
mg/dL 
Glucose <65 or >99 
Glucose <70 or > 125 
Glucose <60 or>500 
Normal: 8.6 - 10.2 
mg/dL 
Calcium  <8.6 or > 
10.2 
<7 or > 12 
> 14 
Normal: 0.0 - 1.2 
mg/dL 
Bilirubin  0-1.2 
>1.5 
>3 
Normal: 0 - 40 
IU/L 
AST        0-40 
> 45 
>70 
Normal: 0 - 44 
IU/L 
ALT       0-44 
> 50 
>70 
OTHER 
Normal: 20.8 - 
226.4 ug/dL 
DHEA-Sulfate <20 or 
>230 
n/a 
n/a 
Normal: 2.6 - 24.9 
uIU/dL 
Insulin <2.6 and >24.9 
n/a 
n/a 
Normal: 6.2 - 19.4 
ug/dL 
Cortisol (AM) <6.2 or 
>19.4 
<3 or >20 
n/a 
  
  
  
  
  

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*If the participant has normal vital signs and feels well, there is no need to invoke emergency medical 
systems* 
 
 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Participants will be asked at least monthly whether there have been any changes in 
their health status, medications, or lifestyle. They will be specifically asked about 
falls. Interventionists will be instructed to report to study staff if a participant 
mentioned a fall or other health event during class. Participants may also report a fall 
or other health event to study staff who are checking them into an intervention, during 
a study visit, or during a reminder call. Unsolicited reports of events will be recorded 
in the study record.  
Any major AE, i.e., any serious injury including all SAEs that are unanticipated, 
serious, and possibly related to the study intervention will be recorded and reported to 
the co-PIs immediately after completing any and all actions that are necessary to 
protect the subject’s health and safety. A description of the event and the date and 
location of the event will be recorded on the AE Reporting Form. The PIs will meet 
quarterly, or as needed, to review all reported events and these will be compiled and 
reported in aggregate to the DSMB at each biannual DSMB meeting. 
 
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is any untoward medical occurrence in a subject during 
participation in the clinical study or with use of the experimental agent being studied. 
An adverse finding can include a sign, symptom, abnormal assessment (laboratory 
test value, vital signs, electrocardiogram finding, etc.), or any combination of these 
regardless of relationship to participation in the study. 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the 
event as it occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect   
An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 

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• Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the NCCIH Program Officer, and Independent Safety Monitor(s) 
within 3 days of the investigator becoming aware of the event.  Other serious and 
unexpected AEs related to the intervention will be reported within 7 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the Independent Safety Monitor(s), IRB, and other oversight 
organizations in accordance with their requirements and will be reported to 
NCCIH on an annual basis.    
• All other AEs documented during the course of the trial will be reported to 
NCCIH on an annual basis by way of inclusion in the annual report and in the 
annual AE summary which will be provided to NCCIH and to the DSMB.  The 
DSMB Report will state that all AEs have been reviewed. 
 
7.4 
Reporting Procedures 
Study progress and safety will be reviewed monthly and more frequently if needed.  
Progress reports, including subject recruitment, retention/attrition, and AEs will be 
provided to the DSMB biannually.  An Annual Report will be compiled and will 
include a list and summary of AEs.  In addition, the Annual Report will address (1) 
whether AE rates are consistent with pre-study assumptions; (2) reason for dropouts 
from the study; (3) whether all participants met entry criteria; (4) whether 
continuation of the study is justified on the basis that additional data are needed to 
accomplish the stated aims of the study; and (5) conditions whereby the study might 
be terminated prematurely.  The Annual Report will be sent to the DSMB and will be 
forwarded to the IRB and NCCIH.  The IRB and other applicable recipients will 
review progress of this study on an annual basis. The PIs will send copies of signed 
recommendations from the DSMB to the NCCIH program officer and IRB within 1 
month of each monitoring review.  
The IRB, DSMB, and NCCIH Program Officials will receive copies of all study 
monitoring/audit or inspection reports within 14 day of PI receipt.  For example, the 
NCCIH (Westat) monitoring report will be submitted to the IRB and DSMB.   
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Daily, Weekly, Monthly 
Study Staff (D, W, M); PI (W, 
M) Study statistician (M) 
Semi-annually 
DSMB 
Status of all enrolled subjects, as 
of date of reporting  
Weekly 
PI, Study Staff 
Semi-annually 
DSMB 
Data entry quality control checks 
on 30% of charts 
Monthly 
Study Staff 
Adherence data regarding study 
visits and intervention 
Weekly 
PI, Study Staff 
Semi-annually 
DSMB 

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7.5 
Follow-up for Adverse Events 
The PI will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after 
the last day of study participation.  At each study visit, study staff will inquire about 
the occurrence of AE/SAEs since the last visit.  Events will be followed for outcome 
information until resolution or stabilization. 
7.6 
Safety Monitoring  
Independent monitoring of this study will be performed by the WFSM Institutional 
Data Safety and Monitoring Board (DSMB). The DSMB includes a panel of monitors 
who are independent of the PI and have previous experience on a monitoring 
committee. The members of this committee are not associated with this research 
project, work independently of the PIs, and have not collaborated or co-published 
with the PIs within the past three years. They are qualified to review the patient safety 
data generated by this study because of their unique expertise, which includes 
research ethics and statistics. It is planned that the DSMB will meet biannually to 
review study progress, data quality, and participant safety, unless at the discretion of 
the DSMB it is felt that more frequent formal contacts are needed.  In addition, an 
emergency meeting of the DSMB may be called at any time by the Chair or the 
NCCIH, should participant safety questions or other unanticipated problems arise. 
8. INTERVENTION DISCONTINUATION  
Participants are free to withdraw from the study at any time and may therefore 
voluntarily discontinue the study. Anticipated reasons for voluntary withdrawal 
include dissatisfaction with randomly assigned study group, dissatisfaction with study 
burden, and change in health status. If a participant does not show up for 3 scheduled 
and confirmed study visits, or stops answering or returning phone calls from study 
AEs and rates (including out-of-
range lab values) 
Monthly 
PI, Study Staff 
Semi-annually 
 
DSMB 
Annually 
NCCIH, IRB 
SAEs (unexpected and related) 
Per occurrence 
PI, DSMB 
NIH/NCCIH 
SAEs (expected or unrelated) 
Per Occurrence 
PI, Study Staff 
Annually 
DSMB, NIH/NCCIH 
Unanticipated Problems 
Monthly 
PI, Study Staff 
Per Policy 
IRB 

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staff for 4 weeks, they will be sent a certified letter to sign. If they do not respond to 
that within a month, they are considered to have dropped out.  
Participants may be asked to discontinue the intervention by study staff if they have 
any change in health status that meets exclusion criteria or is judged by staff, the 
participant, study physician or personal physician to put the participant at risk during 
the intervention or testing. An example of this is beginning a new medication that 
affects alertness or balance during study intervention times. Participants will be 
screened over the phone monthly by staff with a checklist to assess for any major 
changes in health status for all 4 arms of the study. Participants in interventions may 
also mention changes in health status during routine reminder phone calls or to 
intervention instructors. Although poor behavior is not anticipated, participants may 
be asked to discontinue the intervention by study staff if they demonstrate any 
behavior toward study staff, interventionists, or other participants in groups that is 
inappropriate, threatening, or harmful. Participants may also be discontinued from the 
study if the study is closed for any reason.  
Participants may need to temporarily discontinue the study intervention, for example, 
due to short-term changes in health or a family emergency. If this temporary 
discontinuation needs to occur after 10 weeks or more of intervention have been 
collected, study staff will attempt to collect follow-up measures before study 
discontinuation. Otherwise, participants will resume the intervention when possible 
and the gap in treatment will be addressed statistically. If temporary discontinuation 
lasts longer than a month, participants will be asked to complete follow-up visits as 
close as possible to the appropriate time points relative to study enrollment and 
intervention initiation. When participants are ready to resume the study, they will be 
briefly re-screened to ensure that all inclusion and exclusion criteria are still met. 
As this study is a randomized trial, we will attempt to collect data adequate to 
complete intention to treat analyses. Participants who drop out after randomization 
will be mailed a letter inviting them to complete any study visits they are willing to 
complete. Participants who have discontinued the study for any reason (voluntarily or 
by study staff) will be asked if they are willing to complete follow-up visits 1 and 2 at 
appropriate time points relative to study enrollment and intervention initiation and 
will be reimbursed for these visits. If study visits need to be modified for length due 
to constraints on participants’ health or willingness to comply, a reduced battery of 
follow-up measures may be given that focuses on primary endpoints, such as QoL, 
balance, and checklists of mood and behavioral symptoms. If participants are only 
willing to complete one follow-up visit, the visit will be reorganized to include as 
many primary endpoints as possible.  
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
The study uses a full-factorial design to test the main effects of movement and social 
engagement and their possible synergistic effect. Suppose Y  represents the primary 
outcome of interest post-intervention, and 
(
)
BL
Y
the outcome at baseline.  The 

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following ANOVA model forms the basis of the power calculations and subsequent 
analyses: 
 
 
 
 
 
 
 
 
 
(Equation 1) 
where y represents the outcome, X represents the movement component, Z represents 
the social component, and (XZ) represents the interaction between X and Z, and  
represents random error, with, i, j=1,2, and k=1,.,120. Equation (1) decomposes the 
response (QoL measure) into the sum of effect of the variables and controls for value 
pre-intervention. Unlike a classical multi-arm randomized clinical trial, the full-
factorial experiment preserves power, which is driven by the total sample size, not 
cell size. The study design was chosen to maximize power in the short time (3 years) 
provided by the granting mechanism. 
Aim 1: Determine the independent effects of social engagement and dance 
movement on QoL in people with dementia by assessing the main effects of social 
engagement and movement. We will use analysis of variance (Equation 1) to assess 
the main effects of social engagement and movement on QoL. Effect coding for the 
X,Y variables will be used so that the coefficients β1 and β2  in Equation (1) can be 
directly tested and interpreted respectively as main effects of the movement and the 
social components. The null hypotheses are that there is no main effect. Statistically, 
we will test the following two hypotheses: H0: β1 = 0; β2 = 0 at the level of α = 0.05.  
Following common practice, we will not adjust for covariates in testing main effects 
unless severe imbalances occur in cell distributions of demographic variables 
including gender and age. The synergistic effects of the movement and social 
engagement can be evaluated by testing the hypothesis: H0: β3 = 0. 
Aim 2. Assess potential mechanistic links between functional neuroimaging 
metrics, behavioral outcomes, and overall QoL scores using structural equation 
modeling in all groups combined. Aim 2 will be tested using structural equation 
modeling using the path diagram in Figure 2. Movement is hypothesized to exert 
effects on QoL through changes in somatomotor brain networks, a latent variable 
comprised of multiple graph theory-derived measures of connectivity in the 
somatomotor ROI defined in section 3.6.5, including EGlob, ELoc, path length, and 
degree. Changes in somatomotor network structure are hypothesized to result in 
improved gait (a latent variable comprised of gait speed, gait variability, and stride 
length derived from the instrumented mat) and balance (a latent variable including 
balance measured with the FAB, balance confidence measured with the FES, and 
postural sway measured with the force plate). Social engagement is hypothesized to 
alter connectivity in the default mode network, modeled using multiple graph theory-
derived measures of connectivity in the DMN ROI, including EGlob, ELoc, path length, 
and degree. Altered DMN connectivity is hypothesized to result in decreased 
neuropsychiatric symptoms and increased QoL. Structural equation model (SEM) 
analysis[99] will proceed in several stages. First, confirmatory factor analytic models 
will be fitted to the stated indicators for individual latent variables. We will examine 
goodness-of-fit indexes to determine the appropriate measurement models and refine 
the measures if necessary. Second, we will assess the consistency between the 
structural model and the data. Connections that turn out to be not significant will be 
deleted and reported, and alternative hypotheses will be tested. We expect the 
(
)
1
2
3
4
(
)
,
BL
ijk
i
j
ij
ijk
ijk
Y
X
Z
XZ
Y






=
+
+
+
+
+

IMOVE Protocol, Version 6.0 
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iterative model building effort will result in a final structural model that will offer 
insight into the mechanism through which improvisational dancing affects overall 
well-being in the population of people with dementia. We plan to conduct the SEM 
analysis using Mplus v7.4. 
 
Incorporating Virtual Intervention 
For Aim 1, our plan for data analysis would include an adjustment for the possible 
impact of a different mode of delivery of intervention (virtual as opposed to face-to-
face). We will integrate data collected from the virtual intervention into previously 
collected data to preserve power. A variable indicating the mode of intervention 
delivery would be included into the regression model described in section 9.1. The 
revised analysis plan thus might deviate from the original plan that was a priori 
specified in ClinicalTrials.gov.  However, elaboration of our analysis plan at this 
juncture will prevent data mining activities that could be seen as “data fishing”.  
Specifically, we would first test whether or not the virtual indicator variable is 
significant. If both the intervention variable and the virtual indicator are both 
significant, we would further include an interaction between the variables to the 
model. The process follows the hierarchical principle for introducing interaction 
terms. If the interaction term is not significant, then we will not include the 
interaction term into the final model (but keep the indicator of virtual intervention in 
the combined analysis). Similarly, we would consider the possible interaction 
between mode of delivery and baseline outcome QoL measure (section 9.1).  
Besides the primary analysis described above, we would further examine the 
possibility of interaction between mode of delivery and other factors such as age and 
sex in an exploratory analysis.  
For Aim 2, we would first include the indicator variable of mode of delivery into the 
preliminary SEM model for each individual outcome. The variable would only be 
retained in the final model for if its effect is statistically significant from the 
preliminary analysis.   
 
 
9.2 
Sample Size and Randomization 
Our pilot data showed a difference of 1.4 on the QOL-AD between the no-contact 
control and dance group in an 8-week intervention. The pilot did not test separate 
effects of social engagement and dance movement and was an 8-week rather than 12-
week intervention, but the pilot data suggest the amount of change we can expect. For 
power calculations, we used a conservative estimate of effect size of 0.55 per main 
effect. The power of the study using a sample size of 30 per cell in the 2x2 factorial 
design (total N=120) is approximately 85%. A sample size of N=106 is needed to 
achieve 80% power. The power analysis assumed a 2-sided test at α = 0.05, and the 
calculation was conducted using the SAS macro FactorialPowerPlan.[100]  We will 
collect follow-up data on all participants, even those who do not complete the study, 

IMOVE Protocol, Version 6.0 
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to the best of our ability for the purpose of completing an intent-to-treat analysis. If 
sample size is unavoidably reduced as a result of interruptions due to public health 
concerns, power may be reduced. For example, if N=92, then power is approximately 
74%.  
Treatment Assignment Procedures 
Participants will be randomized to one of the 4 study arms: Movement Group (MG), 
Movement Alone (MA), Social Group (SG), or No Contact Control (NC). 
Recruitment will occur in waves. Randomization will be blocked in blocks of 16 that 
each correspond with a wave of data collection; each block will randomize 4 
participants to each of the 4 study groups. Two intervention arms in the study are 
group interventions. Group interventions pose a unique challenge for study 
recruitment, because a minimum number of participants is needed at the same time to 
begin the group. Choosing to randomize over smaller blocks will allow more 
flexibility with study sites and allow waves to begin more quickly after participants 
are enrolled in the study. Also, the study proposes that people with dementia will be 
sex-balanced. It is reasonable that sex-balance will be achieved, as it was in the pilot, 
because while women are more likely to be diagnosed with dementia, they are also 
more likely to be caregivers. However, if gender balance is not met in any wave, 
gender blocking can be employed in the next wave.   
Randomization codes will be generated and maintained by the study statistician. The 
randomization code will be shared with the PI for the purposes of communication 
with the intervention team about timing of group classes and reserving class spaces. 
The PI will not be administering baseline or follow-up testing or performing any 
interventions. If recruitment targets are not being met, planned breaking of the 
randomization code may occur where an intervention group will be started with a 
smaller number of participants than intended. In this event, randomization to other 
study arms will be adjusted to match the intervention group and maintain balance 
across the arms. Also, later groups may be larger in order to compensate or an 
additional wave may be added. Randomization will be approximately balanced by 
sex. Women are more commonly diagnosed with dementia than men, but women are 
also more commonly caregivers than men. The pilot study was approximately 
balanced by sex. Therefore, we anticipate that overall, sex will be approximately 
balanced in PWD in this study and will randomize accordingly. 
Given the nature of the intervention, it is not possible for participants to be blinded. 
Interventionists will also not be blinded. Study staff performing baseline visits will be 
blinded to the randomization code to eliminate the potential for bias in assignment to 
treatment arm. Two study staff will be unblinded to the randomization code after 
baseline testing for the purpose of scheduling interventions and making reminder 
calls.  
Participants will be instructed not to mention their study group to staff prior to 
beginning follow-up testing. However, unintentional breaking of randomization codes 
may occur if a participant mentions their study group to the study staff performing 
their follow-up visit. Also, while most interventions will take place away from the 
hospital, there is a small chance that study staff blinded to randomization code might 

IMOVE Protocol, Version 6.0 
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see a participant going to or coming from an intervention session. The influence of 
potential breaking of randomization code on follow-up data should be minimal 
because 1) participants will have been fairly randomized at the beginning of the 
study, which is the primary purpose of randomization, 2) study staff will be trained to 
administer testing according to protocol and will follow the protocol, and 3) an 
occasional instance of unintentional breaking of randomization code will not 
introduce systematic bias into the data. If randomization is unintentionally broken, 
this will be recorded on a notes page in the participant’s study binder. 
9.3  
Definition of Populations 
Intention to treat analysis will include all participants randomized to each arm who 
have follow-up data. Appropriate efforts will be made to get follow-up measures of at 
least the primary outcome on all participants. If a participant is lost to follow up after 
baseline data collection, the participant will not be included in data analysis. See the 
section on missing value for description for treating missing values due to dropping 
out after FV1 or partially missing values (Section 9.6). Per protocol analysis will 
include all participants who completed the trial without major protocol deviations.  
9.4 
Interim Analyses and Stopping Rules 
There are no planned interim analyses or stopping rules due to the brief duration of 
the intervention and small number of participants in each arm (n=30). 
9.5 
Outcomes  
9.5.1 Primary Outcome   
Quality of life (QoL). We will measure QoL in PWD using the QOL-AD, a measure 
of QoL validated in people with dementia who had Mini-Mental State Exam (MMSE) 
scores as low as 10.[65-67] This study targets early-stage dementia and MCI, 
meaning MMSE scores will be 15 or above for all participants, putting them well 
within the range for the QOL-AD to be a valid measure. We will measure QoL in CG 
using the Short Form-36 (SF-36).[93, 94] QoL will be measured in BV1 and FV1. 
The primary outcome will be QoL in the PWD measured with the QOL-AD at FV1. 
9.5.2 Secondary Outcomes   
Secondary Outcomes of Interest. 
Measurements of Gait and Balance. We have proposed improved gait and balance 
as potential mechanisms through which dance can improve QoL for people with 
dementia. These measures have been defined above in section 6.2.2. 
• Fullerton Advanced Balance Scale (FAB)  
• Postural sway  
• Gait speed and variability  
• Expanded Short Physical Performance Battery (eSPPB).   

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Measurement of Neuropsychiatric Symptoms. We have proposed improvement of 
neuropsychiatric symptoms, particularly apathy and depression, as a potential 
mechanism through which dance may improve QoL in PWD. 
• Neuropsychiatric Inventory Questionnaire (NPI-Q).  
• Geriatric Depression Scale (GDS) and Geriatric Anxiety Scale.  
• Apathy Evaluation Scale (AES).  
MRI Neuroimaging.  We have hypothesized that behavioral improvements due to 
dance (gait/balance and neuropsychiatric symptoms) are accompanied by changes in 
brain function that can be measured noninvasively using magnetic resonance imaging 
(MRI). The primary neuroimaging outcome of interest is graph theory-derived 
measures of network structure calculated on resting state fMRI images. The primary 
imaging metrics of interest are: 1) community structure, 2) global efficiency (EGlob), 
3) local efficiency (ELoc), and 4) path length (described below). 
• Acquisition. A high resolution T1-weighted image will be collected using a 
3D volumetric MPRAGE sequence. Images will be immediately re-acquired if 
artifacts due to motion or other sources are detected. Whole-brain network 
connectivity will be assessed using blood oxygenation level-dependent 
(BOLD) imaging during resting state, where participants are asked to view a 
cross in the middle of a screen with eyes open.[101]   
• Preprocessing.T1 MRI images will be warped into template space and 
segmented into grey matter, white matter, and cerebrospinal fluid using 
publically available software. fMRI data will be aligned to the T1 data, then 
warped to template space by applying the transforms computed on the T1 
data. Distortion correction will be performed using EPIREG in FMRIB’s 
Software Library (FSL).[102, 103] To control for physiological noise,[104] all 
data will be preprocessed to remove head motion, global, white matter, and 
cerebrospinal fluid signal.[105, 106]  
• Generation of Whole Brain Network.  Graph theory analysis will be performed 
in collaboration with the WFSM Laboratory for Complex Brain Networks 
(LCBN) (PI: Laurienti) using their established methodology.[107-126] Each 
brain network will be generated from preprocessed, spatially normalized images. 
The first step in performing the network analysis is to generate a whole brain 
connectivity matrix, or adjacency matrix. This is a binary n X n matrix, where n = 
the number of voxels in the fMRI data (~20,000). The matrix notes the presence 
or absence of a connection between any two nodes (i and j) determined by the 
correlation coefficient between each node and every other node. These values 
will be used to produce a correlation coefficient matrix. A threshold is applied to 
the correlation matrix to dichotomize the data such that values above the 
threshold indicate that a connection is present.  This threshold will be set based on 
the LCBN’s recent work showing a universal relationship between node number 
and connection density.[112]  This process yields the binary adjacency matrix.  
The binary adjacency matrix defines the graph (the nodes and the edges that 
connect them) for each individual. The diagram in Figure 1 illustrates a graph; 
circles represent nodes (voxels) and lines represent edges (superthreshold 

IMOVE Protocol, Version 6.0 
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correlations). Neuroimaging data typically follow the organization of a small-
world network.[127, 128] Small-world networks are characterized by having 
high clustering of nodes within the network, allowing for local specialization, 
at the same time as short path lengths, which allow for rapid spread of 
information. Path length refers to the number of edges that must be crossed to 
get from one node to another. For example, the minimum path length between 
A and B in Fig. 1 is 2, and the maximum (without crossing an 
edge more than once) is 7. Clustering refers to how tightly 
connected the neighbors of a node are. In Fig. 1, the grey 
nodes, black nodes, and white nodes form tightly clustered 
communities within the graph.  
• 
Graph theory-derived outcomes of interest.  Path length is 
the number of edges that must be crossed to get from one node 
to another. Longer path length in people with AD has been 
associated with slower cognitive performance, beta amyloid 
deposition, and depression.[129-131]  
• 
Global Efficiency (EGlob)  reflects the efficiency with which 
information from one node can move through the network.[132] EGlob is 
scaled from 0 (no long-range information processing) to 1 (maximal 
distributed processing). Decreased Eglob has been associated with aging, 
cognitive impairment, and depression.[131, 133] 
• Local Efficiency(ELoc) is related to clustering, and reflects the efficiency with 
which information from one node is propagated to its neighbors.[132] It is 
also scaled from 0 (no local connectivity) to 1 (maximal local connectivity – 
all connections are local) and has been observed to change with cognitive 
impairment and depression.[131]  
• Community Structure/Modularity. Community structure analyses will be 
performed to assign each voxel to a network community or module. A 
community or module is defined as a collection of network nodes that are more 
interconnected with each other than with the rest of the network. In Fig. 1, the 
light grey, black, and white nodes form 3 distinct communities more connected 
within themselves than with the rest of the network. We will compute modularity, 
or Q,[134, 135] to assess community structure strength in the brain networks 
using the “Louvain” algorithm.[136] Modularity (Q) ranges from 0 (no 
community structure) to 1 (perfectly modular network). We will repeat the 
analysis 10 times on each network and choose the partition with the highest Q 
value. The consistency of community structure and the strength (Q-value) for 
each network node will then be assessed across all individuals.  Our work shows 
decreased modularity associated with decreased physical function,[109] and 
others have shown that cognitive impairment and AD are associated with altered 
modularity.[130, 137] 
• Regions of interest. Average values of graph-theory derived outcomes will be 
extracted from regions of interest (ROIs) using WFU Pickatlas software.[138] 
The somatomotor region will be defined as the bilateral precentral (primary 
motor), postcentral (primary somatosensory), and paracentral gyri defined in 
the automated anatomical labeling (AAL) atlas.[139] The default mode 
Figure 1. Diagram of a graph 

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network (DMN) is a group of brain regions that reliably decrease activation on 
PET and fMRI scans during a task. These regions of multimodal cortex do not 
follow clear anatomical boundaries as primary somatomotor cortex does. 
DMN regions will be defined by a mask of regions deactivated during a 
sensory attention task[92] that is incorporated into WFU Pickatlas as an ROI.  
Tertiary Outcomes 
Tertiary outcomes include outcomes measured for the purposes of statistical 
adjustment, anticipated reviewer concerns/questions, or addressing alternate 
hypotheses.  
• Demographic characteristics including age, gender, race, years of education, 
and employment history will be recorded as covariates.  
• Self-reported medical history will be used to determine the presence of 
major medical conditions for inclusion/exclusion. Participants will be asked to 
bring in all medications and dietary supplements for a "brown bag" review. 
• Height and weight will be measured to calculate body mass index.  
• Blood pressure 
• NEO Five Factor Inventory (NEO-FFI).  
• White matter lesion burden. Changes in gait and balance are common in AD 
and are correlated with neurodegenerative processes in the brain such as 
accumulation of beta amyloid. However, changes in gait and balance are also 
linked to burden of white matter hyperintensities.[140] Thus, burden of white 
matter lesions will be assessed by acquiring T2-FLAIR images. The volume 
of white matter lesions will be calculated using the Lesion Segmentation 
Toolbox implemented in SPM[141] for use as a covariate. 
• Allostatic load. Social engagement may change biomarkers of stress, 
including cortisol and allostatic load,[142-144] a composite measure of blood-
based biomarkers associated with chronically elevated stress. Cortisol may be 
elevated in PWD[145] and is often elevated in CGs.[145, 146] Lifestyle 
modifications like participating in support groups can reduce stress 
biomarkers in CGs,[147, 148] and we have pilot data showing that cortisol 
levels may decline in PWD in response to an engagement group that includes 
dance movement. Therefore, we will measure and test the effects of stress 
biomarkers in our model. 
• Effect of the intervention on CGs, and indirect effects on PWD through 
effects on CGs. We chose to focus this proposal on the effects of dance on 
PWD because effect sizes on CGs for QoL, balance, mood, and neural 
networks were small or absent in the 8-week pilot. Nevertheless, the effect of 
the 12-week intervention or testing in a larger population might yield benefit 
for CGs that could influence outcomes. Outcomes of the intervention on CGs 
will be available to use as covariates to test whether effects on CGs modify 
effects on PWD. 
o Short Form-36 (SF-36). QoL will be measured in CGs using the SF-
36. CGs may also benefit from the intervention.  
o Zarit Caregiver Burden Scale. CG burden will be assessed using the 
Zarit 22-item CG Burden Scale.[98]  

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o Mood will be assessed using the Geriatric Depression Scale and 
Geriatric Anxiety scales as listed above. 
o CGs will also be asked to complete assessments of balance, gait, and 
physical function listed above.  
 
9.6 
Data Analyses  
Analysis of Aim 1: Determine the independent effects of social engagement and 
dance movement on QoL in people with dementia by assessing the main effects 
of social engagement and movement. We will use analysis of variance (Equation 1) 
to assess the main effects of social engagement and movement on QoL. Effect coding 
for the X,Y variables will be used so that the coefficients β1 and β2  in Equation (1) 
can be directly tested and interpreted respectively as main effects of the movement 
and the social components. The null hypotheses are that there is no main effect. 
Statistically, we will test the following two hypotheses: H0: β1 = 0; β2 = 0 at the level 
of α = 0.05.  Following common practice, we will not adjust for covariates in testing 
main effects unless severe imbalances occur in cell distributions of demographic 
variables including gender and age. The synergistic effects of the movement and 
social engagement can be evaluated by testing the hypothesis: H0: β3 = 0. 
 
Analysis of Aim 2. Assess potential mechanistic links between functional 
neuroimaging metrics, behavioral outcomes, and overall QoL scores using 
structural equation modeling in all groups combined. Aim 2 will be tested using 
structural equation modeling using the path diagram in Figure 2. Note that Figure 2 
represents a cross-sectional “slice” of the overall longitudinal model of 3 time points. 
QOL will be modeled longitudinally using longitudinal SEM. With the Markov 
assumption, we will analyze the data in which QOL is the outcome variable and 
covariates include both time-varying and non-time-varying measures. Movement is 
hypothesized to exert effects on QoL through changes in somatomotor brain 
networks, a latent variable comprised of multiple graph theory-derived measures of 
connectivity in the somatomotor ROI defined in section 3.6.5, including EGlob, ELoc, 
path length, and degree. Changes in somatomotor network structure are hypothesized 
to result in improved gait (a latent variable comprised of gait speed, gait variability, 
and stride length derived from the instrumented mat) and balance (a latent variable 
including balance measured with the FAB, balance confidence measured with the 
FES, and postural sway measured with the force plate). Social engagement is 
hypothesized to alter connectivity in the default mode network, modeled using 
multiple graph theory-derived measures of connectivity in the DMN ROI, including 
EGlob, ELoc, path length, and degree. Altered DMN connectivity is hypothesized to 
result in decreased neuropsychiatric symptoms and increased QoL. Structural 
equation model (SEM) analysis[99] will proceed in several stages. First, confirmatory 
factor analytic models will be fitted to the stated indicators for individual latent 
variables. We will examine goodness-of-fit indexes to determine the appropriate 
measurement models and refine the measures if necessary. Second, we will assess the 
consistency between the structural model and the data. Connections that turn out to be 
not significant will be deleted and reported, and alternative hypotheses will be tested. 

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We expect the iterative model building effort will result in a final structural model 
that will offer insight into the mechanism through which improvisational dancing 
affects overall well-being in the population of people with dementia. We plan to 
conduct the SEM analysis using Mplus v7.4. The SEM model in Fig. 2 will be 
modified if the final sample size is deemed not sufficient to support the original 
proposed complex model.  
 
 

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Missing Data. Several analytic strategies will be used to treat missing values. The 
primary analysis will analyze the QoL-AD score at FV1. If a participant does not 
have FV1 data at all, we will not include the participant. If there is partially missing 
data (e.g., missing response to a question in a survey), we will use multiple 
imputation (MI) to handle the missing value. The missing-at-random principle (but 
not the completely-missing-at-random MCAR, a more restrictive assumption) will be 
followed, and MI will account for uncertainty associated with the missing values. 
For secondary analyses that involve both FV1 and FV2, first we will exclude 
participants that drop out after baseline measurement. For missing at random (MAR) 
Figure 2. Path diagram for proposed SEM analysis. Grey shaded squares represent components of the intervention 
hypothesized to be generating an effect. Circles represent latent variables in the model. Boxes connected to circles with an 
arrow to represent observed variables used to create latent variables. Solid lines represent hypothesized effects. Dashed 
lines represent alternative hypotheses. AES=Apathy Evaulation Scale, DMN=default mode network, FAB=Fullerton 
Advanced Balance Scale, FES=Falls Efficacy International Scale, GDS=Geriatric Depression Scale, SM=Somatomotor. 

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and not missing at random (NMAR), generally speaking there is no true test unless 
additional data are available from those that have missing values. One can use 
experience and judgment to determine if MAR is a reasonable assumption. It needs 
to be pointed out that there are tests for checking MCAR vs MAR, the most 
commonly used one being Little’s test [149]. Because we do not assume MCAR, 
which is a stricter assumption than MAR, we do not plan to conduct this test.  
 
 
It is not possible to tell directly from examining the data whether or not 
missingness is missing at random or not. If from clinical observations we suspect 
that data are not missing at random (e.g., sicker patients with lower cognitive 
measures are more likely to miss the cognitive measures), we will use statistical 
models such as pattern-mixture model[150] to assess the impact of missingness of 
data on the results.  Pattern-mixture models do not assume missing at random and 
allow different distributions of missing values for different patterns of missing data. 
For example, if we are willing to assume that missing values follow some given 
patterns, then we will be able to evaluate the effect of intervention on different 
groups of patients with different missing patterns. Because of the relatively small 
sample size, the investigation of pattern-mixture is likely to be limited to a small 
number of patterns of missingness.  
The current situation of a public health emergency may result in additional missing 
data, for example if in-person data collection visits are prohibited. If missing values 
occur for a dependent variable (e.g., neuroimaging, blood draw) then observations 
that contain valid values will be used and those with missing values will not be used. 
In this study, the variables most affected would be secondary and tertiary variables. If 
the measured variable is an independent variable, the procedures for missing values 
outlined above will be used. 
 
Exploratory Analyses 
The unavoidable changes in study design and sample size resulting from the COVID-
19 public health emergency have the potential to impact the interpretation of 
outcomes. The planned analyses above are the primary analyses for the study and will 
be conducted as described. Additional exploratory analyses may be conducted to 
maximize information gained from the grant. These exploratory analyses could 
provide hypothesis-generating information to help guide future work and identify 
potential new biological mechanisms through which movement and social 
engagement affect PWD and their CG. Potential exploratory include 1) voxel-wise 
analyses of brain network data to assess whether movement or social engagement 
altered connectivity metrics; 2) effects of movement and social engagement on white 
matter integrity using NODDI data, 3) whether biomarkers of stress are affected by 
social engagement and movement intervention in PWD and CG, 4) whether 
movement and social engagement using an improvisational method can enhance 
divergent thinking (a measure of creativity) in PWD and CG, and 5) whether 
divergent thinking is associated with CG burden or neuropsychiatric symptoms in 
PWD. The exploratory analyses will closely follow the analytic plan for the primary 
outcome. The dependent variable would be the potential variables described above, 
and the primary predictor would be intervention condition.  

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Types of data collected include 1) paper forms, 2) electronic data, and 3) 
neuroimaging data. All data collection will be performed by trained study staff who 
are blinded to the participant’s study arm. Every effort is made by the investigators, 
study staff, sponsor(s) and their agents to maintain confidentiality of protected health 
information collected in the study. All of the materials collected are for research 
purposes only and will be held in strictest confidence. All WFSM faculty and staff 
receive annual trainings in privacy, protection of personally identifiable information, 
and HIPAA regulations. 
Confidentiality of data is maintained by using research identification numbers that 
uniquely identify each individual.  Data other than demographic information will not 
use names as an identifier; research ID numbers will be used.  Data will be used only 
in aggregate and no identifying characteristics of individuals will be published or 
presented.  
Written records will be kept in locked cabinets in the Sticht Center on Aging. Files 
matching participants' names and demographic information with the research ID 
numbers are kept in a separate room and locked file with a different key from for all 
other files. Files may be obtained from the research unit only by authorized study 
personnel. After the study is completed, local data will be stored with other 
completed research studies in a secured storage area. 
Digital records, including brain imaging data, will be stored on password protected, 
network drives behind the WFSM firewall. These drives are routinely backed up and 
access to the drives is limited to necessary personnel. Brain imaging data are stored 
using subject number and date of acquisition as identifiers. The study PI regulates 
access to the drives used for brain imaging data.  
No information concerning the study or the data will be released to any unauthorized 
third party without prior written approval of the sponsor. The study monitor or other 
authorized representatives of the sponsor may inspect all study documents and 
records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) for the study subjects.  The clinical study 
site will permit access to such records. 
 
10.2 Data Management  
As this is a single-site study, all data will be collected by study staff at this site. The 
header of all data collection forms includes a unique numerical study identifier (study 
ID number), a unique alphabetical identifier (“acrostic”), the date the form was 
collected, the initials of the study staff who completed the form, the study name, and 
the study visit (e.g., baseline visit 1). The footer for all data collection forms includes 
version number and page. Paper data collection forms will be kept locked and secured 
at the study site. After data collection on paper forms, data will be entered into a 
REDCap database that is password protected and accessible only by study staff in 0-7 

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days after data are collected. Only the PI will have permission to download 
identifying information from the REDCap database and the PI will assign data access 
for all study staff. After data is entered by one study staff member, data entry will be 
checked for at least 30% of participants by a separate person. 
10.3 Quality Assurance  
10.3.1 Training 
Training on the cognitive testing battery will be conducted using materials provided 
by the ADCC by a study coordinator trained through the ADCC. First, the complete 
cognitive battery will be reviewed verbally while showing the study staff member 
data collection and administration forms. The study staff member will be taught how 
to administer each test individually, including instruction on common mistakes and 
variations in response and how to code them. The study staff member will take the 
cognitive tests administered by a trained staff member. The study staff member will 
have opportunities to practice administration until they feel confident administering 
the testing. They will then be observed by the lead study coordinator and will be 
audiotaped to document appropriate testing technique. During their first study visit, 
they will be accompanied by a lead study coordinator. If there are any concerns about 
the performance of the testing, any necessary training will be repeated.  
Training on administration of non-cognitive tests will occur similarly. Lead study 
staff have been trained in proper administration of tests by Pepper Center and 
Alzheimer’s center staff. When a new study staff member joins the team, they will be 
familiarized with the CRF and the battery of tests that will be administered. They will 
be instructed how to administer each test individually and will be allowed to ask 
questions. Instruction will include common mistakes and variations in response and 
how to code them. The study staff will practice administration until they report being 
confident administering the testing. At this point, study staff will be observed 
administering the test to another staff member. If a lead study coordinator judges that 
testing technique is appropriate, the study staff will complete a study visit 
accompanied by a lead study coordinator. If there are any concerns about the 
performance of the testing, any necessary training will be repeated. 
A training refresher will be conducted for all study staff on all measures annually to 
ensure consistency in administration. During this training, correct administration of 
tests will be reviewed, and all study staff will demonstrate testing. In addition, weekly 
laboratory meetings will include discussion of any questions study staff may have 
about administration, scoring, or interpretation of testing. 
10.3.2 Quality Control Committee  
Quality control will be completed by the study team.  
10.3.3 Metrics 
Quality control metrics for non-imaging data will be generated from computerized 
reports generated from the database after data entry. Monthly reports will identify 
missing data, values that are out of range, and track attendance, as well as show plots 

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of primary outcome measures to identify outliers that may signify data entry errors. 
These metrics can be generated by REDCap. A study staff member will be identified 
who will routinely generate these measures in REDCap approximately 24 hours prior 
to the monthly study meeting. The study staff member will present the data to the 
study team and data errors will be agreed upon by the team. During the meeting, a 
study staff member will be assigned an action to correct the data entry error. This will 
be documented in the meeting minutes as an action item and follow-up will be added 
to the next month’s agenda. When data are corrected in REDCap, REDCap software 
automatically tracks the date, time, and user who modified the database.  
At the end of the study, histograms of the data distribution for each variable will be 
generated to identify outliers that may signify errors in acquisition or data entry. 
Many variables in the study will be acquired at 2 or 3 time points. For these variables, 
histograms of differences will be generated. This additional step can identify data 
acquisition or entry errors through unusual amounts of change.    
Quality assessment will performed on MRI data at 3 time points on all data sets and 
results will be recorded in a REDCap form accessible by all study team members. 
First, raw data will be viewed after being transferred from the scanner and converted 
into nifti format to ensure completeness and assess for imaging ghosting and 
reconstruction errors. After preprocessing, data will be viewed again to assess for 
errors and residual motion. Finally, data will be viewed to assess any errors during 
processing. All image processing steps will be verified before summary metrics are 
extracted for the final statistical analyses. All data quality questions will be referred to 
co-PI (Hugenschmidt). 
10.3.4 Protocol Deviations 
A computerized tracking system will be used to document participant attendance, 
generate quality control reports for identifying protocol deviations and to assess 
protocol adherence. Any unanticipated problems, serious and unexpected adverse 
events, deviations or protocol changes will be promptly reported by the principal 
investigator or designated member of the research team to the IRB and sponsor or 
appropriate government agency if appropriate. The study team will generate Study 
Reports for the DSMB and will provide information on the overall status and timeline 
of the study including enrollment status, recruitment, subject status (i.e., number 
completed), safety events, and protocol deviations. Study Report tables will be 
generated only from aggregate (not by group assignment) baseline and safety data for 
the study population. Study team meetings will occur at least twice a month, and 
quality control metrics will be reviewed once a month.  
10.3.5 Monitoring 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator.  The scientific PI (Hugenschmidt) will be 
primarily responsible for data quality and management. A computerized tracking 
system will be used to document participant attendance, generate quality control 
reports for identifying protocol deviations and to assess protocol adherence. 
Telephone screening and in-person assessment interviews are conducted by trained 

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study staff who enter data directly into desktop or laptop computers. 
Questionnaire data are stored on paper forms and in electronic databases. Staff will be 
instructed to review all forms for completeness after each study visit.  Data from hard 
copy forms will be entered into a web-based system with range and other cross-form 
validation checks to exclude erroneous values.  A randomly selected subset of subject 
data will be double data entered to check data entry accuracy. Careful development of 
data collection forms is crucial (a) to ensure systematic and uniform recording of 
participants’ data (b) to facilitate complete data collection, and (c) to minimize the 
possibilities for data entry error.  Data entry screens are created to mimic the forms.  
Forms are easy to read and interpret, and designed for ease of data entry.  
Video data will be stored on networked, password protected hard drives and backed 
up to separate password protected hard drives and/or HIPAA-compliant cloud 
storage. Videos of individuals will be identified using subject number. Group videos 
will be identified using the group name and date. 
Brain imaging data are stored on dedicated drives on Wake Forest School of 
Medicine’s secure network and are identified using subject number. Quality 
assessment will performed upon data acquisition and after processing. All image 
processing steps will be verified before summary metrics are extracted for the final 
statistical analyses. All data quality questions will be referred to the neuroscience PI 
(Hugenschmidt). 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol, the informed consent document, data collection forms, and advertising 
will be reviewed and approved by the WFSM IRB. Any modifications to these forms 
that affect participant safety or burden will also be reviewed and approved by the IRB 
prior to implementation.  
11.2 Informed Consent Forms 
Signed informed consent will be obtained from each subject. The primary outcomes 
for this study are QoL and biomarkers collected from the PWD. However, the CG 
will be an active participant. Important data will be collected through the CG about 
the PWD, and other important data will be collected about the CG for the purpose of 
testing for alternate hypotheses and controlling for factors such as caregiver 
personality and mood that might influence the CG’s reports about the PWD. 
Therefore, written informed consent will be obtained from each PWD and caregiver.  
If public health safety concerns limit in-person study activities, consent will be 
administered virtually following current IRB-approved guidelines. In all cases, IRB-
approved administration of consent will be obtained prior to any data collection. 
The informed consent process will follow the procedures of the WFU Institutional 
Review Board.  The study interviewers will explain the purpose, methods and extent 

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of the study to prospective participants.  The potential participant is asked to read the 
informed consent form and ask questions.  The form is written in simple easy to 
understand language.  We require study staff to review all of the key aspects of the 
study verbally with the potential participants. Staff then question potential 
participants to ascertain whether they have understood the information.  Potential 
participants who are illiterate or have impaired vision must have the consent read to 
them, followed by review of the checklist, opportunity for questions, and discussion. 
A copy of the signed and dated consent form will be given to participants, and the 
original document will be placed in subjects’ individual study files, which will be 
stored in a secure location. In compliance with the Health Insurance Portability and 
Accountability Act (HIPAA) and the Standards for Privacy of Individually 
Identifiable Health Information of the Department of Health and Human Services, we 
will access personal health information only after obtaining informed consent. 
 
11.3 Participant Confidentiality  
Confidentiality will be protected by collecting only information needed to assess 
study outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study 
information in a secure manner. To help ensure subject privacy and confidentiality, 
only a unique study identifier will appear on the data collection form. Any collected 
patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file, store separately from the data. The linkage file will be 
kept secure, with access limited to designated study personnel. Following data 
collection subject identifying information will be destroyed at the earliest 
opportunity, consistent with data validation and study design, producing an 
anonymous analytical data set. Data access will be limited to study staff. Data and 
records will be kept locked and secured, with any computer data password protected. 
No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 
 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the 
FDA, or other government agencies as part of their duties to ensure that research 
participants are protected.  
12. COMMITTEES 
Adjudication of cognitive status will occur through the ADCC adjudication 
committee, a multidisciplinary panel of experts in determining cognitive status. If for 
any reason adjudication cannot be performed through the ADCC adjudication 
committee, an adjudication committee may be formed with the guidance of the 
ADCC that will include a comparable panel of experts. 

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13. PUBLICATION OF RESEARCH FINDINGS  
This study will comply with the NIH Public Access Policy, which ensures that the 
public has access to the published results of NIH funded research. 
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