Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Sponsor: Indiana University

 
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Lifestyle Interventions for the Treatment of EOAD Study (LITES) 
 
Dustin B. Hammers, PhD, Associate Professor 
Indiana University School of Medicine 
355 West 16th Street 
Indianapolis, IN 46202 
 
 
 
 
Co-Investigators/Mentors: 
 
Frederick Unverzagt, PhD, Professor 
Indiana University School of Medicine 
355 West 16th Street 
Indianapolis, IN 46202 
 
Liana G. Apostolova, MD, Professor 
Indiana University School of Medicine 
355 West 16th Street 
Indianapolis, IN 46202 
 
 
Support Provided by: 
Alzheimer’s Association 
National Institute of Aging 
 
 
 

 
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Table of Contents: 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
2.3 
Tertiary/Exploratory/Correlative Objectives 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
3.3 
Tertiary/ Exploratory/ Correlative Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 
Data Safety Monitoring 
11.0 
Study Withdrawal/Discontinuation 
12.0 
Statistical Considerations 
13.0 
Data Management 
14.0 
Privacy/Confidentiality Issues 
15.0 
Follow-up and Record Retention 
16.0 
References 
17.0 
Appendix

 
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Abbreviations 
 
AA 
Alzheimer’s Association 
ACTIVE 
Advanced Cognitive Training for Independent and Vital Elderly 
AD 
Alzheimer’s Disease 
ADCS-
ADL 
Alzheimer’s Disease Cooperative Study – Activities of Daily Living 
ANCOVA 
Analysis of Covariance 
ATRI 
Alzheimer’s Therapeutic Research Institute 
BDI-2 
Beck Depression Inventory - 2 
CANTAB 
Cambridge Neuropsychological Test Automated Battery  
CSRQ 
Cognitive Self-Report Questionnaire 
DSMC 
Data Safety Monitoring Committee 
EOAD 
Early-Onset Alzheimer’s Disease 
GUID 
Global Unique Identifier 
IU 
Indiana University 
LAR 
Legally Authorized Representative 
LEADS 
Longitudinal Early-Onset AD Study 
MCI 
Mild Cognitive Impairment 
MOCA 
Montreal Cognitive Assessment 
MSPSS-6 
Multidimensional Scale of Perceived Social Support 6 
PCQ 
Perception of Change Questionnaire  
PSS-4 
Perceived Stress Scale 4 
QOL-AD 
Quality of Life in Alzheimer’s Disease 
RCT 
Randomized Clinical Trial 
SAE 
Significant Adverse Event 
 
1.0 
Background & Rationale 
 
EOAD is an Overlooked Condition 
Despite the rapid expansion of research on interventions for Alzheimer’s disease (AD), 
treatment for patients diagnosed at a younger stage of life (aged 40 to 64 years old) has been 
overlooked. This is likely due to the rareness of the condition – less than 5% of patients with AD 
have onset before 65 years old 1 – and also to challenges identifying disease modifying 
treatments in traditional-onset AD. These “early onset-AD” (EOAD) patients experience a 
unique set of complications related to their functioning, including cognitive declines while raising 
families and performing at the height of their careers. As a result of relatively preserved insight 
and this early decline, elevated rates of depression are common in EOAD 2. Identification of 
successful treatments for this condition would lead to significant improvements for patients and 
families across multiple aspects of life. 
 
EOAD and Traditional-Onset AD Present Differently 
EOAD does not appear to be traditional-onset AD at an earlier age. EOAD tends to possess a 
more aggressive disease course 3 and greater cognitive severity 4 than traditional AD. 
Additionally, EOAD is proposed to manifest with greater relative involvement of non-memory 
cognitive domains, 5 and phenotypes associated with logopenic progressive aphasia, posterior 
cortical atrophy, progressive ideomotor apraxia, frontal variant AD, and corticobasilar syndrome 
are common 4. Subgroups of EOAD tend to have higher rates of neurological symptoms than 
traditional AD and decreased comorbidities such as diabetes, obesity, and circulatory disorders 
6. On magnetic resonance imaging, greater parietal and overall cortical atrophy is seen in 

 
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EOAD, with less atrophy in the medial temporal lobe and hippocampus 7. Relatedly, 
fluorodeoxyglucose positron emission tomography studies show greater parietal lobe 
hypometabolism in EOAD, 8 and diffuse tensor imaging studies indicate that white-matter 
degradation in EOAD patients is greater posteriorly (posterior cingulate and parietal), with less 
medial temporal involvement 9. While recent studies have suggested some promise of 
monoclonal antibodies (i.e., Lecanemab) for the treatment of traditional AD, at present no 
attempts at pharmacological interventions in EOAD have been undertaken.  
 
Lifestyle Interventions Offer Promising Results 
Extensive research on the benefit of lifestyle interventions for older adults’ functioning exists 
across a variety of cognitively intact and impaired samples. Computerized cognitive training, for 
example, has repeatedly shown benefit in a host of conditions impacting cognition, including 
brain injury 10 and healthy aging 11. The largest study of its kind – a randomized controlled trial 
(RCT) of 2800 older adults in the Advanced Cognitive Training for Independent and Vital Elderly 
(ACTIVE) study 12, 13 – showed that cognitive training improved cognitive performance in non-
demented older adults upon completion of training, 12 and at 2-years, 12 5-years, 14 and 10-years 
post-training 15. BrainHQ (Posit Science) is a brain plasticity-based adaptive cognitive training 
program involving a suite of 29 online exercises that target several cognitive domains. Since 
2019, >50 studies have been published on the use of BrainHQ, including those showing 
treatment benefits in cognitively intact participants, 16, 17 and those with schizophrenia, 18 Mild 
Cognitive Impairment (MCI), 19, 20 and mood disorders 21. Training dosage effects have been 
observed in older adults with or without a cognitive disorder, with higher rates of training 
suggesting greater benefit from treatment 22. Additionally, stronger cognitive training 
improvements have been suggested in participants with stronger baseline cognition, 22 and 
preliminary evidence in MCI suggests that women show greater treatment effects compared to 
men 23. 
 
 
Physical exercise paradigms have additionally been shown to benefit cognition 24, 25. A recent 
meta-analysis of 13 RCTs (n = 673) showed that physical exercise interventions improved 
performance in patients with AD on the Mini-Mental State Exam (SMD=1.12, CI: 0.66-1.59) 
compared to control groups 26. A separate meta-analysis of 20 studies (n=2,553) of Tai Chi 
intervention in adults aged 60 and over found support for cognitive enhancement 27. Specifically, 
effect sizes were large (Hedge’s g =0.51; p=0.003) for executive functioning outcomes in 
cognitively healthy adults relative to controls, and moderate (Hedge’s g =0.35; p=0.004) for 
global cognition outcomes in cognitively impaired adults 27. A more recent systematic review (9 
studies, n=456) suggested Tai Chi improved short-term cognitive function in the elderly, 
including for global cognitive functioning, visuospatial skills, semantic memory, verbal 
learning/memory, and self-perception of memory 28. 
 
The unique benefits of cognitive training and physical exercise have led some researchers to 
combine these treatments into a single intervention. Meta-analytic findings of 10 RCTs (n=742) 
involving combined cognitive training and physical exercise suggest a small-to-medium positive 
effect of interventions on global cognitive function (SMD=0.32, CI: 0.17-0.47) in older adults with 
MCI and dementia, and a moderate-to-large positive effect for activities of daily living (SMD = 
0.65, CI: 0.09-1.21) 29. Additional research is underway to examine the efficacy of a cognitively-
enhanced Tai Chi intervention on cognitive health delivered remotely to older adults with MCI 
(“Tai Ji Quan: Moving to Maintain Brain Health”; NIH 5R01AG059546), with preliminary data 
(n=69) suggesting feasibility, acceptability, and safety of the intervention 30. The synergistic 
effects of using both interventions have been associated with “guided plasticity facilitation” 31-33. 
Specifically, it is proposed that physical exercise facilitates synaptic plasticity and neurogenesis 
due to the release of neurotrophic factors like brain-derived neurotrophic factor (BDNF) and 

 
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cytokine/hormonal factors, 34 and stimulation of synapses and neurons during cognitive training 
guides synapse formation and integration of new neuronal structures in brain circuitry, resulting 
in enhanced gray matter/dorsolateral prefrontal lobe density 35, 36 and cognitive processing 32.  
 
An Opportunity Exists for Lifestyle Interventions in EOAD 
As a result of this support for lifestyle 
interventions, we offer a conceptual model 
(Figure 1) of cognitive and Tai Chi exercise 
training for improved cognition in EOAD 
individuals, moderated by individual 
differences in training and participant 
variables. To date, these interventions have 
had limited consideration in EOAD 
populations, due to its rareness and the 
severity/aggressive course commonly 
observed in EOAD 4. Given the increased 
focus on EOAD by the Alzheimer’s 
Association and leading AD scientists, this 
reflects a gap in knowledge in AD literature. This also overlooks a potential treatment option for 
patients with EOAD and their families. Consequently, we are undertaking an NIH-defined Stage 
IB (NIH Stage Model) study to collect preliminary data to investigate the feasibility and pilot 
testing of this combined lifestyle intervention on short-term and long-term cognition, functioning, 
and mood in participants with EOAD from the Longitudinal Early-Onset Alzheimer’s Disease 
Study (LEADS), relative to an Active Control group. Because LEADS is a multi-site study across 
the U.S., all aspects of this proposed study will be conducted remotely. Current LEADS 
participants classified as amyloid-positive EOAD (n = 60) will be recruited for our study. Our 
research team is uniquely positioned to examine this model, given our extensive experience 
with lifestyle interventions, access to the most well-characterized cohort of EOAD participants in 
the U.S., and the inclusion of several pre-eminent scholars in neurodegeneration, AD clinical 
trials, and EOAD. We are currently unaware of any other research attempting to identify the 
efficacy of lifestyle interventions in this population. 
 
Preliminary Data: As the goal of this application is to generate preliminary data on the benefit 
of cognitive and Tai Chi training in participants with EOAD – which has previously been 
unexamined in the literature – little to no previous findings exist to directly support our proposal. 
As such, a brief review of related literature will be provided to support our Aims.  
 
Aim 1. Evaluate feasibility of a lifestyle intervention and outcomes in participants with 
EOAD 
In a recent pilot study applying BrainHQ cognitive training to patients with mild to moderate 
traditional-onset dementia, 8 of 10 participants studied were able to complete the 36 hours of 
cognitive training, with participant eagerness, rate of non-refusal, and attentiveness being strong 
(refusal rate for the 384 training sessions was only 3%) 37. Cognitive screening scores on the 
Montreal Cognitive Assessment (MOCA) were notably low (M = 13.1 ± 1.6), suggesting that 
BrainHQ can be tolerated by severely-cognitively impaired populations. These results are 
relevant to our proposal as the mean MOCA score for our current EOAD cohort is 16.9 (± 5.6). 
Relatedly, both BrainHQ and Tai Chi have been found to be efficacious when administered 
remotely-to-home, 16, 38 consistent with the procedure planned for the current study. Together, 
these findings suggest that use of this lifestyle intervention remotely in our cognitively 
compromised EOAD cohort is feasible.  
 
Figure 1. Proposed Conceptual Model of Intervention Effects in EOAD 

 
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Aims 2 & 3. Efficacy and Moderation of a lifestyle intervention 
in EOAD 
Dr. Unverzagt (Co-Mentor) has been centrally involved with 
lifestyle interventions – and cognitive training in particular – over 
the past 20 years. He has shown that memory impaired 
participants failed to benefit from memory training in the ACTIVE 
program, but did show expected training gains on domains of 
reasoning and processing speed 13 (Figure 2). Additionally, his 
work helped show the aforementioned benefit of cognitive training 
in ACTIVE immediately and after a delay 12, 14, 15. Overall, his 
research into cognitive training established empirical support 
for the paradigm – paving the way for its application in EOAD – 
and suggests that severity of memory impairment may play a 
moderating role in treatment outcomes in our sample. 
 
 
 
 
2.0 
Objective(s) 
 
2.1 
Primary Objective 
 
The Primary Objective is to evaluate the feasibility of the combined lifestyle intervention 
and outcome assessments for use in future trials in participants with EOAD. Hypothesis 
1.a: We will monitor adherence to interventions and outcome assessments. Adherence to 
treatments and completion of outcome assessments will be ≥75% and ≥90%, respectively. 
Hypothesis 1.b: We will monitor acceptability and attrition of the lifestyle intervention. At least 
70% of participants will rate each aspect of the intervention as enjoyable, and attrition will be 
<15%.   
 
2.2 
Secondary Objective 
 
The Secondary Objective is to investigate if the lifestyle intervention combining cognitive 
training and Tai Chi improves (2a) short-and long-term cognition and (2b) functioning 
and mood in participants with EOAD compared to an active control condition. Hypotheses 
2.a and 2.b: The EOAD participants in the experimental training condition will perform better on 
outcomes related to (2.a) cognition and (2.b) functioning and mood at Week 15 and Week 40 
follow-up compared to the EOAD participants assigned to the active control condition. 
 
2.3 
Tertiary/Exploratory/Correlative Objectives 
 
The Tertiary Objective is to explore potential moderators on the degree of benefit from a 
combined cognitive training and Tai Chi lifestyle intervention in EOAD. Because of sample 
size limitations in this preliminary study, focus will be on determining effect sizes and sample-
size magnitude needed for future work. Exploratory hypotheses include: Hypothesis 3.a: A 
Figure 2. Improvements in 
cognition on reasoning/speeded 
training post-treatment (PT) and at 
follow-up years 1 (A1) and 2 (A2) 

 
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greater treatment response will be seen in women with EOAD relative to men. Hypothesis 3.b: 
Better response will be related to increased hours of training and decreased disease severity.  
 
3.0 
Outcome Measures/Endpoints 
 
3.1 
Primary Outcome Measures 
 
To not interfere with the NACC-UDS 3.0 battery being administered at annual LEADS visits, the 
current study will administer a novel and streamlined battery at Baseline, immediately after 
completion of treatment (at Week 15 Post-Intervention Follow-Up), and approximately 6-months 
after treatment (at Week 40 Post-Intervention Follow-Up).  
 
Primary outcome measures will be Week 15 and Week 40 Post-Intervention Follow-Up 
performance on CANTAB Connect computerized Cognitive Composites of Memory and 
Executive skills, after controlling for the respective baseline Composite performance. The 
Memory Composite will be calculated from CANTAB Connect measures of Paired Associates 
Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher 
scores reflected better performance. The Executive Composite will be calculated from CANTAB 
Connect measures of Stockings of Cambridge, Spatial Working Memory, Rapid Visual 
Processing, and Match To Sample subtests, with higher scores reflected better performance. 
 
CANTAB measures were selected for their assessment of memory, executive functioning, and 
visuospatial working memory, with validation in AD samples 39. Based on meta-analytic findings 
40, cognitive domains of episodic memory and executive/working memory were expected to 
result in the highest benefit from behavioral interventions, which provides rationale for our 
selection of Memory and Executive Cognitive Composites. CANTAB Connect research has 
suggested that at-home testing is feasible 41 and practice effects are generally low with repeat 
testing,42 making it appropriate for use in this remote repeated assessment protocol. 
 
3.2 
Secondary Outcome Measures 
 
Secondary outcomes include performance on the following measures at Week 15 Post-
Intervention Follow-Up and Week 40 Post-Intervention Follow-Up, after controlling for baseline 
performance: 
a. Cognitive Self-Report Questionnaire (CSRQ), which is a 25-item self-report questionnaire 
of subjective cognitive difficulties 43. Scores range from 0-125, with higher scores denoting 
greater symptoms of cognitive impairment. This measure has been used in a variety of 
studies examining benefit from cognitive training 44, 45. 
b. Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory 46 (ADCS-
ADL) scale. This informant-based rating scale assesses the participant’s ability to perform 
a variety of activities of daily living over the past four weeks, and has been shown to 
discriminate between healthy elderly controls and those with mild AD 46. Scores range 
from 0-78, with higher scores denoting better functional ability. 
c. 21-item Beck Depression Inventory-2 (BDI-2) 47 was used as a measure of self-reported 
depression. Scores range from 0-63, with higher scores denoting greater self-reported 
depression symptoms.  
d. Perceived Stress Scale 4 (PSS-4)53 was used as an index of self-reported psychological 
stress. Scores range from 0-16, with higher scores denoting greater self-reported stress54. 
e. Quality of Life in Alzheimer’s Disease (QOL-AD)55 is a 13-item self-report and informant-
report questionnaire rating various aspects of physical health, energy, family, money, etc., 
using a scale of poor (1 point), fair (2 points), good (3 points), and excellent (4 points). 

 
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f. 6-Item Multidimensional Scale of Perceived Social Support (MSPSS-6) 56 was used as a 
measure of self-reported support from family, friends, and a significant other. Scores range 
from 1-7, with higher scores denoting greater perceived social support 57.  
 
3.3 
Tertiary/Exploratory/Correlative Outcome Measures 
 
A brief self-reported Perception of Change Questionnaire (PCQ) will also be administered to 
gauge blinding procedures. Further, exploration of participant satisfaction will be undertaken 
with the use of two separate satisfaction surveys (Cognitive Training Satisfaction Survey and 
Exercise Satisfaction Survey) for each aspect of the combined intervention. Each survey will 
assess safety/ability to navigate, challenge and enjoyment, appropriateness of intensity, 
helpfulness in improving brain health, and overall intervention satisfaction. Each survey has 
been modified from a previously documented Tai Chi satisfaction survey 30.  
 
 
4.0 
Eligibility Criteria 
 
4.1 
Inclusion Criteria 
 
• 
Enrolled in the Longitudinal Early-Onset AD Study (LEADS), 48 and being classified via 
LEADS consensus criteria as having amyloid-positive EOAD 
• 
Aged 40-64 years at the time of enrollment into LEADS 
• 
Fluent in English 
• 
In good general health and absent another neurological disorder 
• 
Have a knowledgeable informant.  
• 
Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into 
LEADS. 
• 
Have sufficient vision, hearing, comprehension, and manual dexterity to participate in the 
testing and training program 
 
 
4.2 
Exclusion Criteria 
 
• 
Have access to the internet (e.g., home, family, , etc.) for less than 4 hours per week.  
 
 
5.0 
Study Design 
 
This research study aims to generate preliminary data regarding the efficacy of a combined 
cognitive-training and Tai Chi exercise lifestyle intervention in participants diagnosed with 
EOAD. Participants will complete a series of cognitive, functional, and mood assessments at a 
remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) 
Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome 
measures will be repeated immediately after treatment (15 Week Post-Intervention Follow-up 
visit) and at the 40 Week Post-Intervention Follow-Up visit . Specific Aim 1 will examine the 
feasibility of this lifestyle intervention and outcome assessments when applied to participants 
with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-
term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether 
individual differences in training or clinical/demographic characteristics moderate the degree of 
benefit from this intervention; owing to sample size limitations in this feasibility study, focus of 

 
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this latter aim will be on determining effect sizes and sample-size magnitude needed for future 
work.  
 
The following schematic provides an overview of the study procedures: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total N: Recruit from current LEADS EOAD participants. Review inclusion 
and exclusion criteria. Obtain informed consent.  
Randomize (1:1) 
Experimental Arm 
(N = 30) 
Control Arm 
(N = 30) 
Experimental Training (~ 14 Weeks) 
•
Computerized Cognitive Training  
•
Tai Chi-Qi Gong Exercises 
Active Control (~ 14 Weeks) 
•
Computerized Games  
•
Stretching Exercises 
Baseline (Visit 1) 
Assessment of cognition, functioning, and mood using: 
CANTAB computerized assessment, CSRQ, QOL-AD, ADCS-ADL, BDI-2, PSS-4, MSPSS-6, 
Off-Line Training Form, Demographics Questionnaire, Contact Information Sheet, Anti-Amyloid 
Treatment Information Form 
Week 15 Post-Intervention Follow-Up (Visit 2) 
Assessment of cognition, functioning, and mood using: 
CANTAB computerized assessment, CSRQ, QOL-AD, ADCS-ADL, BDI-2, PSS-4, MSPSS-6, 
PCQ, Exercise and Cognitive Training Satisfaction Surveys, Off-Line Training Form, Anti-
Amyloid Treatment Information Form 
Week 40 Post-Intervention Follow-Up (Visit 3) 
Assessment of cognition, functioning, and mood using: 
CANTAB computerized assessment, CSRQ, QOL-AD, ADCS-ADL, BDI-2, PSS-4, MSPSS-6, 
Off-Line Training Form, Anti-Amyloid Treatment Information Form 

 
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6.0 
Enrollment/Randomization 
 
Recruitment 
 
The proposed study will recruit 60 participants with amyloid-positive Early Onset Alzheimer’s 
Disease through the ongoing NIH-funded multi-center Longitudinal Early-Onset Alzheimer’s 
Disease Study (LEADS). To date, LEADS has enrolled 370 EOAD participants, along with 115 
early-onset non-AD and 99 control participants. New participants will be added to LEADS on a 
rolling basis until final enrollment numbers reach 400 EOAD participants, 200 early-onset non-
AD participants, and 100 control participants.  
 
The LEADS sites for recruitment include Indiana University (IU) and a subset of other sites 
throughout the multi-site study, potentially including Banner Health Research Institute, Butler 
Hospital/Brown University, Columbia/Presbyterian Medical Center, Georgetown University, 
Houston Methodist Hospital, Massachusetts General Hospital, Mayo Clinic - Jacksonville, Mayo 
Clinic – Rochester, John Hopkins Medicine, Stanford University, University of California – Los 
Angeles, University of California – San Francisco, Emory University, Northwestern University, 
University of Pennsylvania, Washington University in St. Louis, Wien Center – Mount Sinai 
Medical Center.  
 
Individuals will be recruited by LEADS study members during ongoing LEADS appointments. 
When participants arrive to these already-scheduled LEADS appointments, a LEADS research 
member will let them know that they may be eligible for a research study that examines the 
benefit of a combined lifestyle intervention for EOAD. Site researchers will provide potential 
participants with limited study information and Dr. Hammers/Study Coordinators contact 
information. The LITES research team will also obtain diagnosis, demographics, and contact 
information of LEADS participants at a point after their LEADS baseline visit to 1) confirm 
eligibility and 2) additionally identify those who are eligible to enroll in LITES and directly contact 
them. Following the completion of a telephone screen, those interested in participating will be 
scheduled for the informed consent process at a convenient time, and informed consent will be 
obtained through the IU IRB-approved e-consent process (given the remote nature of this 
study). Study procedures may either immediately follow written consent, or be scheduled for 
another visit, depending on interest and availability. Despite the low risk of this study, there is 
the possibility that some participants with EOAD will have limited capacity to provide informed 
consent. In those instances, consent will be obtained from the participant’s legally authorized 
representative (LAR) and assent will be obtained from the participant with EOAD. First name, 
telephone number, and email addresses will be obtained to confirm the scheduled visit,but will 
be destroyed upon completion of the study.  
 
Participants will be able to access study procedures using either their personal computer or 
tablet, or using a tablet provided by the study team. 
 
Randomization and Blinding 
 
Participants will be randomly assigned to the experimental or active control group via a 
computer-generated schedule. Randomization will occur after the Baseline visit in permuted 
blocks of six with random variation of blocking number. Given the increasing likelihood for 
participants to be prescribed an Anti-amyloid medication (e.g., Lecanemab) after the first year of 
enrollment, an adaptive randomization design will be implemented upon the first instance of a 
recruited participant taking such a medication pre-enrollment. Group membership will be coded 
and blinded until analyses are complete. Participants will be informed that the intervention 

 
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involves “cognitive and physical exercises” to enhance face validity of all groups and blind 
participants to group assignment. They will be told that two different types of training programs 
are being studied to see which one works best. The effectiveness of participant blinding will be 
evaluated by administering a questionnaire at post-treatment to compare the groups on self-
reported perception of change in cognitive function (PCQ). We will also compare the proportions 
of voluntarily withdrawals from each group. 
 
7.0 
Study Procedures 
 
The Appendix includes materials that participants will receive regarding BrainHQ, CANTAB, 
Demographics Questionnaire, Anti-Amyloid Treatment Information Form, CSRQ, QOL-AD, 
ADCS-ADL, BDI-2, PSS-4, MSPSS-6, PCQ, Exercise and Cognitive Training Satisfaction 
Surveys, and Self-Reported Off-Line Training Forms. 
 
Procedures:  
 
1. Informed Consent. Informed consent will be sought from all individuals that will 
participate in the proposed projects, including participants (and their informants). When a 
potential participant has been identified s/he will be presented with a brief overview of 
the study, as well as a brochure that further describes the study and its procedures. 
Additional questions will be answered by the LITES principal investigator or research 
assistant(s). If interested, a virtual visit will be scheduled to review the informed consent 
document with the potential participant (and informant), answer additional questions, and 
obtain written consent (through the e-consent process). For participants at Indiana 
University, the study team will additionally offer the participant the opportunity to proceed 
through the consent process in person in conjunction with their in-person LEADS visit. 
Since many of our potential participants will be cognitively impaired, we will also make a 
determination about capacity to provide informed consent. Following presentation of the 
informed consent document, participants will be asked questions about the study (e.g., 
purpose, procedures, risk and benefits). If these questions are adequately answered, 
then the participant will be judged to have capacity to provide informed consent. 
However, if these questions are not adequately answered, the participants will be judged 
to not have this capacity. In these latter cases, assent will be obtained from the 
participant and informed consent will be obtained from the participant’s LAR (e.g., 
spouse, adult child). 
 
At the conclusion of informed consent, participants will receive a participant manual that 
will serve as a step-by-step guide for accessing the lifestyle training program to which 
they have been assigned.  
 
 
2. Baseline (Visit 1). During this visit, participants will complete measures of baseline 
functioning pertaining to cognition (CANTAB and CSRQ), daily functioning (ADCS-ADL), 
and mood (BDI-2, PSS-4, MSPSS-6, QOL-AD). Demographics Questionnaire, Anti-
Amyloid Treatment Information Form, and Off-Line Training Form will additionally be 
administered. This visit should take approximately 13-4 hours. 
 
 
 
 
3. Lifestyle Intervention 

 
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a. Experimental Training Program:  
 
i. Remote Computerized Cognitive Training from Posit Science’s BrainHQ 
Program. 
This web-based application 49 was designed to improve the speed and accuracy 
of memory, executive functioning, and visual processing skills. Exercises will 
continually adjust difficulty levels to maintain an 85% correct rate. A set of 
computerized cognitive training exercises have been selected based on their 
validation in lifestyle intervention programs for older adults. Users will be 
expected to play 18 levels per session, 4 sessions per week for 14 weeks. Below 
is an example of a cognitive exercise that will appear in their schedule: 1) A 
divided attention and visual tracking task that requires the monitoring of a select 
number of moving objects upon a backdrop filled with identical moving objects. 
As the task continues the number of objects the participant must track increases 
(“Target Tracker”).  
 
To use the experimental treatment program, a participant opens an Internet-
browser and navigates to a general log-in screen via the LITES website or clicks 
on the BrainHQ app downloaded onto their laptop or tablet from the App Store or 
Google Play store. The participant then logs into the experimental treatment 
program server using an anonymized email address and password created on 
their behalf by a staff member. This will allow us to track their progress through 
the program and provide personalized reminders for training. A game-like 
experience begins, where the participant is encouraged to earn stars and in-
game rewards to advance. To do so, the participant completes the cognitive 
exercises scheduled for the day, and must achieve at least 6 stars to advance to 
the next exercise in their queue (stars are derived from normalized z-score 
performance). Notification of session completion is achieved when the user 
finishes at least 18 levels. The exercise itself contains the core therapeutic 
exercise task built into a game-like experience. Participants perform numerous 
trials over the course of a session, with auditory and visual feedback and rewards 
to indicate if the trial was performed correctly or incorrectly. Within each session, 
target frequency is titrated according to performance to maintain ~80% target 
accuracy across training session. Also, after each session, the difficulty of the 
next session is updated (e.g., less inter-stimulus-interval jitter) to ensure that 
each participant is appropriately challenged. Summary screens including game 
metrics (stars, scores) and exercise metrics (usage, progress) are shown to the 
participant at the end of each session. All usage and progress data are encrypted 
then transmitted to a central server. In a research study such as this one, no 
personally identifiable information is stored on the server (including internet 
protocol addresses). On the server, the data are available for review by an un-
blinded research coordinator through a secure web portal. The research 
coordinator will use the secure web portal to regularly check on usage and 
progress of each active participant to customize their biweekly telephone calls to 
provide helpful guidance and coaching, if needed, outside of the telephone 
reminders.  
  
The scheduling mechanism ensures that a participant progresses through the 
exercises in an optimally defined order, generally moving from simple (e.g., 
easy to discriminate stimulus types, moderate pacing) exercises to complex (e.g., 

 
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greater self-pacing required, greater rule complexity) exercises over the course 
of the 14-week experience.  
  
Participants will be asked to complete 18 levels per session (approximately 45 
minutes), 4 sessions per week for 14 weeks (corresponding to approximately 40 
hours of training total). 
 
At the start and completion of the 14-week BrainHQ training, participants will 
receive a 5-10-minute Train-to-Task measure through the BrainHQ portal that will 
gauge the amount of learning that occurred over the course of the training 
(independent of the cognitive outcomes). 
  
ii. Tai Chi- Qi Gong Exercises.  
This remote training of Tai Chi exercises will be modeled after the virtually-
administered Tai Ji Quan: Moving for Better Balance program 50. Specifically, it 
will involve practice of a core of 8 therapeutically-modified exercise forms aimed 
at stimulating and integrating musculoskeletal, sensory, and cognitive systems 51. 
These self-initiated Tai Chi exercises will additionally incorporate synchronized 
breathing, center of gravity displacement, and unilateral weight-bearing and 
weight-shifting movements (of the trunk, pelvis, ankle, head, and hands). 
Participants will be asked to complete 14 hours of training total (in 30-minute 
sessions, 2 days per week for 14 weeks). Initial sessions will focus on learning 
and engaging in Tai Chi movements across multiple positions (e.g., seating, 
standing only, stepping) as necessary, with later sessions honing skills. Because 
participants will live in multiple time zones, pre-recorded videos created by the 
Tai Chi Foundation specifically for the current study – using Tai Chi Foundation 
certified instructors  - will be available to watch online individually through an 
online portal. 
 
 
b. Active Control Training Program:  
 
i. 
Computerized Games Through the BrainHQ Web Portal.  
A set of computerized games have been selected that are engaging, but have 
not been empirically validated to improve cognition. In each training session, 
participants will be presented with at least 5 pre-determined exercises, each 
lasting for 9 minutes, for a total of 45 minutes. Participants will be asked to 
complete 40 hours of training total (in 45-minute sessions, 4 days per week for 
14 weeks).  
 
ii. Stretching Exercises. 
Active Control participants will also be provided video-instructional materials 
through a series of stretching routines. The central aspect of the exercise will 
involve stretching of the upper and lower body, and trunk. Participants will be 
asked to engage in these stretching exercises twice per week, for approximately 
10-15 minutes per session. This will total 7 hours over the course of 14 weeks. 
Because participants will live in multiple time zones, pre-recorded videos created 
by a certified physical therapist through Yes2Next.com will be available to watch 
online individually through an online portal.  
 
 

 
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Of note, all participants will receive an anonymized email address and password for Posit 
Science/BrainHQ, which will determine the specific cognitive training content that they can 
access. For example, participants randomized into the Active Control arm will only have access 
to the active control training through the BrainHQ web portal. A separate set of instructions will 
be created for access to the respective online video-instruction for physical exercise. The 
amount of time spent on BrainHQ will be tracked based on the number of levels completed per 
session (which corresponds to a particular amount of time). This will be paired with a paper-and-
pencil “training log” for each participant to record the date and start/stop times of each of their 
cognitive and exercise sessions. These variables may be used in the proposed moderation 
analyses in Specific Aim 3.   
 
 
Remote coaching and technical support. Both computer programs through the BrainHQ 
portal will be accompanied by a coaching and technical support service by IU staff familiar with 
BrainHQ, to provide ongoing participant support and ensure that any technical issues are 
resolved promptly and successfully. This familiarity will be enhanced with coaching documents 
provided by BrainHQ. Staff will conduct remote 15-minute check-ins with participants every two 
weeks to discuss progress and answer questions. This remote support system is consistent with 
existing lifestyle interventional trials, such as EXERT, US POINTER, PACT, among others. 
 
 
4. Week 15 Post-Intervention Follow-Up (Visit 2). Upon completion of the intervention 
schedule (approximately 14 weeks after baseline), the outcome measures (CANTAB, 
CSRQ, QOL-AD, ADCS-ADL, BDI-2, PSS-4, MSPSS-6) will be repeated for all 
participants. The PCQ will also be administered to gauge blinding procedures. Exercise 
and Cognitive Training Satisfaction Surveys and Off-Line Training Form will also be 
administered. This visit should take approximately 3-4 hours.  
 
 
5. Week 40 Post-Intervention Follow-Up (Visit 3). Approximately 6 months after the 
completion of training, outcome measures (CANTAB, CSRQ, QOL-AD, ADCS-ADL, BDI-
2, PSS-4, MSPSS-6, and Off-Line Training Form) will again be repeated for all 
participants. This visit should take approximately 3-4 hours. 
 
 
 
8.0 
Study Calendar 
 
 
 
Baseline 
(Visit 1) 
Lifestyle Training 
Intervention 
Week 15 Post-
Intervention 
Follow-Up (Visit 2) 
Week 40 Post-
Intervention 
Follow-Up (Visit 3) 
Week 1 
Week 1 – Week 14  
Week 15 
Week 40 
STUDY 
PROCEDURES 
 
 
 
 
CANTAB  
X 
 
X 
X 
CSRQ 
X 
 
X 
X 
ADCS-ADL 
X 
 
X 
X 
BDI-2 
X 
 
X 
X 
PSS-4 
X 
 
X 
X 
MSPSS-6 
X 
 
X 
X 
QOL-AD 
X 
 
X 
X 

 
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Baseline 
(Visit 1) 
Lifestyle Training 
Intervention 
Week 15 Post-
Intervention 
Follow-Up (Visit 2) 
Week 40 Post-
Intervention 
Follow-Up (Visit 3) 
Week 1 
Week 1 – Week 14  
Week 15 
Week 40 
Demographics 
Questionnaire  
X 
 
 
 
 
Contact Information 
Sheet  
X 
 
 
 
Anti-Amyloid Treatment 
Information Form 
X 
 
X 
X 
Cognitive Training 
 
X 
 
 
Train-to-Task 
Measurement 
 
X (twice; at start 
and end of training) 
 
 
Exercise Satisfaction 
Survey 
 
 
X 
 
Cognitive Training 
Satisfaction Survey 
 
 
X 
 
Self-Reported Off-Line 
Training Form 
X 
 
X 
X 
Exercise Training 
 
X 
 
 
Perception of Change 
Questionnaire 
 
 
X 
 
 
*Variations of +/- 3 weeks from the scheduled visit are permitted 
 
9.0 
Reportable Events 
 
There are no expected adverse events. As described in the Protection of Humans subjects, it is 
possible that participants will experience distress related to cognitive training, or could lose their 
balance as a result of following along with the Tai Chi or Stretching videos. As such, keeping a 
chair nearby while engaging in exercise is being encouraged. Otherwise, there are no other 
known side effects anticipated. All promptly reportable events will be reported to the IU IRB 
within 5 business days of discovery. All non-promptly reportable events will be reported to the IU 
IRB at the time of the next study renewal or at the time of study closure if no renewal is 
required. Any serious adverse event will be reported within 24 hours of learning of the event, in 
accordance with the standard IU IRB reporting guidelines.  
 
Participants will be informed in the consent document for Specific Aims 1-3 of circumstances 
under which licensed psychologists might be required to break confidentiality due to mandated 
reporting laws. These cases include: concerns for participants’ risk to self (suicidality) or others 
(homicidality), or information that suggests a child, older adult, or dependent adult are being 
abused. If a participant described an intent or inability/unwillingness to develop and follow a 
safety plan, Dr. Hammers will be immediately located for additional assessment and 
intervention, and will work in conjunction with the respective LEADS site-PI given the remote 
nature of the data collection.  
 
10.0 
Data Safety Monitoring 
 
This data safety monitoring plan was developed based on prior studies using similar types of 
cognitive training (including BrainHQ) and Tai Chi exercises, where no adverse events have 

 
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been reported (i.e., relatively low risk to participants). This plan will monitor the collected data 
for accuracy and completeness. The Principal Investigator, Research Assistant, and data 
manager will review the study data and files for accuracy and completeness after the first six 
participants’ data are collected. If procedures are not accurately or completely capturing study 
data, then procedures will be modified to allow for more accurate and complete data capture. If 
any changes in the procedures will be necessary, then the IRB be informed in an amendment. If 
these changes are approved by the IRB, then the Alzheimer’s Association and the National 
Institute of Aging will be informed of these changes in our annual progress report. All research 
data will be stored on encrypted Indiana University (IU) servers as well as encrypted external 
hard drives that will be kept in a locked cabinet in the PI’s office. Additionally, participant 
identifiers will be stored separately from the coded test data.  
 
A Safety Officer/ Medical Monitor has been obtained to review on an ongoing basis the safety of 
all subjects enrolled in this clinical trial. Meetings will be held approximately quarterly – as 
necessary – after the first subject is enrolled and will be held via virtual conference. The 
frequency of meetings may change at the discretion of the Safety Officer. The Safety Officer will 
be regularly informed of the occurrence of any serious adverse event (SAE) and immediately 
notified of any fatal or life-threatening event. After reviewing the safety data, the Safety Officer 
will make recommendations regarding the conduct of the study. These recommendations 
include amending the safety monitoring procedures, modifying the protocol or consent, 
performing additional analyses, terminating the study, or continuing the study as designed. 
Given the co-enrollment of the proposed study’s participants with the LEADS study, the Safety 
Officer is also affiliated with the Data and Safety Monitoring Committee (DSMC) utilized by 
LEADS. Specifically, the Alzheimer’s Therapeutic Research Institute (ATRI) at the Keck School 
of Medicine of the University of Southern California serves as the DSMC for LEADS, and Dr. 
Michael Rafii (ATRI Medical Director) has agreed to serve as Safety Officer for the current 
study. Any subsequent reports will be filed in the regulatory binder at IU, with a copy also being 
sent to the LEADS Executive Committee and the IRBs at all participating sites. 
 
The following will be monitored as part of the Data Safety Monitoring Plan: data quality, subject 
recruitment, accrual, retention, outcome and adverse event data, assessment of scientific 
reports or therapeutic development, results of related studies that may impact subject safety, 
and procedures designed to protect the privacy of subjects. No pre-planned stoppage analyses 
will be conducted given the preliminary nature of the data collection. 
 
11.0 
Study Withdrawal/Discontinuation 
 
Withdrawal from the study will occur by the participant (or study partner) contacting the PI or 
study team to report a desire for study discontinuation. Withdrawal prior to the completion of the 
lifestyle interventions will result in a discontinuation of access to BrainHQ and the Tai 
Chi/Stretching exercise programs. 
 
12.0 
Statistical Considerations 
 
All statistical hypothesis tests will be performed on a comparison-wise basis, using a 2-sided 
α=0.05 without adjustment for multiple comparisons. The risk of inflated Type 1 error due to 
multiple comparisons will be limited in the current aims by designating a small number of 
primary analyses for each Specific Aim. A total sample size of n = 60 (n = 30 per arm) is being 
used in this study.  
 
 

 
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Analysis: Hypothesis 1.a: “Adherence to treatments and completion of outcome assessments 
will be ≥75% and ≥90%, respectively.” Successful adherence will be defined as participants 
completing 75% of training sessions/visits across the 14-week intervention. Successful 
completion of 15-Week and 40-Week Post-Intervention Follow-Up outcome assessments will be 
defined as obtaining valid outcome data in 90% of assessments. One-sample proportion tests 
will be used to determine differences from expectation (e.g., difference between observed 
adherence and 75%). 
Hypothesis 1.b: “At least 70% of participants will rate each aspect of the intervention as 
enjoyable, and attrition will be <15%.” An intervention attrition rate of <15% for both cognitive 
and Tai Chi exercises will define successful study retention. Dropping out of the intervention will 
mean notifying project staff of discontinuation, or not responding to participation reminders after 
falling behind training goals. Exploration of participant satisfaction will additionally be 
undertaken with the use of two modified five-item surveys, with “satisfaction” defined as 
endorsing “Extremely Satisfied” or “Somewhat Satisfied”; we specified an a priori overall 
satisfaction level of ≥70% for both cognitive training and Tai Chi. One-sample proportion tests 
will be used in this hypothesis as well to determine differences from expectation. 
 
Power: Our hypothesized adherence rate of 75% was based on similar studies in the literature. 
Previous research observed 79% adherence with a virtual Tai Chi- Qi Gong intervention, and 
77% adherence to BrainHQ in MCI participants.52 Our sample size of 60 would permit an 
estimated power of 0.80 to detect a proportion difference of 10% at a significance level of 0.05.  
 
     
 
Analysis: Primary outcome measures will be 15-Week and 40-Week Post-Intervention Follow-
Up performances on Memory and Executive Composites from CANTAB Connect. Secondary 
outcomes include CSRQ, QOL-AD, ADCS-ADL, PSS-4, MSPSS-6, and BDI-2 scores. 
Hypothesis 2.a: Treatment effect will be analyzed using Analysis of Covariance (ANCOVA) 
comparing CANTAB Connect Composites at both 15-Week and 40-Week Post-Intervention 
Follow-Up visits for the experimental treatment arm versus active controls, while controlling for 
the baseline performance. Hypothesis 2.b: ANCOVA analyses will be used to compare 
treatment effects at 15-Week and 40-Week Post-Intervention Follow-Up for functioning and 
mood-related outcomes.  
  
 
Power: We expect to complete the 15-Week and 40-Week Post-Intervention Follow-Up visits for 
92.5% and 85% of the 60 randomized subjects, respectively (which accounts for attrition).  
Power estimates were based on a study of an 8-week RCT of cognitive training, physical 
exercise, and dietary education in patients with MCI (n = 57) and normal cognition (n = 62). The 
authors calculated a cognitive composite from the ADAS-Cog, Trail-Making Test B, Symbol Digit 
Modalities Test, and Category Fluency test, with z score differences between experimental and 
control groups being z = 0.25 at both 3- and 6-months post treatment. Based on this data, with 
our sample size we will have 90% power with a 2-sided α = 0.05 to detect effect size differences 
of 0.23 at 15-Week and 40-Week Post-Intervention Follow-Up visits. 
 
  
Specific Aim 1: Evaluate feasibility of a lifestyle intervention in participants with EOAD. 
Specific Aim 2: Investigate if a lifestyle intervention improves (2a) cognition and (2b) 
functioning and mood in participants with EOAD compared to an active control 
condition. 
Specific Aim 3: Explore potential moderators (training, clinical) on lifestyle intervention 
benefit. 

 
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Analysis: Although this preliminary study’s sample size is limited, the impact of moderators on 
training benefit will be examined as follows: linear mixed effect regression will be used to model 
longitudinal data including random effects for participants to examine the impact of training 
dose, sex, and disease severity on CANTAB performance between groups, with separate 
interaction models being applied (treatment assignment x training hours/sex/severity). 
 
 
Power: As indicated previously, the focus of Aim 3 will be on determining effect sizes and the 
magnitude of sample sizes needed for future work. We will not estimate the sizes of these 
effects as feasibility trials are underpowered for reliable estimates. 
 
All statistical analysis will be conducted with the Biostatistics Core Leader of LEADS, Ani 
Eloyan, PhD. 
 
 
13.0 
Privacy/Confidentiality Issues 
 
Data will be obtained from individually identifiable living human subjects in the form of 
demographic information, medical and psychiatric history, presence of memory and other 
cognitive complaints, report of activities of daily living, ratings of quality of life, performance on 
neuropsychological tests, and responses on a depression assessment and a brief stress 
measure. Most of this information will be collected during one-on-one virtual research visits with 
the participants. Information will also be collected from interviews with knowledgeable 
informants. LEADS records will be accessed to confirm diagnosis and incorporate demographic 
and clinical data into the LITES study. To facilitate access to LEADS records, Global Unique 
Identifiers (GUIDs) for all LITES participants will be acquired. Each GUID unambiguously 
identifies a research study participant across different research studies without exposing PHI. 
When investigators pool data together from multiple studies, GUIDs provide the means to detect 
participants who participate in more than one study. 
 
Data will be obtained specifically for research purposes and it will not be used for clinical or 
other purposes. Research data will only be accessible to members of the research team. To 
maintain privacy/confidentiality, study identification numbers will be created with a name-to-
identification number key stored in a separate document to reduce the likelihood of loss of 
confidentiality. Some research team members will have access to greater levels of individually 
identifiable information. For example, the research assistants who schedule visits, obtain 
consent, and collect cognitive test data will have access to the most identifiable information. 
Conversely, the biostatisticians will only have access to data that has already been largely de-
identified (e.g., identification numbers instead of names of participants). 
 
14.0 
Data Management 
 
Primary data will be collected via direct data capture from measurement instrument and stored 
electronically in REDCap. The storage location will be backed up automatically. Other data 
sources include data from the LEADS study that will be stored in separate electronic files and 
merged with the primary data as needed. Quality assurance steps will include: 1) built in range 
checks; and 2) testing of database by study team prior to moving to production mode. The 
following quality control method will be used: extraction and cleaning of data that will be used for 
analysis every 3 months. 
 
15.0 
Follow-up and Record Retention 
 

 
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For each participant, treatment will last approximately 14 weeks, followed by post-treatment 
follow-up at 15 Week and 40 Week Post-Intervention Follow-up visits. This will result in the 
length of involvement for a particular participant being approximately 11 months. The duration of 
the entire study will be six years. Records will be retained for seven years following the 
completion of the study, with paper records being shredded and electronic records being 
deleted at that time. 
 
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With Cognitive Function Among Older Black and White US Adults. JAMA Netw Open 
2023;6(3):e231860. 
55. 
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults 
with cognitive impairment. Psychosom Med 2002;64(3):510–519. 
56. 
Slavin V, Creedy DK, Gamble J . Single Item Measure of Social Supports: Evaluation of 
construct validity during pregnancy. J Affect Disord 2020;272:91-97 
57. 
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The Multidimensional Scale of Perceived 
Social Support. J Pers Assess 1988;52:30-41.  
 
 
 
17.0 
Appendix 
 
The Appendix includes materials that participants will receive regarding BrainHQ, CANTAB, 
Demographics Questionnaire, Anti-Amyloid Treatment Information Form, Cognitive Self-Report 
Questionnaire, ADCS-ADL, BDI-2, PSS-4, MSPSS-6, PCQ, Cognitive Training Satisfaction 
Survey, Exercise Satisfaction Survey, Self-Reported Off-Line Training Forms. 
 
BrainHQ Training 
 
The core battery of BrainHQ tasks are taken from the “Focus on Visual Process” 
schedule. This focus is designed to improve the speed and accuracy of visual 
processing, attention, and memory. The overall program is composed of five interrelated 
training exercises that in aggregate span the organization of visual perception and 
cognition from spatial frequency processing to visuo-spatial memory. The tasks include 
speed of processing time-order judgments, discrimination between pairs of like items, 
and sustained tracking of multiple objects that increase their complexity by progressively 
moving to more and more rapidly presented stimuli and greater memory loads.  
 
This Focus presents five exercises (Double Decision, Eye for Detail, Target Tracker, 
Hawk Eye, Visual Sweeps) that are delivered over 40 sessions. .  
 
The tables below describe more detailed aspects of the exercises (Table 1) as well as 
which exercises and stages are presented for each of the 40 sessions (Table 2).  
 
Table 1 
Commercial name 
~ levels per stage 
# of stages 
~ minutes per stage 
Eye for Detail 
6 
4 
18 
Double Decision 
6 
7 
18 
Target Tracker 
9 
7 
27 
Hawk Eye 
6 
10 
18 

 
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Visual Sweeps 
8 
7 
24 
 
 
Table 2 
session 
exercise name & stage number 
~ mins per session 
1 
Target Tracker 1, Double Decision 1 
24 
2 
Visual Sweeps 1, Eye for Detail 1 
30 
3 
Hawk Eye 1, Visual Sweeps 2 
30 
4 
Target Tracker 2, Eye for Detail 2 
45 
5 
Visual Sweeps 3, Double Decision 3 
42 
6 
Target Tracker 3, Hawk Eye 2 
45 
7 
Visual Sweeps 4, Eye for Detail 3 
42 
8 
Target Tracker 4, Double Decision 4 
45 
9 
Visual Sweeps 5, Hawk Eye 3 
42 
10 
Target Tracker 5, Eye for Detail 4 
45 
11 
Visual Sweeps 6, Double Decision 6 
42 
12 
Target Tracker 6, Hawk Eye 4 
45 
13 
Visual Sweeps 7, Eye for Detail 2 
42 
14 
Target Tracker 7, Double Decision 7 
45 
15 
Visual Sweeps 2, Hawk Eye 5 
42 
16 
Target Tracker 2, Eye for Detail 3 
45 
17 
Visual Sweeps 3, Double Decision 10 
42 
18 
Target Tracker 3, Hawk Eye 6 
45 
19 
Visual Sweeps 4, Eye for Detail 4 
42 
20 
Target Tracker 4, Double Decision 3 
45 
21 
Visual Sweeps 5, Hawk Eye 7 
42 
22 
Target Tracker 5, Eye for Detail 2 
45 
23 
Visual Sweeps 6, Double Decision 4 
42 
24 
Target Tracker 6, Hawk Eye 8 
45 
25 
Visual Sweeps 7, Eye for Detail 3 
42 
26 
Target Tracker 7, Double Decision 6 
45 
27 
Visual Sweeps 2, Hawk Eye 9 
42 
28 
Target Tracker 2, Eye for Detail 4 
45 
29 
Visual Sweeps 3, Double Decision 7 
42 
30 
Target Tracker 3, Hawk Eye 10 
45 
31 
Visual Sweeps 4, Eye for Detail 2 
42 
32 
Target Tracker 4, Double Decision 10 
45 
33 
Visual Sweeps 5, Hawk Eye 2 
42 
34 
Target Tracker 5, Eye for Detail 3 
45 
35 
Visual Sweeps 6, Double Decision 3 
42 
36 
Target Tracker 6, Hawk Eye 3 
45 
37 
Visual Sweeps 7, Eye for Detail 4 
42 
38 
Target Tracker 7, Double Decision 4 
45 
39 
Visual Sweeps 2, Hawk Eye 4 
42 
40 
Target Tracker 2, Eye for Detail 2 
45 

 
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CANTAB Connect Assessment Subtests 
 
Rapid Visual Information Processing (RVP)  
 
 
 
RVP is a sensitive tool for assessment of sustained attention. Single digits appear one at a time 
at a rate of 100 digits per minute. Subjects must detect a series of target sequences (e.g. 3-5-7) 
and touch a button when they see the last digit of a target sequence. Nine target sequences 
appear every 100 numbers. Performance on the RVP test has been shown to be associated 
with activation in a network of brain structures including the frontal and parietal lobes (Coull et 
al., 1995).  
 
Key outcome measures include RVP A prime, a signal detection measure of target sensitivity 
and RVP median response latency. 
 
Match to Sample Visual Search (MTS)  
 
 
 

 
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MTS assesses attention and visual searching, with a speed-accuracy trade-off. A complex 
visual pattern is shown in a box in the middle of the screen. After a brief delay, a number of 
similar patterns are shown in a circle of boxes around the edge of the screen. The subject must 
touch the one that matches the sample in the middle. The number of patterns to choose from 
varies across trials, but there is always only one which matches the center pattern.  
 
Paired Associates Learning (PAL)  
 
 
 
PAL assesses visual memory and new learning, and is a sensitive tool for accurate assessment 
of episodic memory. Boxes are displayed on the screen and open one by one in a randomized 
order to reveal patterns hidden inside. The patterns are then displayed in the middle of the 
screen, one at a time, and the subject must touch the box where the pattern was originally 
located. If the subject makes an error, the patterns are re-presented to remind the subject of 
their locations. Practice trials with fewer patterns are available to familiarize subjects with the 
test.   
 
Pattern Recognition Memory (PRM)  
 
 
 

 
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PRM is a measure of visual recognition memory. The subjects watch a series of 12 patterns 
appear, one at a time, on the screen. These patterns are designed so that they cannot be given 
verbal labels. In the recognition phase, the subject chooses which two patterns they have 
already seen before.  
 
Spatial Working Memory (SWM)  
 
 
 
SWM requires retention and manipulation of visuospatial information. This test has notable 
executive function demands, and measures strategy use as well as errors. The test begins with 
colored boxes being shown on the screen. The aim of this test is that, by touching the boxes 
and using a process of elimination, the subject should find one ‘token’ in each of the boxes and 
use them to fill up an empty column on the right-hand side of the screen. The key test 
instruction is that the computer will never hide a token in the same colored box, so once a token 
is found in a box the subject should not return to that box to look for another token. The color 
and position of the boxes used are changed from trial to trial to discourage the use of 
stereotyped search strategies. The key outcome measures for SWM include errors (touching 
boxes that have been found to be empty and revisiting boxes which have already been found to 
contain a token) and strategy, a measurement of executive function. 
 
Stockings of Cambridge (SOC)  
 
 

 
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SOC assesses spatial planning and requires individuals to use problem-solving strategies to 
match two sets of stimuli. The subject is shown two displays. In each of these displays, three 
stockings - containing three colored balls - are suspended from a beam. The two displays 
appear at the top and bottom of the screen. The balls are arranged in different patterns in each 
display. The subject must move the balls in the bottom display to copy the pattern shown in the 
top display. The balls are moved one at a time by selecting the required ball, then selecting the 
position to which it should be moved. The subject is instructed to make as few moves as 
possible to match the two patterns. In a distinct phase of the test, subjects are instructed to copy 
the moves the computer makes. These moves mimic the moves the subject made, and allow 
movement time to be discounted from thinking time measures.  
 
.  
 
Verbal Paired Associates (VPA)  
 
 
Verbal Paired Associates (VPA) is an assessment of associative and episodic memory in which 
the task is to learn a set of word-pairs. This is a verbal task, with stimuli presented auditorily, 
and responses spoken by the participant and scored automatically by the software. The difficulty 
of the task (i.e., the memorability of the word-pair items) has been carefully calibrated so that 
parallel forms of the test can be used in repeated testing. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Lifestyle Interventions in Early-Onset Alzheimer’s Disease 
Demographics Questionnaire 
 
1. First, Middle, and Last Name: ____________________________________ 
 
2. Full Name at Birth: _____________________________________________ 
 
3. City, State, and Country of Birth: _________________________ 
 
4. Date of Birth: _______ /_______ /____________  
 
5. Age: _________ years 
 
6. Sex:  Male      Female 
 
7. Handedness:  Left      Right 
 
8. Have you previously participated in a research study on brain health outside 
of LEADS?         Yes       No  
If yes, please specify which study: 
___________________________________________         
 
9.  How many YEARS of education have you COMPLETED? 
______________years   
(For example, if you graduated high school in the USA, it would be 12 
years)  
 
10. Approximately how many hours per week do you engage in cognitively 
stimulating activities? (e.g., card or board games, puzzles, Sudoku, 
meaningful conversation, crafts, etc.)  _________hours per week  
 
11. Approximately how many hours per week do you use a computer?     
________hours per week 
 
12. Do you consider yourself to be Hispanic or Latino?       Yes       No        
Decline 
 
13. Do you consider yourself to be: (Check all that apply)  
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                           Date of Visit: _______/_______/____________  
Study ID #: _____________                      
Has the patient signed informed consent?  YES       NO  STOP: DO NOT CONTINUE WITHOUT SIGNED INFORMED 
CONSENT   
      

 
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a. White/Caucasian                                                 
b. Black/African American                                     
c. Asian                                                                   
d. Native Hawaiian/Pacific Islander                        
e. American Indian/Alaskan Native                        
f. Other: (specify)________________________   
g. Decline                                                                
 
14. If you put more than one response for question 13, which do you consider 
to be your PRIMARY racial background?  
a. White/Caucasian                                                 
b. Black/African American                                     
c. Asian                                                                   
d. Native Hawaiian/Pacific Islander                        
e. American Indian/Alaskan Native                        
f. Other: (specify)________________________   
 
15. Is English your primary language?       Yes       No   
 
 If no, please specify your primary language: 
_______________________________ 
 
16. What is your marital status?     Single        Married         Divorced         
Widowed   
 
17. What is your current living situation? 
a. My Own Home                                                   
b. Independent Living Facility                                
c. Assisted Living Facility                                      
d. Other: (specify)________________________   
 
18. During your adult life, what has been the highest total gross ANNUAL 
income for your household from all sources (before taxes and deductions)? 
Please check one:  
a. Under $25,000                    
b. $25,001 to $49,999             
c. $50,000 to $74,999             
d. $75,000-$99,999                 
e. $100,000 to $149,999         
f. $150,000 and over              
 

 
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19. What is your employment status?      
Retired       Semi-Retired        Not Yet Retired 
 
Disabled 
 
20. During your adult life, what has been your primary occupation?  
_____________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Lifestyle Interventions for the Treatment of Early-Onset Alzheimer’s Disease 
Study 
Anti-Amyloid Treatment Information Form 
 
 
Did this participant receive an Anti-Amyloid treatment?  
 
 
No 
☐ 
 
Yes 
☐ 
If No, initial, date and line through the rest of this form.   
 
If Yes, did they receive Aducanumab? 
 
☐ Yes 
☐ No 
 
If yes, provide treatment start date, if known:  
            ______________________________ (YYYY – MM – DD) 
 
Provide treatment end date, if known:  
            ______________________________ (YYYY – MM – DD) 
☐ Check if missing or not applicable  
 
Dose of treatment: 
_____________________________ 
 
Unit of dose:  
☐ milligram (mg)/ milliliter (mL) 
☐ other 
 
If other, specify:  
             
______________________________ 
 
Frequency of treatment: 
☐ every 4 weeks  
☐ other 
 
If other, specify:  
             
______________________________ 
 
Study Staff Initials: _____________                                               Date of Visit: ____ /____/_______      
Study ID #: _____________     
  
    
                     Participant Initials: ____________       

 
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Page 32 of 65 
Route of treatment: 
☐ Intravenous (IV)  
☐ other 
 
If other, specify:  
             
______________________________ 
 
 
 
If Yes, did they receive Lecanemab? 
 
☐ Yes 
☐ No 
 
If yes, provide treatment start date, if known:  
            ______________________________ (YYYY – MM – DD) 
 
Provide treatment end date, if known:  
            ______________________________ (YYYY – MM – DD) 
☐ Check if missing or not applicable  
 
Dose of treatment: 
_____________________________ 
 
Unit of dose:  
☐ milligram (mg)/ milliliter (mL) 
☐ other 
 
If other, specify:  
             
______________________________ 
 
Frequency of treatment: 
☐ every 4 weeks  
☐ other 
 
If other, specify:  
             
______________________________ 
 

 
Version 7.0_09/09/2024  
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Route of treatment: 
☐ Intravenous (IV)  
☐ other 
 
If other, specify:  
             
______________________________ 
 
 
 
If Yes, did they receive Donanemab? 
 
☐ Yes 
☐ No 
 
If yes, provide treatment start date, if known:  
            ______________________________ (YYYY – MM – DD) 
 
Provide treatment end date, if known:  
            ______________________________ (YYYY – MM – DD) 
☐ Check if missing or not applicable  
 
Dose of treatment: 
_____________________________ 
 
Unit of dose:  
☐ milligram (mg)/ milliliter (mL) 
☐ other 
 
If other, specify:  
             
______________________________ 
 
Frequency of treatment: 
☐ every 4 weeks  
☐ other 
 
If other, specify:  
             
______________________________ 
 

 
Version 7.0_09/09/2024  
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Route of treatment: 
☐ Intravenous (IV)  
☐ other 
 
If other, specify:  
             
______________________________ 
 
Please provide any additional comments:  
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
_________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 7.0_09/09/2024  
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LITES - COGNITIVE SELF-REPORT QUESTIONNAIRE (CSRQ) 
INSTRUCTIONS: 
“Below is a list of statements about how you see your everyday thinking skills and feelings. 
Please read each one carefully and circle the response that would best describe you over the 
last two weeks, including today.” 
 
1.  I have felt I have a good 
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me   
     memory. 
 
 
1 
      2 
                  3                  4                     5                           0                    
CG1 
 
2. I have had difficulty  
      hearing conversations in         Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me             
      noisy places (e.g. in a  
 
5 
       4   
 
          3        2 
 
1 
 
        0 
                  
HR2 
      restaurant or crowded room). 
 
3. I have been happy 
 
Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply 
to me   
     overall.                          
 
      1 
                    2 
                  3                  4                     5                           0                                     
SL1 
 
4.  I have had difficulty  
         Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to 
me   
     remembering things that   
5 
       4   
 
          3        2 
 
1 
 
        0 
                  
CG3 
     people told me. 
 
5. I have felt  
                            Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to 
me   
     self-confident.                          
5 
       4   
 
          3        2 
 
1 
 
        0SL10 
6.  When I met someone new,     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
      I remembered their name    
1 
      2 
                  3                  4                     5                           0                   
CG5 
      later. 
                   
 
 
 
 
        
 
                                    
7. I have been in a bad  
    Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
       mood. 
 
 
5 
       4   
 
          3        2 
 
1 
 
        0                     
SL6 
 
 
8.  I have been able to think         Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me             
      quickly. 
 
 
1 
      2 
                  3                  4                     5                           0                           
SL2 
 
 
 
        
 
                                   
9. I have not been able to  
      remember grocery shopping    Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me             
      items unless I looked at the  
5 
       4   
 
          3        2 
 
1 
 
        0 
                  
CG4  
      shopping list.  
 
10. I couldn’t find the right  
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me   
     word in a conversation.   
 
5 
       4   
 
          3        2 
 
1 
 
        0 
 
      CG2 
 
11. I could hear what 
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me                        
      people said when they                      1 
      2 
                  3                  4                     5                           0                    
HR3 
      spoke softly or mumbled.                
 
Study Staff Initials: _____________                                           Date of Visit: _______/_______/____________ 
Study ID #: _____________     
  
  Participant Initials:____________                          

 
Version 7.0_09/09/2024  
Page 36 of 65 
12. I have felt unproductive.         Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to 
me 
 
 
 
 
5 
       4   
 
          3        2 
 
1 
 
        0                     
SL3 
 
 
 
 
 
 
13. I have lost my train of  
      Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
      thought.         
 
 
5 
 
       4   
 
          3  
2 
 
1 
 
        0 
                  CG8 
 
14. It has been easy for me             Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me              
      to organize activities. 
 
1 
      2 
                  3                  4                     5                           0                SL8: 
 
 
 
 
        
 
 
15. I could remember where       Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
       I left things. 
 
 
1 
      2 
                  3                  4                     5                           0                  
CG10 
 
 
16. I have said or done things       Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me           
      without considering the  
 
5 
       4   
 
          3        2 
 
1 
 
        0 
                 
CG7 
      consequences. 
 
17. I have had difficulty 
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
      hearing what people say   
5 
       4   
 
          3        2 
 
1 
 
        0 
                 
HR4 
      when they spoke quickly.    
 
18. Given the opportunity, 
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
      I engaged in activities 
 
1 
      2 
                  3                  4                     5                           0 SL4 
      with other people.                              
 
19. I have not been able to  
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me  
      remember numbers. 
 
5 
       4   
 
          3        2 
 
1 
 
        0 
                 
CG6 
 
20. I have been interested  
    Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
      in trying new things. 
 
1 
      2 
                  3                  4                     5                           0                  
SL5 
 
21. I have been able to                Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me     
       take-in/process  
            1  
        2 
        
        3                  4                     5                           0                   
SL7 
       information quickly.  
 
22. I have walked into a room     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me  
      and then forgotten why I   
5 
       4   
 
          3        2 
 
1 
 
        0 
                  
CG9 
      needed to go there.  
 
23. I have felt pessimistic.    
  Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
  
 
 
 
5 
       4   
 
          3        2 
 
1 
 
        0                   
SL9 
 
 
 
 
 
 
 
     
 
24. I have had trouble       
      Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me   
     hearing conversations  
      
5 
       4   
 
          3        2 
 
1 
 
        0 
     
 
      HR1 
     on the telephone. 
 
25. I slept well at night.   
     Almost Always    Often/Usually     Sometimes    Seldom      Hardly Ever      Does not apply to me 
 
 
 
 
1 
      2 
                  3                  4                     5                           0  
 
 

 
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ADCS – Activities of Daily Living Inventory 
Galasko, D., Bennett, D., Sano, M., Ernesto, E., Thomas, R., Grundman, M., and Ferris, S. Alzheimer’s Disease and Associated 
Disorders 1997; 11:S33--‐S39. 
Information source: 
 Participant Visit 
 Telephone Call 
 
INSTRUCTIONS: For each question, use the participant’s name where “{P}” appears. Before 
beginning, read the guidelines to the study partner. For instructions on completing the ADL 
please refer to the Administration Guidelines. 
 
1. Regarding eating, which best describes {P} usual performance during the past 4 weeks: 
3  ate without physical help, and used a knife 
2  used a fork or spoon, but not a knife, to eat 
1  used fingers to eat 
0  {P} usually or always was fed by someone else 
 
 
2. Regarding walking (or getting around in a wheelchair), in the past 4 weeks, which best 
describes his/her optimal performance: 
3  mobile outside of 
home without physical help 
2  mobile across a room 
without physical help 
1  transferred from 
bed to chair without help 
0  required physical 
help to walk or transfer 
 
 
3. Regarding bowel and bladder function at the toilet, which best describes his/her usual 
performance in the past 4 weeks: 3  did everything necessary without supervision or 
physical help 
2  needed supervision, but no physical help 
1  needed physical help, and was usually continent 
0  needed physical help, and was usually incontinent 
 
 
4. Regarding bathing, in the past 4 weeks, which best describes his/her 
usual performance: 3  bathed without reminding or 
physical help 
2  no physical help, but needed 
supervision/reminders to bathe completely 1  
needed minor physical help (e.g., with washing 

 
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Page 38 of 65 
hair) to bath completely 0  needed to be bathed 
completely 
 
 
5. Regarding grooming, in the past 4 weeks, which best describes his/her 
optimal performance: 3  cleaned and cut fingernails without 
physical help 
2  brushed or combed hair without physical help 
1  kept face and hands clean without physical help 
0  needed help for grooming of hair, face, hands, and fingernails 
 
 
 
6a. Regarding dressing, in the past 4 weeks, which best describes his/her usual performance when 
selecting his/her first set of clothes for the day: 
3  without 
supervision or 
physical help 2  
with supervision 
1  with physical help 
0  {P} did not select 
his/her clothes for the 
day 0  don’t know 
 
 
6b. Regarding physically getting dressed, which best describes his/her usual 
performance in the past 4 weeks: 4  dressed completely without supervision 
or physical help 
3  dressed completely with supervision, but without help 
2  needed physical help only for buttons, clasps, or shoelaces 
1  dressed without help if clothes needed 
no fastening or buttoning 0  always 
needed help, regardless of type of clothing 
0  don’t know 
 
7. Regarding telephone usage in the past 4 weeks, which best describes his/her highest level of performance: 
5  made calls after looking up numbers in white or yellow pages, or 
by dialing directory assistance 4  made calls only to well--‐known 
numbers, without referring to a directory or list 
3  made calls only to well--‐known numbers by using a directory, list, or 
pre--‐programmed numbers 2  answered the phone; did not make 
calls 
1  did not answer the phone, but 
spoke when put on the line 0  did 
not use telephone 
0  don’t know 

 
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8. During the past 4 weeks, did {P} watch television? 
 yes 
 no 
 don’t know 
 
If yes, ask all questions: 
8a. Did {P} usually select or ask for different programs or his/her favorite show? 
1  yes 
0  no 
0  don’t know 
 
8b. Did {P} usually talk about the content of a program while watching it? 
1  yes 
0  no 
0  don’t know 
 
8c. Did {P} usually talk about the content of a program within a day (24 hours) after watching 
it? 
1  yes 
0  no 
0  don’t know 
 
 
9. During the past 4 weeks, when {P} appeared to be paying attention to conversation or small talk 
for at least 5 minutes, which best describes his/her usual degree of participation: 
NOTE: {P} did not need to initiate the conversation. 
3  usually said things that were related to the topic 
2  usually said things that 
were not related to the topic 1 
 rarely or never spoke 
0  did not participate in 
conversations or small talk 0 
 don’t know 
 
 
10. During the past 4 weeks, which best describes how {P} usually cleared dishes from the table 
after a meal or snack: 3  without supervision or help 
2  with supervision 1  with physical help 
0  {P} did not clear dishes 
0  don’t know 
 
11. During the past 4 weeks, which best describes how {P} usually managed to find his/her 

 
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personal belongings at home: 3  without supervision or help 
2  with supervision 1  with physical help 
0  {P} did not find personal belongings 0  don’t know 
 
 
12. During the past 4 weeks, which best describes {P}’s highest level of performance when 
obtaining a hot or cold beverage for him/herself: 
3  made a hot beverage, usually without physical help 
2  made a hot beverage, usually if 
someone else heated the water 1  
obtained a cold beverage, usually without 
physical help 
0  {P} did not obtain a 
beverage for him/herself 0 
 don’t know 
 
 
13. During the past 4 weeks, which best describes {P}’s highest level of performance when making 
him/herself a meal or snack at home: 
4  cooked or microwaved 
food, with little or no help 3  
cooked or microwaved food, 
with extensive help 
2  mixed or combined food items for a meal or snack, without cooking or 
microwaving (e.g. made a sandwich) 1  obtained food on his/her own, without 
mixing or cooking it 
0  {P} did not make him/herself 
a meal or snack at home 0  
don’t know 
 
14. During the past 4 weeks, which best describes how {P} usually disposed of garbage or litter in 
the appropriate place or container at home: 
3  without supervision or help 2  with supervision 
1  with physical help 
0  {P} did not dispose of garbage or litter in an 
appropriate place or container 0  don’t know 
 
 
15. During the past 4 weeks, which best describes {P}’s optimal performance when getting around 
(or traveling) outside of his/her home: 
4  alone, went at least 1 mile away from home 3  alone, but remained within 1 mile of home 
2  only when accompanied and supervised regardless of the trip 1  only with physical 
help regardless of the trip 
0  {P} did not get around (or travel) outside of his/her home 0  don’t know 

 
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16a. On shopping trips during the past 4 weeks, which best describes how {P} 
usually selected items: 3  without supervision or physical help 
2  with some supervision or physical help 
1  not at all, or selected mainly 
random or inappropriate items 0  {P} 
did not go shopping 
0  don’t know 
 
 
16b. On shopping trips during the past 4 weeks, did {P} usually pay for items without supervision or physical 
help? 
1  yes 
0  no 
0  {P} did not go shopping 0  don’t know 
 
 
17. During the past 4 weeks, when keeping appointments or meetings with other people such as 
relatives, a doctor, the hairdresser, etc., which best describes {P}’s awareness of the appointment 
or meeting ahead of time: 
3  usually remembered, may have needed written reminders, 
e.g., notes, a diary, or calendar 2  only remembered the 
appointment after verbal reminders on the day 
1  usually did not remember, in spite of 
verbal reminders on the day 0  {P} did not 
keep any appointments or meetings 
0  don’t know 
 
 
18. During the past 4 weeks, was {P} ever left on his/her own? 
NOTE: Being taken to day care or having a sitter at home does not constitute being left alone. 
 yes 
 no 
 don’t know 
 not applicable -‐‐ {P} is institutionalized 
 
If yes, ask all questions: 
18a. Was {P} left away from home, for 15 minutes or longer, during the day? 
1  yes 
0  no 
0  don’t know 
 

 
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18b. Was {P} left at home, for an hour or longer, during the day? 
1  yes 
0  no 
0  don’t know 
 
18c. Was {P} left at home, for less than 1 hour, during the day? 
1  yes 
0  no 
0  don’t know 
 
19. During the past 4 weeks, did {P} talk about current events? 
NOTE: This means events or incidents that occurred during the past month. 
 yes 
 no 
 don’t know 
 
If yes, ask all questions: 
 
19a. Did {P} talk about events that he/she heard or read about or saw on TV but did not take 
part in? 
1  yes 
0  no 
0  don’t know 
 
19b. Did {P} talk about events that he/she took part in outside home involving family, friends, 
or neighbors? 
1  yes 
0  no 
0  don’t know 
 
19c. Did {P} talk about events that occurred at home that he/she took part in or watched? 
1  yes 
0  no 
0  don’t know 
 
20a. Did {P} usually talk about details of what he/she read while or shortly (less than 1 hour) after 
reading? 
1  yes 
0  no 
0  don’t know 
 
20b. Did {P} usually talk about what he/she read 1 hour or longer after reading? 

 
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1  yes 
0  no 
0  don’t know 
 
21. During the past 4 weeks, which best describes the most complicated things 
that {P} wrote down: 3  letters or long notes that other people 
understood 
2  short notes or messages that other people understood 1  his/her signature or name 
0  {P} did not write things down 0  don’t know 
 
22. During the past 4 weeks, which best describes how {P} usually performed his/her most 
common pastime, hobby, or game: 
NOTE: Walking does not count as a pastime/hobby for this scale. 
Examples include card or board games (including bridge, chess, checkers), bingo, crosswords, 
art, musical instrument, knitting, sewing, reading, gardening, golf, tennis, workshop, fishing. 
3  without supervision 
or help 2  with 
supervision 
1  with physical help 
0  {P} did not perform any 
pastimes, hobbies, or games 0  
don’t know 
 
If {P} performed hobbies/pastimes, were they performed only at day care? 
 yes 
 no 
 
 
23. Regarding the use of a household appliance to do chores during the past 4 weeks, which best 
describes how {P} usually used the most common appliances: 
NOTE: This does not include a TV. Examples include washer, dryer, vacuum, dishwasher, toaster, 
toaster oven, range, microwave, food processor. 
4  without help, operating more than on--‐off controls if needed 3  without help, but operated only 
on--‐off controls 
2  with supervision, but no physical help 1  with physical help 
0  {P} did not use a household appliance to do chores 0  don’t know 
 
Galasko, D., Bennett, D., Sano, M., Ernesto, E., Thomas, R., Grundman, M., and Ferris, S. Alzheimer Disease and Associated Disorders 1997; 
11:S33--‐S39. 
Last modified: 23 July 2014 
Page 6 of 6 
 
 

 
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Beck's Depression Inventory- 2 
 
1. 
0 I do not feel sad. 
1 I feel sad 
2 I am sad all the time and I can't snap out of it. 
3 I am so sad and unhappy that I can't stand it. 
 
2. 
0 I am not particularly discouraged about the future. 
1 I feel discouraged about the future. 
2 I feel I have nothing to look forward to. 
3 I feel the future is hopeless and that things cannot improve. 
 
3. 
0 I do not feel like a failure. 
1 I feel I have failed more than the average person. 
2 As I look back on my life, all I can see is a lot of failures. 
3 I feel I am a complete failure as a person. 
 
4. 
 0 I get as much satisfaction out of things as I used to. 
 1 I don't enjoy things the way I used to. 
 2 I don't get real satisfaction out of anything anymore. 
 3 I am dissatisfied or bored with everything. 
 
5. 
 0 I don't feel particularly guilty 
 1 I feel guilty a good part of the time. 
 2 I feel quite guilty most of the time. 
 3 I feel guilty all of the time. 
 
6. 
 0 I don't feel I am being punished. 
 1 I feel I may be punished. 
 2 I expect to be punished. 
 3 I feel I am being punished. 
 
7. 
 0 I don't feel disappointed in myself. 
 1 I am disappointed in myself. 
 2 I am disgusted with myself. 
 3 I hate myself. 
 
8. 
 0 I don't feel I am any worse than anybody else. 
 1 I am critical of myself for my weaknesses or mistakes. 
 2 I blame myself all the time for my faults. 
 3 I blame myself for everything bad that happens. 
 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                Date of Visit: _______/_______/____________  
Study ID #: _____________                                                              

 
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9. 
 0 I don't have any thoughts of killing myself. 
 1 I have thoughts of killing myself, but I would not carry them out. 
 2 I would like to kill myself. 
 3 I would kill myself if I had the chance. 
 
10. 
 0 I don't cry any more than usual. 
 1 I cry more now than I used to. 
 2 I cry all the time now. 
 3 I used to be able to cry, but now I can't cry even though I want to. 
 
11. 
 0 I am no more irritated by things than I ever was. 
 1 I am slightly more irritated now than usual. 
 2 I am quite annoyed or irritated a good deal of the time. 
 3 I feel irritated all the time. 
 
12. 
 0 I have not lost interest in other people. 
 1 I am less interested in other people than I used to be. 
 2 I have lost most of my interest in other people. 
 3 I have lost all of my interest in other people. 
 
13. 
 0 I make decisions about as well as I ever could. 
 1 I put off making decisions more than I used to. 
 2 I have greater difficulty in making decisions more than I used to. 
 3 I can't make decisions at all anymore. 
 
14. 
 0 I don't feel that I look any worse than I used to. 
 1 I am worried that I am looking old or unattractive. 
 2 I feel there are permanent changes in my appearance that make me look 
 unattractive 
 3 I believe that I look ugly. 
 
15. 
 0 I can work about as well as before. 
 1 It takes an extra effort to get started at doing something. 
 2 I have to push myself very hard to do anything. 
 3 I can't do any work at all. 
 
16. 
 0 I can sleep as well as usual. 
 1 I don't sleep as well as I used to. 
 2 I wake up 1-2 hours earlier than usual and find it hard to get back to sleep. 
 3 I wake up several hours earlier than I used to and cannot get back to sleep. 
 
17. 
 0 I don't get more tired than usual. 

 
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 1 I get tired more easily than I used to. 
 2 I get tired from doing almost anything. 
 3 I am too tired to do anything. 
 
18. 
 0 My appetite is no worse than usual. 
 1 My appetite is not as good as it used to be. 
 2 My appetite is much worse now. 
 3 I have no appetite at all anymore. 
 
19. 
 0 I haven't lost much weight, if any, lately. 
 1 I have lost more than five pounds. 
 2 I have lost more than ten pounds. 
 3 I have lost more than fifteen pounds. 
 
20. 
 0 I am no more worried about my health than usual. 
 1 I am worried about physical problems like aches, pains, upset stomach, or constipation. 
 2 I am very worried about physical problems and it's hard to think of much else. 
 3 I am so worried about my physical problems that I cannot think of anything else. 
 
21. 
 0 I have not noticed any recent change in my interest in sex. 
 1 I am less interested in sex than I used to be. 
 2 I have almost no interest in sex. 
 3 I have lost interest in sex completely. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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FOR STUDY STAFF USE ONLY: 
 
Study Staff Initials:   
 
Date of Visit: 
/ 
/  
 
Study ID #:   
 
 
 
Perceived Stress Scale 4 (PSS-4) 
Instructions: The questions in this scale ask you about your feelings & thoughts during the last 
month. In each case, please indicate your response by selecting the option representing how 
often you felt or thought a certain way.  
                                                                                                                                         Never     Almost Never    Sometimes   Fairly Often    Very Often                             
                                                                                               0                1                     2                 3                  4 
                       
1. In the last month, how often have you felt 
that you were unable to control the                  ☐           ☐              ☐             ☐            ☐ 
              important things in your life?  
 
2. In the last month, how often have you felt 
confident about your ability to handle your     ☐           ☐              ☐             ☐            ☐ 
personal problems?  
 
3. In the last month, how often have you felt 
that things were going your way?                      ☐           ☐              ☐             ☐            ☐ 
 
4. In the last month, how often have you felt 
difficulties were piling up so high that you       ☐           ☐              ☐             ☐            ☐ 
could not overcome them? 
 
 
Scoring for the Perceived Stress Scale 4:  
 
Instructions: Total score is determined by adding together the scores of each of the 4 items. 
Questions 2 and 3 are reverse coded.  
 
Questions 1 and 4: 
 
 
Questions 2 and 3:  
0 = Never 
 
 
 
4 = Never 
1 = Almost Never  
 
 
3 = Almost Never 
2 = Sometimes 
 
 
 
2 = Sometimes 
3 = Fairly Often  
 
 
1 = Fairly Often 
4 = Very Often 
 
 
 
0 = Very Often 
 
Lowest score: 
 0 
Highest score: 
16  
 
   Higher scores are correlated to more stress. 

 
Version 7.0_09/09/2024  
Page 48 of 65 
FOR STUDY STAFF USE ONLY: 
 
Study Staff Initials:   
 
Date of Visit: 
/ 
/  
 
Study ID #:   
 
15 Week Follow Up 
 
 
Lifestyle Interventions for the Treatment of Early-Onset 
Alzheimer’s Disease Study 
Perceptions of Change Questionnaire 
 
Please circle the response that best matches how you feel about the following 
statements: 
 
1. The training program helped improve my memory. 
 
 
Strongly 
Agree 
Agree 
Neutral 
Disagree 
Strongly 
Disagree 
 
2. The training program helped improve my overall thinking abilities. 
 
 
Strongly 
Agree 
Agree 
Neutral 
Disagree 
Strongly 
Disagree 
 
3. I enjoyed the training program overall. 
 
 
Strongly 
Agree 
Agree 
Neutral 
Disagree 
Strongly 
Disagree 
 
 
4. Do you think you were assigned to the experimental or control 
group? (Circle one) 
 
Experimental 
Don’t Know 
Control 
 
 
 
 

 
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Lifestyle Interventions for the Treatment of Early-Onset AD Study (LITES) 
Cognitive Training Satisfaction Survey and Questionnaire 
 
Survey: 
INSTRUCTIONS: 
“Below is a list of statements or questions about your experience with the 
Cognitive Training Intervention. Please read each one carefully and circle the 
response that would best describe your feeling during the training period.” 
 
 
1.  I found the online program  
Strongly Agree     
Agree        Neutral     
       Disagree       
Strongly Disagree 
     easy to navigate       
 
 
 
 
 
 
2. I found the exercises challenging 
Strongly Agree     
Agree        Neutral     
       Disagree       
Strongly Disagree 
     but enjoyable 
 
 
 
 
 
 
 
3. I found the intensity of the  
Strongly Agree     
Agree        Neutral     
       Disagree       
Strongly Disagree 
    cognitive training program  
    appropriate and manageable 
 
 
 
 
4. How helpful did you find the  
 
      Extremely 
Very  
           Moderately            Little 
       
    cognitive training program to 
 
        Helpful 
          Helpful     
   Helpful      
         Helpful 
            
Not at All Helpful     
    improve your brain health overall?   
 
 
 
 
5. Overall, how satisfied were you 
      Extremely        Somewhat    Neither Satisfied       Somewhat             Extremely 
    with the cognitive training program?           Satisfied 
          Satisfied       nor Dissatisfied       Dissatisfied      Dissatisfied     
 
 
 
 
Additional User Questions: 
 
1. Which of the following prevented you from using the cognitive training program 
(check all that apply): 
 
 I did not have easy access to a computer with internet 
 
 I did not understand how to use a computer well 
 
 I did not understand how to use the training program 
 
 I found the training program too frustrating 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                                       Date of Visit: 
_______/_______/____________  
Study ID #: _____________                                                                                     Week 15 Follow-Up 

 
Version 7.0_09/09/2024  
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 I did not have enough time to complete the training program 
 
 I did not want to do the training program 
 
 I did not believe the training program was helping me 
 
 I found the training program boring 
 
 I found the training program annoying 
 
 Nothing prevented me from using the training program 
 
 Other (Specify):__________________________________________________ 
 
 
2. What do you think could improve the cognitive training program (check all that 
apply)? 
 
 More thorough instructions in the program 
 
 More thorough paper instructions to take home 
 
 Take away the sounds and animations not necessary to the exercises 
 
 Add more sounds and animations to provide feedback 
 
 I like the training program the way it is 
 
 Other __________________________________________________________ 
 
3. Which browser did you normally use to access the cognitive training program?  
 
 Internet Explorer (IE)  
 
 Mozilla Firefox    
 
 Safari  
 
 Google Chrome  
 
 Other:________________________________________________________ 

 
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4. When using the cognitive training program, did you normally use a: 
 
 Mouse 
 
 Track pad  
 
 Touchscreen  
 
 Other:____________________________________________________ 
 
 
 
 
 
Modified from:  
Li, F., Harmer, P., Fitzgerald, K. et al. A cognitively enhanced online Tai Ji Quan training 
intervention for community-dwelling older adults with mild cognitive impairment: A 
feasibility trial. BMC Geriatr 22, 76 (2022). https://doi.org/10.1186/s12877-021-02747-0 
 
 
 
 
 
 
 
 
 
 
 

 
Version 7.0_09/09/2024  
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Lifestyle Interventions for the Treatment of Early-Onset AD Study 
(LITES) 
Exercise Satisfaction Survey 
 
INSTRUCTIONS: 
“Below is a list of statements or questions about your experience with the 
Exercise Intervention. Please read each one carefully and circle the response that 
would best describe your feeling during the training period.” 
 
1.  I found the exercise program 
 
Strongly Agree     
Agree      
  Neutral            Disagree       
Strongly Disagree 
     safe to practice 
      
 
 
 
 
 
 
2. I found the exercises challenging 
Strongly Agree     
Agree      
  Neutral            Disagree       
Strongly Disagree 
     but enjoyable 
 
 
 
 
 
 
 
3. I found the intensity of the 
 
Strongly Agree     
Agree      
  Neutral            Disagree       
Strongly Disagree 
    exercise program appropriate  
    and manageable 
 
 
 
 
4. How helpful did you find the  
 
      Extremely 
Very  
           Moderately 
           Little 
       
    exercise program to improve 
 
        Helpful                Helpful     
              Helpful      
         Helpful 
   Not at All Helpful     
    your brain health overall?   
 
 
 
 
5. Overall, how satisfied were you       Extremely        Somewhat    Neither Satisfied       Somewhat             Extremely 
    with the exercise program?       
       Satisfied 
          Satisfied       nor Dissatisfied       Dissatisfied 
      Dissatisfied     
 
 
 
 
Modified from:  
Li, F., Harmer, P., Fitzgerald, K. et al. A cognitively enhanced online Tai Ji Quan training 
intervention for community-dwelling older adults with mild cognitive impairment: A 
feasibility trial. BMC Geriatr 22, 76 (2022). https://doi.org/10.1186/s12877-021-02747-0 
 
 
 
 
 
 
 
 
 
 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                                       Date of Visit: 
_______/_______/____________  
Study ID #: _____________                                                                                     Week 15 Follow-Up 
Questionnaire      

 
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Self-Reported Off-Line Training 
BASELINE 
 
Now I have some questions about your activities in the last 3 months (i.e., prior to the start of 
training). In the last 3 months…. 
1. Did you visit a YMCA, health club, gym, or wellness center?  
 
 
YES…………..1            
NO…………..0   
[SKIP TO #2] 
 
1A. Name of club/center: _______________________________________ 
 
1B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
2. Did you take a class for exercise, swimming, yoga, or Tai Chi (i.e., structured group led by 
an instructor)?  
[Note: Do NOT include prescribed physical therapy] 
 
YES…………..1            
NO…………..0   
[SKIP TO #3]  
 
2A. Type of class: _______________________________________ 
 
2B. Frequency of attendance (on average):  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3. Did you take an adult education course, such as a continuing education course at a local 
university or community college?        
 
 
YES…………..1           
NO…………..0   
[SKIP TO #4] 
 
3A. Course matter/subject: _______________________________________ 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                            Date of Visit: 
_______/_______/____________  
Study ID #: _____________                                                                                     Baseline      

 
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3B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3C. Length/Duration of course:  
__ __ months  
 
    
4. Did you participate in any brain exercise program or training (i.e, web-based, in-person, 
DVD)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #5] 
 
4A. Name of program: _______________________________________ 
 
4B. Frequency of participation:  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4 
 
 
5. Did you participate in any cognitively stimulating activities (e.g., card or board games, 
puzzles, Sudoku, crafts, etc.)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #6] 
 
5A. Name of activity: _______________________________________ 
 
5B. Frequency of participation:  
< 1 day per week or discontinued after brief 
engagement.. 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4 
 
6. Approximately how many hours per week on average do you use a computer?     
  
≤ 1 hour per week..
 
1 

 
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2-5 hours per week
 
2 
 
6-13 hours per week
 
3 
 
14+ hours per week
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Page 56 of 65 
Self-Reported Off-Line Training  
15 WEEK POST INTERVENTION FOLLOW UP 
 
Now I have some questions about your activities in the last 14-15 weeks (i.e., since training 
began). In the last 15 weeks…. 
1. Did you visit a YMCA, health club, gym, or wellness center?  
 
 
YES…………..1            
NO…………..0   
[SKIP TO #2] 
 
1A. Name of club/center: _______________________________________ 
 
1B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
2. Did you take a class for exercise, swimming, yoga, or Tai Chi outside of this research project 
(i.e., structured group led by an instructor)?  
[Note: Do NOT include prescribed physical therapy] 
 
YES…………..1            
NO…………..0   
[SKIP TO #3]  
 
2A. Type of class: _______________________________________ 
 
2B. Frequency of attendance (on average):  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3. Did you take an adult education course, such as a continuing education course at a local 
university or community college?        
 
 
YES…………..1           
NO…………..0   
[SKIP TO #4] 
 
3A. Course matter/subject: _______________________________________ 
 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                            Date of Visit: 
_______/_______/____________  
Study ID #: _____________                                                                                     15 Week Follow Up      

 
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3B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3C. Length/Duration of course:  
__ __ months  
 
  
4. Did you participate in any brain exercise program or training outside of this research project 
(i.e, web-based, in-person, DVD)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #5] 
 
4A. Name of program: _______________________________________ 
 
4B. Frequency of participation:  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4 
5. Did you participate in any cognitively stimulating activities outside of this research project 
(e.g., card or board games, puzzles, Sudoku, crafts, etc.)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #6] 
 
5A. Name of activity: _______________________________________ 
 
5B. Frequency of participation:  
< 1 day per week or discontinued after brief 
engagement.. 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
5-7 days per week
 ...................................................................
4 
 
6. At any time during your participation in this study, did you participate in any other research? 
YES…………..1            
NO…………..0   
[SKIP TO #7] 
 
What was the project?  
_____________________________________________________________ 
 

 
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Page 58 of 65 
 
If yes, when did you participate in the project?  
__________________________________________ 
 
7. Outside of this research project, approximately how many hours per week on average do you 
use a computer?     
  
≤ 1 hour per week..
 
1 
 
2-5 hours per week
 
2 
 
6-13 hours per week
 
3 
 
14+ hours per week
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 7.0_09/09/2024  
Page 59 of 65 
 
Self-Reported Off-Line Training  
40 WEEK FOLLOW-UP 
 
Now I have some questions about your activities in the last 6 months (i.e., since the end of 
training). In the last 6 months…. 
1. Did you visit a YMCA, health club, gym, or wellness center?  
 
 
YES…………..1            
NO…………..0   
[SKIP TO #2] 
 
1A. Name of club/center: _______________________________________ 
 
1B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
2. Did you take a class for exercise, swimming, yoga, or Tai Chi outside of this program (i.e., 
structured group led by an instructor)?  
[Note: Do NOT include prescribed physical therapy] 
 
YES…………..1            
NO…………..0   
[SKIP TO #3]  
 
2A. Type of class: _______________________________________ 
 
2B. Frequency of attendance (on average):  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3. Did you take an adult education course, such as a continuing education course at a local 
university or community college?        
 
 
YES…………..1           
NO…………..0   
[SKIP TO #4] 
 
3A. Course matter/subject: _______________________________________ 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                            Date of Visit: 
_______/_______/____________  
Study ID #: _____________                                                                          40 Week Follow Up      

 
Version 7.0_09/09/2024  
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3B. Frequency of attendance (on average): 
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4  
 
3C. Length/Duration of course:  
__ __ months  
 
  
4. Did you participate in any brain exercise program or training outside of this program (i.e, 
web-based, in-person, DVD)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #5] 
 
4A. Name of program: _______________________________________ 
 
4B. Frequency of participation:  
< 1 day per week or discontinued after trivial 
exposure 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
 
5-7 days per week
 
4 
 
5. Did you participate in any cognitively stimulating activities outside of this research project 
(e.g., card or board games, puzzles, Sudoku, crafts, etc.)? 
 
YES…………..1            
NO…………..0   
[SKIP TO #6] 
 
5A. Name of activity: _______________________________________ 
 
5B. Frequency of participation:  
< 1 day per week or discontinued after brief 
engagement.. 
1 
 
1-2 days per week
 
2 
 
3-4 days per week
 
3 
5-7 days per week
 ...................................................................
4 
 
6. At any time during your participation in this study, did you participate in any other research? 
YES…………..1            
NO…………..0   
[SKIP TO #7] 
 

 
Version 7.0_09/09/2024  
Page 61 of 65 
What was the project?  
_____________________________________________________________ 
 
 
If yes, when did you participate in the project?  
__________________________________________ 
 
 
7. Outside of this research project, approximately how many hours per week on average do you 
use a computer?     
  
≤ 1 hour per week..
 
1 
 
2-5 hours per week
 
2 
 
6-13 hours per week
 
3 
 
14+ hours per week
 
4 
 
 
 
 
 
 
 
 
 
 

 
Version 7.0_09/09/2024  
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Version 7.0_09/09/2024  
Page 63 of 65 
 
Multidimensional Scale of Perceived Social Support 6 (MSPSS-6) 
 
Instructions: We are interested in how you feel about the following statements. Read each 
statement carefully. Indicate how you feel about each statement. 
 
Circle the “1” if you Very Strongly Disagree 
Circle the “2” if you Strongly Disagree 
Circle the “3” if you Mildly Disagree 
Circle the “4” if you are Neutral 
Circle the “5” if you Mildly Agree 
Circle the “6” if you Strongly Agree 
Circle the “7”  if you Very Strongly Agree 
 
.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very 
Strongly 
Disagree 
Strongly 
Disagree 
Mildly 
Disagree 
Neutral 
Mildly 
Agree 
Strongly 
Agree 
Very 
Strongly 
Agree 
1. There is a special person with 
whom I can share joys and sorrows. 
1 
2 
3 
4 
5 
6 
7 
2. There is a special person who is 
around when I am in need. 
1 
2 
3 
4 
5 
6 
7 
3. I can count on my friends when 
things go wrong. 
1 
2 
3 
4 
5 
6 
7 
4. I can talk about my problems with 
my friends. 
1 
2 
3 
4 
5 
6 
7 
5. I get the emotional help and support 
I need from my family. 
1 
2 
3 
4 
5 
6 
7 
6. My family really tries to help me. 
1 
2 
3 
4 
5 
6 
7 
Study Staff Initials: _____________                                               Date of Visit: ____ /____/_______      
Study ID #: _____________     
  
    
                     Participant Initials: ____________       

 
Version 7.0_09/09/2024  
Page 64 of 65 
 
Lifestyle Interventions in Early-Onset Alzheimer’s Disease Study 
Contact Information 
 
1. Participant’s Name: ____________________________________________ 
 
2. Preferred Name:____________________________________ 
 
3. Preferred Phone Number:____________________________ Home   
Cell     Other      
 
Alternate Phone Number: :___________________________ Home   
Cell     Other 
 
4. Best Time to Call: ______________________________________ 
 
5. Mailing Address: _____________________________________________ 
                                       _____________________________________________ 
 
6. E-Mail Address: 
________________________________________________ 
 
7. Preferred Method of Contact:   E-Mail    Phone    Mail    
Other:______________ 
 
8. Name of Study Partner: 
____________________________________________________ 
 
9. Study Partner’s Relationship to You: 
_________________________________________ 
 
10. Email Address of Study Partner: 
____________________________________________ 
 
11. Phone Number of Study Partner:_______________________ Home   
Cell    Other     
 
FOR STUDY STAFF USE ONLY: 
Study Staff Initials: _____________                                                 Date of Visit: _______/_______/____________  

 
Version 7.0_09/09/2024  
Page 65 of 65 
12. Best Time to Call Study 
Partner:___________________________________________ 
 
I authorize the research team to contact my study partner and inquire about me, 
as outlined in the Consent and Authorization Document. 
 
 
 
_________ (Initial Here)  
 
13. After the conclusion of this study, would you be interested in hearing about 
other research opportunities at our center?  Yes     No