Community-based Brain Health Program to Address Dementia Risk

Study Overview
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Brief Summary
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This is a validation study to evaluate the acceptability, feasibility and preliminary efficacy of the Brain Health Program, a multimodal curriculum covering dementia risk factors and evidence-based change interventions. The goal of this study is to evaluate the Brain Health Program in individuals with identified risk factors for the onset of dementia and to prepare for a large-scale efficacy trial in this population.

Detailed Description
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This study will employ an evidence-based Brain Health Program curriculum, which involves a twelve-week, group-administered, personalized program designed to improve brain health in individuals with identified risk factors for the onset of dementia. This is a single-arm open-label feasibility study, enrolling older adults with Alzheimer's disease risk factors in a public health, community-deployed, group-based and individualized multimodal Brain Health Program (targeting, among other domains, diet, exercise and cognitive exercise), with a set of baseline assessments intended to characterize the population, and outcome measure to evaluate the usability of the program, as well as preliminary efficacy to reduce dementia risk factors.

Official Title
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Community-based Brain Health Program to Address Dementia Risk

Conditions
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Dementia, Alzheimer Disease

Intervention / Treatment
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* Other: Brain Health Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are 65 years of age or older. Participants who meet criteria for one or more ADRD dementia risk factors Family history of Alzheimer's dementia (1st degree relative) Genetic marker (APOE4++) Subjective or objective cognitive decline (neuropsychological testing; or self-reported yes to the following question: In the past two years, have you experienced a decline in your memory or thinking? Poorly controlled hypertension or diabetes Physical inactivity <150min/week per Surgeon General guidelines Social isolation, in which participant rarely or never gets social and emotional support when needed Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments. Participants have access to an internet accessible device (eg. laptop, desktop computer, tablet or smartphone) Participants are able to attend all 12 classes (once a week for 12 weeks) and make up missed classes, as needed Participants are able to travel to/from YMCA location, if they choose to be a part of the in-person group Exclusion Criteria: Inability to provide informed consent Cognitive Abilities Screening Instrument - Short (CASI-Short) scores ≤ 25 (suggestive of cognitive impairment) Participants with untreated psychiatric conditions, including substance abuse/dependence disorders. Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Health Program<br>A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. | Other: Brain Health Program<br>* The Brain Health Program employs 1-hour/week group-based training and education regarding modifiable Alzheimer's disease dementia risk factors delivered over a 12-week period. Participants will be assigned into a group of up to 20 participants, and participants will engage the Brain Health Program collaboratively, as administered by the program content leader (instructor), while also being monitored and supported by the tech leader (in accordance with the Diabetes Prevention Program model).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Promoter Score | The scoring for this answer is based on a 0 to 10 scale. Those who respond with a score of 9 to 10 are called Promoters, and are considered likely to exhibit value-creating behaviors, such as making more positive referrals to other potential program participants. Those who respond with a score of 0 to 6 are labeled Detractors, and they are believed to be less likely to exhibit the value-creating behaviors. Responses of 7 and 8 are labeled Passives, and their behavior falls between Promoters and Detractors. The Net Promoter Score is calculated by subtracting the percentage of customers who are Detractors from the percentage of customers who are Promoters. For purposes of calculating a Net Promoter Score, Passives count toward the total number of respondents, thus decreasing the percentage of detractors and promoters and pushing the net score toward 0. | At 12 weeks |