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Completed

NCT Number: NCT05529706

Community-based Brain Health Program to Address Dementia Risk

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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YMCA of San Francisco

San Francisco, California, 94105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or Spanish 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.
  • Participants presently attending classes or courses like this program that is focused on dementia risk and behavior management.

Treatment and study plan

Brain Health Program

Other

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).

Primary outcomes

  1. Net Promoter Score

    Time frame: At 12 weeks

    NPS (Net Promoter Score) is a whole number on a scale of -100 to +100, calculated by subtracting the percentage of Detractors from the percentage of Promoters. Promoters (score 9-10) are likely to exhibit value-creating behaviors, such as referring other potential program participants. Detractors (score 0-6) are less likely to do so. Passives (score 7-8) fall in between. Passives count toward the total number of respondents, which decreases the percentage of Promoters and Detractors and pushes the score toward 0. Higher score is better.

Secondary outcomes

  1. Percentage of Participants Who Complete at 80% of Intended Program Sessions.

    Time frame: At 12 weeks

  2. Program Comprehension

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the program was easy to comprehend. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

  3. Relevancy of Program

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the program was relevant. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

  4. Program Awareness

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the program effectively raised awareness about brain health and how to manage it. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

  5. Program Work Assignments

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the work assigned in the program was reasonable. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

  6. Positive Lifestyle Change Post-program

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the program helped to make a positive lifestyle change. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

  7. Program Satisfaction

    Time frame: At 12 weeks

    One of the post-program survey questions asked participants whether the program was satisfying. This was measured on a 7-point Likert scale, ranging from 1 ("totally disagree") to 7 ("totally agree"). Higher score means a better outcome.

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • National Institute on Aging (NIA)
  • YMCA of San Francisco

Registry information

Acronym: C-BBHP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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