ClinicalTrials.gg
CompletedNCT05529706C-BBHPUpdated Jul 27, 2026Results posted

Community-based Brain Health Program to Address Dementia Risk

An interventional study of Brain Health Program in Dementia and Alzheimer Disease, sponsored by Posit Science Corporation. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Primary conditionAlzheimer DiseaseRegistry: DementiaReclassifiedWhy we changed it
Registry
Dementia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Alzheimer Disease
Why
  1. The study's listed conditions name Alzheimer Disease, a narrower term within Dementia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,937 studies in Alzheimer Disease with a site in United States — 343 open to participants now, 444 under way, 39 of them phase 3. Alzheimer Disease · United States.

Enrollment
726th of 1,606
86 · median 73
Started
2023
with 114 others
No phase
607 of 1,937
129 open now
Registered
1,502nd of 1,937
by date

Among the 1,937 studies in Alzheimer Disease with a site in United States, this one is the 726th largest by enrollment of the 1,606 interventional ones that give a count, is one of 115 that started in 2023, is one of 607 with no phase, and was the 1,502nd registered.

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

343 of the 1,937 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:

338 more — sign in →

All 343 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,937 studies in Alzheimer Disease with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Dementia
  • Alzheimer Disease

Browse trials for

04

In context

Alzheimer Disease Reclassified

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 86 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants who are 65 years of age or older.
  2. Participants who meet criteria for one or more ADRD dementia risk factors

    1. Family history of Alzheimer's dementia (1st degree relative)
    2. Genetic marker (APOE4++)
    3. 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?"
    4. Poorly controlled hypertension or diabetes
    5. Physical inactivity \<150min/week per Surgeon General guidelines
    6. Social isolation, in which participant rarely or never gets social and emotional support when needed
  3. Participants who are fluent English or Spanish speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
  4. Participants have access to an internet accessible device (eg. laptop, desktop computer, tablet or smartphone)
  5. Participants are able to attend all 12 classes (once a week for 12 weeks) and make up missed classes, as needed
  6. Participants are able to travel to/from YMCA location, if they choose to be a part of the in-person group

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide
  2. Cognitive Abilities Screening Instrument - Short (CASI-Short) scores ≤ 25 (suggestive of cognitive impairment)
  3. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders.
  4. Participants enrolled in a concurrent clinical trial involving an 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.
  5. Participants presently attending classes or courses like this program that is focused on dementia risk and behavior management.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Brain Health Program

    A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program.

    Other: Brain Health Program

Interventions

  • OtherBrain Health Program

    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).

07

What researchers measure

Primary outcomes

  1. Net Promoter Score

    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.

    Time frame: At 12 weeks

Secondary outcomes

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

    Time frame: At 12 weeks

  2. Program Comprehension

    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.

    Time frame: At 12 weeks

  3. Relevancy of Program

    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.

    Time frame: At 12 weeks

  4. Program Awareness

    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.

    Time frame: At 12 weeks

  5. Program Work Assignments

    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.

    Time frame: At 12 weeks

  6. Positive Lifestyle Change Post-program

    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.

    Time frame: At 12 weeks

  7. Program Satisfaction

    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.

    Time frame: At 12 weeks

08

Results

Posted Jul 27, 2026

Participant flow

Participant flow — Overall Study
MilestoneBrain Health Program
Started71
Completed66
Not completed5
Withdrew: Withdrawal by subject3
Withdrew: Withdrawn by investigator2

Outcome measures

PrimaryNet Promoter Score

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.

Time frame:
At 12 weeks
Reported as:
Number · score on a scale
Net Promoter Score
score on a scaleBrain Health Program
Net Promoter Score65 (51 to 79)
SecondaryPercentage of Participants Who Complete at 80% of Intended Program Sessions.
Time frame:
At 12 weeks
Reported as:
Count of participants · Participants
Percentage of Participants Who Complete at 80% of Intended Program Sessions.
ParticipantsBrain Health Program
Percentage of Participants Who Complete at 80% of Intended Program Sessions.66
SecondaryProgram Comprehension

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Program Comprehension
score on a scaleBrain Health Program
Program Comprehension6.5 ± 0.64
SecondaryRelevancy of Program

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Relevancy of Program
score on a scaleBrain Health Program
Relevancy of Program6.2 ± 0.77
SecondaryProgram Awareness

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Program Awareness
score on a scaleBrain Health Program
Program Awareness7.0 ± 0.71
SecondaryProgram Work Assignments

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Program Work Assignments
score on a scaleBrain Health Program
Program Work Assignments6.8 ± 0.77
SecondaryPositive Lifestyle Change Post-program

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Positive Lifestyle Change Post-program
score on a scaleBrain Health Program
Positive Lifestyle Change Post-program6.8 ± 0.76
SecondaryProgram Satisfaction

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.

Time frame:
At 12 weeks
Reported as:
Mean · score on a scale
Program Satisfaction
score on a scaleBrain Health Program
Program Satisfaction6.1 ± 0.89

Adverse events

Collected over Adverse event data are collected throughout the study duration. Study participation is 12 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Brain Health Program0/71 (0%)0/71 (0%)2/71 (2.8%)
Most frequent other events
Most frequent other events
EventBrain Health Program
FallMusculoskeletal and connective tissue disorders1/71
Eye StrainEye disorders1/71

Baseline characteristics

Age, Continuous
Age, Continuous(years)Brain Health Program
Mean74.5 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)Brain Health Program
Female59
Male12
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Brain Health Program
Hispanic or Latino17
Not Hispanic or Latino53
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Brain Health Program
American Indian or Alaska Native0
Asian17
Native Hawaiian or Other Pacific Islander0
Black or African American0
White41
More than one race2
Unknown or Not Reported11
Years of Education
Years of Education(years)Brain Health Program
Mean16 ± 3.5
Cognitive Abilities Screening Instrument-Short (CASI-Short)
Cognitive Abilities Screening Instrument-Short (CASI-Short)(units on a scale)Brain Health Program
Mean31.2 ± 2.1
09

Study locations

1 site
  • YMCA of San Francisco
    San Francisco, California 94105, United States
10

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Oct 2024, 17 months.

Results were first posted in Jul 2026, 1 year 9 months after primary completion.

Of 77 industry-sponsored interventional studies with no phase under Alzheimer Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 17 months is below that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2022
First posted
Sep 7, 2022
StartActual
Apr 24, 2023
Primary completionActual
Oct 18, 2024
CompletionActual
Oct 18, 2024
Results first posted
Jul 27, 2026
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT05529706
Collaborators
YMCA of San Francisco, National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
Apr 24, 2023
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024
Results posted
Jul 27, 2026
Last update
Jul 27, 2026

Study contacts

Thomas Van Vleet, PhD
principal investigator · Posit Science Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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