DementiaC-BBHPNCT05529706
Community-based Brain Health Program to Address Dementia Risk
A study testing Brain Health Program in people with Dementia and Alzheimer Disease, run by Posit Science Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Brain Health Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
YMCA of San Francisco
San Francisco, California, 94105
About this study
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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Brain Health Program
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health ProgramOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Brain Health Program | Experimental | A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. Receives: Other: Brain Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 weeks
Secondary outcomes (7)
Percentage of Participants Who Complete at 80% of Intended Program Sessions.
Measured: At 12 weeks
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.
Measured: At 12 weeks
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.
Measured: At 12 weeks
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.
Measured: At 12 weeks
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.
Measured: At 12 weeks
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.
Measured: At 12 weeks
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.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start24 Apr 2023
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- YMCA of San Francisco, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Thomas Van Vleet, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529706
- Sponsor's protocol ID
- PSC-0318-22
- Other IDs
- 1R43AG074756
- Acronym
- C-BBHP
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2022
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Brain Health Program to Address Dementia Risk
- ClinicalTrials.gov ID
- NCT05529706
- Acronym / sponsor ID
- C-BBHP / PSC-0318-22
- Conditions
- Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- YMCA of San Francisco, National Institute on Aging (NIA)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Health Program | Experimental | Other: Brain Health ProgramA multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Participants who are 65 years of age or older.
- Participants who meet criteria for one or more ADRD dementia risk factors
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Health ProgramThe 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). | Other | Brain Health Program |
Primary outcome
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.
7 secondary outcomes
Percentage of Participants Who Complete at 80% of Intended Program Sessions.
Time frame: At 12 weeks
Program Comprehension
Time frame: At 12 weeks
Relevancy of Program
Time frame: At 12 weeks
Program Awareness
Time frame: At 12 weeks
Program Work Assignments
Time frame: At 12 weeks
Positive Lifestyle Change Post-program
Time frame: At 12 weeks
Program Satisfaction
Time frame: At 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Health Program in people with Dementia and Alzheimer Disease, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Promoter Score (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.