Community-based Brain Health Program to Address Dementia Risk

NCT05529706 | Completed Results

• 2 other identifiers: PSC-0318-221R43AG074756
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Alzheimer Disease

Outcome Measures

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.

  At 12 weeks

Secondary Outcomes (7)

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

  At 12 weeks

• Program Comprehension

  At 12 weeks

• Relevancy of Program

  At 12 weeks

• Program Awareness

  At 12 weeks

• Program Work Assignments

  At 12 weeks

Study Arms (1)

Brain Health Program

EXPERIMENTAL

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

Other: Brain Health Program

Interventions

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).

Brain Health Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• YMCA of San Francisco: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

YMCA of San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Tom Van Vleet
• Organization: Posit Science Corporation

tom.vanvleet@positscience.com

(415) 394-3100

Study Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: April 24, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: July 27, 2026
• Results First Posted: July 27, 2026

Record last verified: 2026-07

Locations

US (1)