Community-based Brain Health Program to Address Dementia Risk

NCT ID: NCT05529706

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2024-10-18

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brain Health Program

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

Group Type: EXPERIMENTAL

Brain Health Program

Intervention Type: 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).

Interventions

Brain 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).

Intervention Type: OTHER

Eligibility Criteria

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

1. Inability to provide informed consent

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 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.

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YMCA of San Francisco

UNKNOWN

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Van Vleet, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

YMCA of San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

PSC-0318-22

Identifier Type: -

Identifier Source: org_study_id