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Community-based Brain Health Program to Address Dementia Risk (C-BBHP)

Primary Purpose

Dementia, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Health Program
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants who are 65 years of age or older.
  2. Participants who meet criteria for two or more Alzheimer's Disease and related 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
    7. OR, meet criteria for elevated risk factors, as determined via the Australian National University AD Risk Index (ANU-ADRI) assessment instrument, a questionnaire-based measure that assess fixed and modifiable risk factors for dementia. The ANU-ADRI has been used in multi-modal studies of behavioral change interventions to reduce dementia risk, and scores have been shown to predict the transition from healthy aging to mild cognitive impairment (MCI) - a crucial measure of dementia risk.
  3. Participants who are fluent English speakers from the age of 12, per self-report, to ensure reasonable neuropsychological results on key assessments.
  4. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.

Exclusion Criteria:

  1. Participants who are not able to provide informed consent
  2. Participants who ≤ 25 on the Cognitive Abilities Screening Instrument (CASI), suggestive of cognitive impairment, or ≥ 30, low likelihood of experiencing cognitive decline over 2 years
  3. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, recent hospitalization, ongoing chemotherapy or other cancer treatment
  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 using computer-based cognitive training programs or has used it within a month of the consent date
  6. Potential participants answers 'yes' to: Question 4 (Active Suicidal Ideation with Intent) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" if the ideation or behavior occurred within 2 months from Participant's date of consent.

Sites / Locations

  • YMCA of San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain Health Program

Arm Description

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

Outcomes

Primary Outcome Measures

Net Promoter Score
The scoring for this answer is based on a 0 to 10 scale. Those who respond with a score of 9 to 10 are called Promoters, and are considered likely to exhibit value-creating behaviors, such as making more positive referrals to other potential program participants. Those who respond with a score of 0 to 6 are labeled Detractors, and they are believed to be less likely to exhibit the value-creating behaviors. Responses of 7 and 8 are labeled Passives, and their behavior falls between Promoters and Detractors. The Net Promoter Score is calculated by subtracting the percentage of customers who are Detractors from the percentage of customers who are Promoters. For purposes of calculating a Net Promoter Score, Passives count toward the total number of respondents, thus decreasing the percentage of detractors and promoters and pushing the net score toward 0.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2022
Last Updated
May 2, 2023
Sponsor
Posit Science Corporation
Collaborators
YMCA of San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05529706
Brief Title
Community-based Brain Health Program to Address Dementia Risk
Acronym
C-BBHP
Official Title
Community-based Brain Health Program to Address Dementia Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
YMCA of San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain Health Program
Arm Type
Experimental
Arm Description
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program.
Intervention Type
Other
Intervention Name(s)
Brain Health Program
Intervention Description
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 Outcome Measure Information:
Title
Net Promoter Score
Description
The scoring for this answer is based on a 0 to 10 scale. Those who respond with a score of 9 to 10 are called Promoters, and are considered likely to exhibit value-creating behaviors, such as making more positive referrals to other potential program participants. Those who respond with a score of 0 to 6 are labeled Detractors, and they are believed to be less likely to exhibit the value-creating behaviors. Responses of 7 and 8 are labeled Passives, and their behavior falls between Promoters and Detractors. The Net Promoter Score is calculated by subtracting the percentage of customers who are Detractors from the percentage of customers who are Promoters. For purposes of calculating a Net Promoter Score, Passives count toward the total number of respondents, thus decreasing the percentage of detractors and promoters and pushing the net score toward 0.
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah-Jane Grant
Phone
415-539-3130
Email
sarah-jane.grant@positscience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Vleet, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
YMCA of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah-Jane Grant
Email
sarah-jane.grant@positscience.com

12. IPD Sharing Statement

Learn more about this trial

Community-based Brain Health Program to Address Dementia Risk

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