Trial Outcomes & Findings for Community-based Brain Health Program to Address Dementia Risk (NCT NCT05529706)

NCT ID: NCT05529706

Last Updated: 2026-07-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

At 12 weeks

Results posted on

2026-07-27

Participant Flow

12 participants did not meet study criteria and 3 participants withdrew consent before group assignment.

Participant milestones

Participant milestones
Measure
Brain Health Program
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Overall Study
STARTED
71
Overall Study
COMPLETED
66
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Brain Health Program
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Overall Study
Withdrawal by Subject
3
Overall Study
Withdrawn by Investigator
2

Baseline Characteristics

Community-based Brain Health Program to Address Dementia Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Brain Health Program
n=71 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Age, Continuous
74.5 years
STANDARD_DEVIATION 5.8 • n=9 Participants
Sex: Female, Male
Female
59 Participants
n=9 Participants
Sex: Female, Male
Male
12 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
53 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
17 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
Race (NIH/OMB)
White
41 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=9 Participants
Years of Education
16 years
STANDARD_DEVIATION 3.5 • n=9 Participants
Cognitive Abilities Screening Instrument-Short (CASI-Short)
31.2 units on a scale
STANDARD_DEVIATION 2.1 • n=9 Participants

PRIMARY outcome

Timeframe: At 12 weeks

Population: While 71 started the intervention, 3 withdrew consent and 2 were withdrawn by investigator during the intervention so a total of 66 participants completed the study.

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Net Promoter Score
65 score on a scale
Interval 51.0 to 79.0

SECONDARY outcome

Timeframe: At 12 weeks

Outcome measures

Outcome measures
Measure
Brain Health Program
n=71 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Percentage of Participants Who Complete at 80% of Intended Program Sessions.
66 Participants

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Program Comprehension
6.5 score on a scale
Standard Deviation 0.64

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Relevancy of Program
6.2 score on a scale
Standard Deviation 0.77

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Program Awareness
7.0 score on a scale
Standard Deviation 0.71

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Program Work Assignments
6.8 score on a scale
Standard Deviation 0.77

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Positive Lifestyle Change Post-program
6.8 score on a scale
Standard Deviation 0.76

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Outcome measures
Measure
Brain Health Program
n=66 Participants
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Program Satisfaction
6.1 score on a scale
Standard Deviation 0.89

Adverse Events

Brain Health Program

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Brain Health Program
n=71 participants at risk
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program. 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).
Musculoskeletal and connective tissue disorders
Fall
1.4%
1/71 • Number of events 1 • Adverse event data are collected throughout the study duration. Study participation is 12 weeks.
Adverse events are assessed at each assessment visit (at Baseline and Post-Intervention visits) and throughout the intervention period.
Eye disorders
Eye Strain
1.4%
1/71 • Number of events 1 • Adverse event data are collected throughout the study duration. Study participation is 12 weeks.
Adverse events are assessed at each assessment visit (at Baseline and Post-Intervention visits) and throughout the intervention period.

Additional Information

Dr. Tom Van Vleet

Posit Science Corporation

Phone: (415) 394-3100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place