Alzheimer Disease, Dementia
Conditions
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.
Interventions
OTHERBrain 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).
Sponsors
Posit Science Corporation
YMCA of San Francisco
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Promoter Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complete at 80% of Intended Program Sessions. | At 12 weeks | — |
| Program Comprehension | 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. |
| Relevancy of Program | 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. |
| Program Awareness | 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. |
| Program Work Assignments | 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. |
| Positive Lifestyle Change Post-program | 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. |
| Program Satisfaction | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Van Vleet, PhD
Posit Science Corporation
Participant flow
Pre-assignment details
12 participants did not meet study criteria and 3 participants withdrew consent before group assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74.5 years STANDARD_DEVIATION 5.8 |
| Cognitive Abilities Screening Instrument-Short (CASI-Short) | 31.2 units on a scale STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 12 Participants |
| Years of Education | 16 years STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 2 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
None listed