Mild Cognitive ImpairmentNCT05818423
Brain Health Together: A Live-Streaming Group-Based Digital Program
A study testing Brain Health Academy, Brain Health Together and Maintain Brain Health Together in people with Mild Cognitive Impairment and Cognitive Decline, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Decline, Cognitive Deterioration
- What is being tested?
- Brain Health Academy, Brain Health Together and Maintain Brain Health Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English language fluency;*
- live in U.S.;
- cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months)
- ready to make lifestyle changes to improve brain health;
- have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc)
- have a desktop or laptop computer or iPad/tablet with a video camera;
- have broadband internet access;
- able to participate in online, live-streaming classes with two-way video
Who cannot join
- Candidates meeting any of the exclusion criteria will not be eligible to participate.
- Alzheimer's disease or dementia
- Major neurological disorder (e.g., Parkinson's disease, Multiple Sclerosis, amyotrophic Lateral Sclerosis)
- Schizophrenia or other psychotic disorder
- Autism or autism spectrum disorder
- Major mood or anxiety disorder that is not well-controlled (e.g., symptoms of depression or anxiety that made it hard to do daily tasks in past 6 months)
Show all 15Show fewer
- Fracture of spine ("compression fracture") in the past 12 months
- Vertigo or severe dizziness in the past 12 months
- Severe vision or hearing impairment (e.g., unable to see and hear well enough to watch a movie on TV);
- Stroke or heart attack in the past 12 months
- Physical limitation that would restrict ability to participate (e.g., use wheelchair or walker to get around home, unable to stand up from sitting without assistance)
- Currently in another research study that could confound results of this study (e.g., drug study or other study to improve brain health)
- Previous participation in Moving Together or Brain Health Together
- Limited life expectancy (e.g., enrolled in hospice, undergoing cancer treatment)
- If participants are not sure about certain conditions, they will be asked to describe their condition, and the research team will determine whether they meet eligibility criteria or not.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
Read the detailed description
Older adults with cognitive decline (including either mild cognitive impairment [MCI] or subjective cognitive decline [SCD]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.
- Conditions
- Mild Cognitive Impairment, Cognitive Decline, Cognitive Deterioration, Cognitive Deficits, Mild, Cognitive Impairment, Mild
- Being tested
- Brain Health Academy, Brain Health Together, Maintain Brain Health Together
- Keywords
- Memory, Cognitive
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health AcademyBehavioural
The Brain Health Academy group will review online content about brain health (1 hour, 2 days/week for 12 weeks) and will complete a brief survey after each module to assess compliance (30 hours total).
Brain Health TogetherBehavioural
The Brain Health Together group will participate in online, live-streaming, group-based Moving Together classes (1 hour/week); Brain Health education group classes (1 hour/week) and individual brain health coaching sessions (0.5 hours/week) for 12 weeks (30 hours total).
Maintain Brain Health TogetherBehavioural
The Maintaining Brain Health Together group will participate in the full Brain Health Together program (30 hours) for 12 weeks followed by weekly group classes and six individual coaching for an additional 12 weeks (additional 15 hours).
| Study group | Role | What they receive |
|---|---|---|
| Brain Health Academy | Experimental | Participants in this arm will watch expert videos on a wide range of brain health topics and will complete quizzes for 2.5 hours a week for 12 weeks (30 hours total) Receives: Behavioral: Brain Health Academy |
| Brain Health Together | Experimental | Participants in this arm will participate in online, live-streaming Moving Together classes (1 hour a week) and group brain health classes (1 hour a week) and will work 1-on-1 with a brain health coach to set personalized risk reduction goals (0.5 hours a week) for 12 weeks (30 hours total) Receives: Behavioral: Brain Health Together |
| Brain Health Together Plus | Experimental | Participants in this arm will participate in the full Brain Health Together program for 12 weeks (30 hours) followed by weekly group classes and six 1-on-1 coaching sessions for another 12 weeks (additional 15 hours; 45 hours total) Receives: Behavioral: Maintain Brain Health Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creyos Cognitive Composite - 3 Month
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Measured: Baseline to 3 months
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Measured: Baseline to 3 months
Creyos Cognitive Composite - 6 Month Change
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Measured: Baseline to 6 months
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Measured: Baseline to 6 months
Secondary outcomes (22)
Loneliness / Social Isolation - 3 Month Change
Loneliness / social isolation was measured using the validated 3-item UCLA Loneliness Scale, which consists of 3 items (lack companionship, feel left out, feel isolated) that are rated as 1 (hardly ever), 2 (some of the time), or 3 (often). Scores may range from 3 to 9, with higher scores reflecting greater loneliness. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
Measured: Baseline to 3 months
Depression - 3 Month Change
We assessed depressive symptoms using the validated 10-item version of the Center for Epidemiologic Studies-Depression Scale (CES-D). Participants are asked about feelings in the past week with response categories of 0 (<1/day), 1 (1-2 days), 2 (3-4 days) or 3 (5-7 days). Scores may range from 0 to 30, with higher scores indicating more depressive symptoms. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
Measured: Baseline to 3 months
Cognitive Activity - 3 Month Change
We measured engagement in cognitive stimulating activities using the validated Cognitive Activity Questionnaire (CAQ). The CAQ includes 11 items that ask how often individuals engage in various cognitive activities such as reading or playing games on a 6-point Likert scale (once a month/never to every day). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
Measured: Baseline and 3 months
Physical Activity - 3 Month Change
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were asked about time spent (days/week, minutes/day) doing vigorous physical activity, moderate physical activity, walking and sitting in the past 7 days, and responses were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
Measured: Baseline to 3 months
Emotional Well-being - 3 Month Change
We assessed emotional well-being using the Neuro-QOL v1.0 Positive Affect and Well-Being Short Form, which includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores may range from 9 to 45, with higher scores reflecting greater feelings of well-being. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
Measured: Baseline to 3 months
Self-regulation - 3 Month Change
We measured mind-body awareness using the self-regulation sub-scale of the validated Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). The self-regulation sub-scale includes 4 items rated on a six-point Likert scale (0/never to 5/always) about the ability to regulate distress by paying attention to bodily sensations (e.g., "When I feel overwhelmed I can find a calm place inside.") Scores reflect the mean of responses (range 0 to 5), with higher scores indicating greater self-regulation. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
Measured: Baseline to 3 months
Diet - 3 Month Change
We measured diet using the validated MIND diet score. The MIND diet is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets. It has 15 dietary components including 10 brain healthy foods (e.g., green leafy vegetables, berries) and 5 less healthy foods (e.g., red meat, fried/fast foods). The frequency of consumption for each item is scored as 0, 0.5 or 1, and the total MIND diet score is calculated by summing over the 15 components. Scores may range from 0 to 15, with higher scores reflecting better adherence to the MIND diet. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
Measured: Baseline and 3 months
Sleep Disturbance - 3 Month Change
We measured sleep disturbance using the validated PROMIS Sleep Disturbance Short Form 4-item measure, which asks about sleep quality and disturbance in the past 7 days on a 5-point Likert scale. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
Measured: Baseline to 3 months
Self-efficacy/Confidence 3 Month Change
We used a modified version of the Self-Efficacy for Managing Chronic Disease 6-item scale to measure self-efficacy for engaging in activities to support brain health. Each item is rated on an 11-point Likert scale from 0 (not at all confident) to 10 (totally confident). The score is the mean of the 6 items with higher scores reflecting higher self-efficacy. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
Measured: Baseline to 3 months
Global Quality of Life - Physical - 3 Month Change
We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Measured: Baseline to 3 months
Global Quality of Life - Mental - 3 Month Change
We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Measured: Baseline to 3 months
Loneliness / Social Isolation - 6 Month Change
Loneliness / social isolation was measured using the validated 3-item UCLA Loneliness Scale, which consists of 3 items (lack companionship, feel left out, feel isolated) that are rated as 1 (hardly ever), 2 (some of the time), or 3 (often). Scores may range from 3 to 9, with higher scores reflecting greater loneliness. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
Measured: Baseline to 6 months
Depression - 6 Month Change
We assessed depressive symptoms using the validated 10-item version of the Center for Epidemiologic Studies-Depression Scale (CES-D). Participants are asked about feelings in the past week with response categories of 0 (<1/day), 1 (1-2 days), 2 (3-4 days) or 3 (5-7 days). Scores may range from 0 to 30, with higher scores indicating more depressive symptoms. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
Measured: baseline to 6 months
Cognitive Activity - 6 Month Change
We measured engagement in cognitive stimulating activities using the validated Cognitive Activity Questionnaire (CAQ). The CAQ includes 11 items that ask how often individuals engage in various cognitive activities such as reading or playing games on a 6-point Likert scale (once a month/never to every day). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
Measured: Baseline to 6 months
Physical Activity - 6 Month Change
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were asked about time spent (days/week, minutes/day) doing vigorous physical activity, moderate physical activity, walking and sitting in the past 7 days, and responses were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
Measured: Baseline to 6 months
Emotional Well-being - 6 Month Change
We assessed emotional well-being using the Neuro-QOL v1.0 Positive Affect and Well-Being Short Form, which includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores may range from 9 to 45, with higher scores reflecting greater feelings of well-being. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
Measured: 0 to 6 months
Self-Regulation - 6 Month Change
We measured mind-body awareness using the self-regulation sub-scale of the validated Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). The self-regulation sub-scale includes 4 items rated on a six-point Likert scale (0/never to 5/always) about the ability to regulate distress by paying attention to bodily sensations (e.g., "When I feel overwhelmed I can find a calm place inside.") Scores reflect the mean of responses (range 0 to 5), with higher scores indicating greater self-regulation. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
Measured: 0 to 6 months
Diet - 6 Month Change
We measured diet using the validated MIND diet score. The MIND diet is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets. It has 15 dietary components including 10 brain healthy foods (e.g., green leafy vegetables, berries) and 5 less healthy foods (e.g., red meat, fried/fast foods). The frequency of consumption for each item is scored as 0, 0.5 or 1, and the total MIND diet score is calculated by summing over the 15 components. Scores may range from 0 to 15, with higher scores reflecting better adherence to the MIND diet. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
Measured: 0 to 6 months
Sleep Disturbance - 6 Month Change
We measured sleep disturbance using the validated PROMIS Sleep Disturbance Short Form 4-item measure, which asks about sleep quality and disturbance in the past 7 days on a 5-point Likert scale. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
Measured: 0 to 6 months
Self-efficacy/Confidence - 6 Month Change
We used a modified version of the Self-Efficacy for Managing Chronic Disease 6-item scale to measure self-efficacy for engaging in activities to support brain health. Each item is rated on an 11-point Likert scale from 0 (not at all confident) to 10 (totally confident). The score is the mean of the 6 items with higher scores reflecting higher self-efficacy. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
Measured: 0 to 6 months
Global Quality of Life - Physical - 6 Month Change
We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Measured: 0 to 6 months
Global Quality of Life - Mental - 6 Month Change
We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start10 Apr 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Deborah Barnes, PhD, Principal investigator, Primary Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818423
- Sponsor's protocol ID
- 21-35002
- Other IDs
- R44AG074727
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2023
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Health Together: A Live-Streaming Group-Based Digital Program
- ClinicalTrials.gov ID
- NCT05818423
- Acronym / sponsor ID
- 21-35002
- Conditions
- Mild Cognitive Impairment, Cognitive Decline, Cognitive Deterioration, Cognitive Deficits, Mild, Cognitive Impairment, Mild
- Keywords
- Memory, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
Detailed description
Older adults with cognitive decline (including either mild cognitive impairment [MCI] or subjective cognitive decline [SCD]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain Health Academy | Experimental | Behavioral: Brain Health AcademyParticipants in this arm will watch expert videos on a wide range of brain health topics and will complete quizzes for 2.5 hours a week for 12 weeks (30 hours total) |
| Brain Health Together | Experimental | Behavioral: Brain Health TogetherParticipants in this arm will participate in online, live-streaming Moving Together classes (1 hour a week) and group brain health classes (1 hour a week) and will work 1-on-1 with a brain health coach to set personalized risk reduction goals (0.5 hours a week) for 12 weeks (30 hours total) |
| Brain Health Together Plus | Experimental | Behavioral: Maintain Brain Health TogetherParticipants in this arm will participate in the full Brain Health Together program for 12 weeks (30 hours) followed by weekly group classes and six 1-on-1 coaching sessions for another 12 weeks (additional 15 hours; 45 hours total) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English language fluency;*
- live in U.S.;
- cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months)
- ready to make lifestyle changes to improve brain health;
- have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc)
Key exclusion criteria (15 listed)
- Candidates meeting any of the exclusion criteria will not be eligible to participate.
- Alzheimer's disease or dementia
- Major neurological disorder (e.g., Parkinson's disease, Multiple Sclerosis, amyotrophic Lateral Sclerosis)
- Schizophrenia or other psychotic disorder
- Autism or autism spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Health AcademyThe Brain Health Academy group will review online content about brain health (1 hour, 2 days/week for 12 weeks) and will complete a brief survey after each module to assess compliance (30 hours total). | Behavioural | Brain Health Academy |
| Brain Health TogetherThe Brain Health Together group will participate in online, live-streaming, group-based Moving Together classes (1 hour/week); Brain Health education group classes (1 hour/week) and individual brain health coaching sessions (0.5 hours/week) for 12 weeks (30 hours total). | Behavioural | Brain Health Together |
| Maintain Brain Health TogetherThe Maintaining Brain Health Together group will participate in the full Brain Health Together program (30 hours) for 12 weeks followed by weekly group classes and six individual coaching for an additional 12 weeks (additional 15 hours). | Behavioural | Brain Health Together Plus |
Primary outcome
Creyos Cognitive Composite - 3 Month
Time frame: Baseline to 3 months
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change
Time frame: Baseline to 3 months
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Creyos Cognitive Composite - 6 Month Change
Time frame: Baseline to 6 months
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change
Time frame: Baseline to 6 months
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
22 secondary outcomes
Loneliness / Social Isolation - 3 Month Change
Time frame: Baseline to 3 months
Depression - 3 Month Change
Time frame: Baseline to 3 months
Cognitive Activity - 3 Month Change
Time frame: Baseline and 3 months
Physical Activity - 3 Month Change
Time frame: Baseline to 3 months
Emotional Well-being - 3 Month Change
Time frame: Baseline to 3 months
Self-regulation - 3 Month Change
Time frame: Baseline to 3 months
Diet - 3 Month Change
Time frame: Baseline and 3 months
Sleep Disturbance - 3 Month Change
Time frame: Baseline to 3 months
Self-efficacy/Confidence 3 Month Change
Time frame: Baseline to 3 months
Global Quality of Life - Physical - 3 Month Change
Time frame: Baseline to 3 months
Global Quality of Life - Mental - 3 Month Change
Time frame: Baseline to 3 months
Loneliness / Social Isolation - 6 Month Change
Time frame: Baseline to 6 months
Depression - 6 Month Change
Time frame: baseline to 6 months
Cognitive Activity - 6 Month Change
Time frame: Baseline to 6 months
Physical Activity - 6 Month Change
Time frame: Baseline to 6 months
Emotional Well-being - 6 Month Change
Time frame: 0 to 6 months
Self-Regulation - 6 Month Change
Time frame: 0 to 6 months
Diet - 6 Month Change
Time frame: 0 to 6 months
Sleep Disturbance - 6 Month Change
Time frame: 0 to 6 months
Self-efficacy/Confidence - 6 Month Change
Time frame: 0 to 6 months
Global Quality of Life - Physical - 6 Month Change
Time frame: 0 to 6 months
Global Quality of Life - Mental - 6 Month Change
Time frame: 0 to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Barnes, PhD principal investigator
Primary Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Health Academy, Brain Health Together and Maintain Brain Health Together in people with Mild Cognitive Impairment and Cognitive Decline, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creyos Cognitive Composite - 3 Month (time frame: Baseline to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.