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Brain health program shows promise in early trial for older adults

NCT ID NCT05934136

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an 8-week group program called My Healthy Brain for older adults with memory concerns and lifestyle risk factors for dementia. The program, delivered via Zoom, taught mindfulness and behavior change skills to help participants improve exercise, sleep, diet, and other habits. The main goal was to see if the program was feasible and acceptable, not to measure its effect on dementia itself.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (group lifestyle program with mindfulness and behavior change skills)
What this could lead to
If successful, this could point toward a practical, low-cost program to help older adults adopt healthier habits that may lower dementia risk.
What could go wrong
This is a small, early feasibility study with only 60 participants, so it cannot prove the program actually prevents dementia. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older * Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6 * Telephone Interview for Cognitive Status-41 ≥ 31 * Functional Assessment Questionnaire \< 9 * English fluency/literacy * Ability and willingness to participate via live video * No self-reported safety issues with initiating lifestyle changes during the study Exclusion Criteria: * Mild cognitive impairment, dementia, or neurodegenerative disease * Psychotropic medications (e.g., antidepressant) change in the last 3 months * Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia or schizoaffective disorder * Current self-report of suicidal ideation * Serious medical illness expected to worsen in 6 months (e.g., cancer) * Use of digital monitoring device (e.g., Fitbit) in the last 3 moths AND unwillingness to stop using personal digital monitoring device for duration of program * Mindfulness or mind-body practice (\> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in \< 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in \< 3 months * Average daily step count \> 5,000 steps * More than 30 minutes of exercise daily

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Conditions

The condition(s) this trial relates to.

Memory Disorders Risk Reduction Behavior subjective cognitive decline dementia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy lifestyle Memory loss (excluding dementia) Risk reduction behavior

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.