Use of a Mobile Brain-Body Imaging Approach to Evaluate the Effects of Rhythmic Auditory Stimulat… (NCT07659964) | Clinical Trial Compass
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Use of a Mobile Brain-Body Imaging Approach to Evaluate the Effects of Rhythmic Auditory Stimulation on Gait and Brain Function in Alzheimer's Disease
United States40 participantsStarted 2026-06-01
Plain-language summary
Alzheimer's Disease (AD) is associated with impairments in both gait and cognition, significantly increasing fall risk. Falls are a leading cause of injury-related disability in older adults, and individuals with AD experience a nearly threefold higher rate of falls compared to neurotypical older adults. There is an urgent need for fall prevention interventions tailored to the unique deficits of individuals with AD. Converging evidence suggests that interventions aiming to reduce fall risk in AD should target both gait and cognition. Rhythmic music interventions, such as Rhythmic Auditory Stimulation (RAS) can harness global brain activation and auditory-motor entrainment to facilitate high-intensity exercise to alleviate AD-related neurocognitive and gait dysfunction. This study aims to assess the neural correlates of gait dysfunction in people with AD, evaluate if baseline neurocognitive impairment is predictive of the effects of RAS, and evaluate RAS benefits for individuals with AD.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General Inclusion (both healthy and AD populations):
* Community-dwelling
* Capable of walking short community distances (approximately 10-15 minutes at a time) without assistance from another person or a device (such as a cane).
* Able to communicate with researchers
* Age 50-90 (inclusive)
Population-specific Inclusion criteria:
* Healthy -
* No diagnosis of AD
* AD population-
CERAD score of \<1.5 SD from age + education adjusted norms on delayed recall domain or one or more other cognitive domains (i.e. language, attention).
MoCA score between 20-30 MMSE score between 25-30
Exclusion Criteria:
* Presence of significant hearing impairment
* Current orthopedic, neurologic or other medical condition that limits the ability to walk.
The MOCA, MMSE and CERAD tests will be completed in-person after the participant consents into the study. If the participant is determined to be ineligible based on their performance on these tests (compared to inclusion requirements listed above), they will be informed that they are not eligible for this study and the study visit will be cancelled. They will then be withdrawn from the study; their clinical tests and study documentation will be maintained for the purposes of completeness, but will not be used for any study analyses.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional brain network connectivity
Timeframe: within session: baseline (no RAS) and RAS-assisted walking
2
Stride time variability
Timeframe: within session: baseline (no RAS) and RAS-assisted walking
3
Gait speed
Timeframe: within session: baseline (no RAS) and RAS-assisted walking