An interventional study of Metronome in Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), sponsored by Boston University Charles River Campus. Recruiting at 1 site in United States. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment
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.
Background and Scientific Rationale: Alzheimer's Disease (AD) is a progressive neurodegenerative disorder characterized by the accumulation of amyloid-beta plaques and tau neurofibrillary tangles, leading to widespread cortical and subcortical atrophy. While memory impairment is the most recognized clinical feature, AD also profoundly disrupts motor systems - particularly gait - through degeneration of frontal-subcortical circuits that govern attentional control of movement. Gait deficits in AD include reduced speed, shortened stride length, increased stride variability, and disproportionate cognitive-motor interference during dual-task conditions. These impairments reflect underlying disruptions in prefrontal-motor connectivity and are strongly predictive of fall events.
Rhythmic Auditory Stimulation (RAS) is an interventional technique that harnesses the coupling between the auditory and motor systems. Rhythmic auditory cues delivered as an isochronous beat (with or without music) activate auditory-motor entrainment pathways, recruiting motor planning circuits in the basal ganglia, supplementary motor area, and cerebellum to promote more stable and efficient gait. RAS has demonstrated efficacy in improving gait parameters in neurological populations including Parkinson's disease and stroke. Its application in AD is motivated by evidence that music-based rhythmic stimuli elicit broad, cross-regional brain activation, including areas relatively spared in early AD, and may therefore provide a viable sensory scaffold for augmenting motor control even as cognitive reserve declines.
Specific Aims
The study pursues three primary aims:
General Inclusion (both healthy and AD populations):
Population-specific Inclusion criteria:
Healthy -
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:
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.
Participants will complete overground walking assessments with and without rhythmic auditory stimulation (RAS) under varying sensorimotor conditions while gait and cortical activity are measured using wearable sensors (IMUs) and portable neuroimaging (fNIRS).
Other: Metronome
Rhythmic Auditory stimulation
Functional brain network connectivity
Functional connectivity between the Dorsal Attention Network and Default Mode Network measured using fNIRS during walking.
Time frame: within session: baseline (no RAS) and RAS-assisted walking
Stride time variability
Variability in stride timing measured using inertial measurement units during walking.
Time frame: within session: baseline (no RAS) and RAS-assisted walking
Gait speed
Average walking speed measured in meters per second during overground walking.
Time frame: within session: baseline (no RAS) and RAS-assisted walking
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications arising from this study will be made available. Shared data may include participant demographics, clinical characteristics, gait and biomechanical measures, neurophysiological measures, metronome settings for delivery of RAS, and other study variables necessary to reproduce published findings. Data will be de-identified prior to sharing in accordance with applicable regulations and institutional policies.
Supporting information: Study protocol, Icf, Analytic code
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Boston University Charles River Campus