Alzheimer Disease (AD)NCT07659964
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
A study testing Metronome in people with Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- Metronome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Dec 2026
- Phase
- Interventional
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, 02215
Louis N Awad, PT, DPT, PhD, 617-500-3645, gaitlab@bu.edu
About this study
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.
Read the detailed description
- 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.
- Study Design and Overview: This is a single-session, non-randomized clinical trial enrolling 40 subjects -- 20 adults with a clinical diagnosis of AD (restricted to mild cognitive impairment, MCI) and 20 neurotypical older adults serving as a healthy comparison group. All participants complete one study visit conducted at the Boston University (BU) Neuromotor Recovery Laboratory (NRL) and/or affiliated BU clinical research facilities.
- Specific Aims The study pursues three primary aims:
- To characterize the neural correlates of gait dysfunction in people with AD using simultaneous brain-body imaging during walking under typical and challenging conditions.
- To evaluate whether baseline neurocognitive profile (degree and domain of impairment) predicts individual responsiveness to RAS during walking.
- To quantify the acute effects of RAS on gait and functional brain connectivity in individuals with AD compared to neurotypical older adults.
- Measurement Framework \& Outcome Measures: Mobile Brain-Body Imaging (MoBI): A defining feature of this study is the use of a Mobile Brain-Body Imaging (MoBI) framework consisting of the concurrent capture of neural and biomechanical data during real-time ambulation. Brain activity is measured using functional near-infrared spectroscopy (fNIRS), a non-invasive optical neuroimaging technique that quantifies changes in cortical hemodynamics (oxy- and deoxy-hemoglobin concentration) as a proxy for regional neural activation. Unlike traditional neuroimaging modalities, fNIRS is tolerant of movement artifact, making it well-suited for ambulatory paradigms. Biomechanical gait data are collected concurrently using inertial measurement units (IMUs).
- Walking Conditions: Participants will walk overground under multiple conditions designed to vary cognitive and sensorimotor demand: a) walking with and without RAS and b) walking on an altered, gait-destablizing surface (foam mat or rocker-bottom footwear) to increase sensorimotor challenge. These conditions are intended to elicit a gradient of gait and neural responses and to probe the extent to which RAS can attenuate dual-task interference and cognitive-motor coupling deficits characteristic of AD.
- Cognitive Assessment: A standardized neuropsychological battery will be administered to all participants with AD to characterize baseline cognitive status and confirm MCI diagnosis. This battery includes the Montreal Cognitive Assessment (MoCA), Mini Mental Status Examination (MMSE), Consortium to Establish a Registry in Alzheimer's Disease (CERAD) delayed recall, Boston Naming Test (short form), Trail Making Test A and B, and verbal fluency measures. These assessments will be used to examine relationships between neurocognitive impairment profile and the magnitude of RAS benefit observed during walking.
- Significance: This study will generate foundational data linking neural mechanisms of gait dysfunction in AD with behavioral responsiveness to an accessible, non-pharmacological auditory-motor intervention in a population at high fall risk and with limited therapeutic options. Findings are intended to inform participant selection criteria and outcome measure development for future RAS-based clinical trials targeting fall prevention in AD.
- Being tested
- Metronome
- Keywords
- RAS
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronomeOther
Rhythmic Auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| Effects of RAS on gait quality on brain activity in individuals with and without AD | Experimental | 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). Receives: Other: Metronome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain network connectivity
Functional connectivity between the Dorsal Attention Network and Default Mode Network measured using fNIRS during walking.
Measured: within session: baseline (no RAS) and RAS-assisted walking
Stride time variability
Variability in stride timing measured using inertial measurement units during walking.
Measured: within session: baseline (no RAS) and RAS-assisted walking
Gait speed
Average walking speed measured in meters per second during overground walking.
Measured: within session: baseline (no RAS) and RAS-assisted walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Louis N Awad, PT, DPT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659964
- Sponsor's protocol ID
- 8203
- Other IDs
- 5U24AG084436-02
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Lo OY, Halko MA, Devaney KJ, Wayne PM, Lipsitz LA, Manor B. Gait Variability Is Associated With the Strength of Functional Connectivity Between the Default and Dorsal Attention Brain Networks: Evidence From Multiple Cohorts. J Gerontol A Biol Sci Med Sci. 2021 Sep 13;76(10):e328-e334. doi: 10.1093/gerona/glab200.
PubMed 34244725