| NCT ID | NCT07602283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-06-09 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to provide mechanistic insights into how group drumming as a music-based intervention (MBI) affects pain responses and nociceptive function in individuals with Alzheimer's Disease (AD), mild dementia or mild cognitive impairment (MCI). Heart rate (HR), heart rate variability (HRV), and brain activity will be measured during communal drumming with their dyadic partners and others. Brain activity, blood pressure, cognitive abilities, blood hormone levels, and static and dynamic pain will also be measured during sessions pre and post the 8-week community drum circle. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), quantitative sensory testing (QST), behavioral, surveys, and physiological monitoring to study the impact of group drumming on pain and brain activity in AD and inter-dyad synchrony.
Eligibility Criteria
Inclusion Criteria: * Clinical Dementia Rating 0.5 - 2 * Be a person with or caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting \>3 months that occurs most days and limits life or work activities OR Be a caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting \>3 months that occurs most days and limits life or work activities * Able to provide informed consent * Willing to wear an EEG headset and heart rate monitoring devices * Willing to answer survey questions about topics related to the study * Willing to be audio / video recorded * Willing to undergo QST, blood draw, heart rate data collection and cognitive testing Exclusion Criteria: * Clinical Dementia Rating \<0.5 or \> 2 * Unable to provide informed consent * Endorsing suicidal ideation (SI), self-injurious behavior, or homicidal ideation (HI) above the threshold defined in the "Risk Reduction and Safety Plan" * Participating in another clinical trial studying AD and/or Dementia * Starting a new prescription medication in the last 4 weeks * Taking central nervous system acting medications that may interfere with study measurements as determined at PI discretion
Contact & Investigator
AZA Allsop, MD, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07602283 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07602283 currently recruiting?
Yes, NCT07602283 is actively recruiting participants. Contact the research team at Aza.allsop@yale.edu for enrollment information.
Where is the NCT07602283 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07602283 clinical trial?
NCT07602283 is sponsored by Yale University. The principal investigator is AZA Allsop, MD, PhD at Yale University. The trial plans to enroll 60 participants.
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