Exploring the effects of live music on early Alzheimer's patients and their caregivers
Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers
This study is testing whether live music can help people with early Alzheimer's and their caregivers feel less anxious and more connected to each other.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06940687 on ClinicalTrials.gov |
What this trial studies
This study investigates how live music impacts individuals with early Alzheimer's Disease, dementia, and mild cognitive impairment, along with their caregivers. Participants will experience live music performances while their brain activity and heart rates are monitored using EEG and heart rate variability techniques. The study aims to assess whether live music can reduce anxiety and enhance emotional connection between patients and caregivers, utilizing various measurement methods including surveys and physiological monitoring. The research will take place in music venues in the Greater New Haven area, with potential expansions to Washington, DC, and Nashville, TN.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with early Alzheimer's Disease, mild dementia, or mild cognitive impairment, along with their caregivers.
Not a fit: Patients with a Clinical Dementia Rating below 0.5 or above 2, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to improve emotional well-being and reduce anxiety in early Alzheimer's patients and their caregivers.
How similar studies have performed: While the specific approach of using live music for this population is relatively novel, similar studies have shown positive effects of music interventions on emotional and cognitive outcomes in dementia care.
Eligibility criteria
Show full inclusion / exclusion 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) * Able to provide informed consent * Willing to wear an EEG headset and heart rate monitoring devices * Willing to possibly have small patches of body / facial hair shaved to accommodate administration of heart rate monitoring devices * Willing to answer survey questions about topics related to the study * Willing to be audio / video recorded 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 6 months * Prescribed Benzodiazepines on an as needed basis
Where this trial is running
New Haven, Connecticut and 1 other locations
- Firehouse 12 Studios — New Haven, Connecticut, United States (Recruiting)
- Musical Intervention Studios — New Haven, Connecticut, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: AZA Allsop, MD, PhD — Yale University
- Study coordinator: AZA Allsop, MD, PhD
- Email: Aza.allsop@yale.edu
- Phone: 240-422-3289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.