Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers

NCT06940687 | Enrolling By Invitation

• 1 other identifier: 2000038702
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.

Conditions

Alzheimer Disease; Dementia; Mild Cognitive Impairment; Peer-bonded Caregiver; Caregiver

Keywords

Live Music; EEG; EKG/ECG; Anxiety; Connectedness; Social Connection

Outcome Measures

Primary Outcomes (8)

• Change in EEG activity during live music vs pre-recorded music conditions

  EEG gamma measured by the Post Spectral Density measures in the gamma range (\>30Hz) and theta (4-8Hz) frequency ranges during live music vs pre-recorded music conditions

  Day 1 and Day 2, an average of 1 week apart

• motion capture

  Capturing motion allows the researchers to investigate if patterns of bodily and stylistic characteristics of motion are associated with different emotional states in participants with Dementia and their caregivers. We will thematically analyze motion characteristics of and between individual participants during and between live and recorded music experiences using Laban Movement Analysis.

  Day 1 and Day 2, an average of 1 week apart

• facial action units

  Capturing facial expressions (i.e. facial action units) allows the researchers to study behavioral differences in emotion and arousal of and between individual participants exhibited during and between live and recorded music experiences.

  Day 1 and Day 2, an average of 1 week apart

• eye gaze

  Capturing eye gaze allows the researchers to study behavioral differences in attention and arousal of and between individual participants exhibited during and between live and recorded music experiences.

  Day 1 and Day 2, an average of 1 week apart

• Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).

  Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the standard deviation of Normal-to-Normal (SDNN) Interval in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. SDNN Intervals measure both sympathetic and parasympathetic nervous system (SNS \& PNS) responses (primarily sympathetic) in milliseconds.

  Day 1 and Day 2, an average of 1 week apart

• Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).

  Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the Root Mean Square of Successive Differences (RMSSD) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. RMSSD measure parasympathetic responses in milliseconds.

  Day 1 and Day 2, an average of 1 week apart

• Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).

  Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. VLF measure sympathetic responses in milliseconds squared.

  Day 1 and Day 2, an average of 1 week apart

• Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).

  Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the ratio of low frequency (sympathetic response) and high frequency (parasympathetic response). This unitless measure is abbreviated as LF/HF and informs the researchers about the relationship between the SNS and PNS.

  Day 1 and Day 2, an average of 1 week apart

Secondary Outcomes (8)

• music information retrieval (MIR) methods

  Day 1 and Day 2, an average of 1 week apart

• Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale

  Day 1 and Day 2, an average of 1 week apart

• Change in absorption in music using the Absorption in Music Scale (AIMS)

  Day 1 and Day 2, an average of 1 week apart

• Change in absorption in music using the Geriatric Anxiety Scale (GAS)

  Day 1 and Day 2, an average of 1 week apart

• Change in absorption in music using the State-Trait Anxiety Inventory (STAI)

  Day 1 and Day 2, an average of 1 week apart

Study Arms (1)

AD / Dementia / MCI participants and caregivers dyads with music

EXPERIMENTAL

Each participant will take part in two sessions. Both sessions will last up to 3 hours. Participants will attend a series of live music performances and pre-recorded control session performances. Physiological and survey data will be collected to assess the impact of live versus pre-recorded music on anxiety, social motivation, parasympathetic activity, and neural synchrony.

Behavioral: Pre-recorded Music Session; Behavioral: Live Music Session

Interventions

Pre-recorded Music Session BEHAVIORAL

A pre-recorded concert session

AD / Dementia / MCI participants and caregivers dyads with music

Live Music Session BEHAVIORAL

A 45-minute live music performance

AD / Dementia / MCI participants and caregivers dyads with music

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Renée Fleming Foundation: collaborator
• Yale University School of Medicine, Department of Psychiatry: collaborator
• Howard University: collaborator
• NeuroArts Blueprint Initiative: collaborator

Study Sites (2)

Firehouse 12 Studios

New Haven, Connecticut, 06510, United States

Location

Musical Intervention Studios

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• AZA Allsop, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators aim to enroll 30 early Alzheimer's (AD) / Dementia / Mild Cognitive Impairment (MCI) participants and their 30 caregivers (30 dyads). A target sample size of 60 participants is proposed with an upper limit of 120 participants enrolled to allow for the possibility of losing a portion of the sample to follow-up.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: April 23, 2025
• Study Start: January 28, 2025
• Primary Completion: March 22, 2026
• Study Completion: March 22, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)