Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD

This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive Impairment.

The 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with Alzheimer's disease and Mild Cognitive Impairment.

Following screening, all participants will meet with a licensed music therapist at the first study visit. Thereafter, each group will have an individualized schedule of follow-up telephone calls and visits.

Screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Home-based MT through Supervised, Supported Singing (H3S); Behavioral: Individualized Music Therapy (IMT); Other: Attention Control (AtCon)

Detailed Description

Interested participants and their study partner will be enrolled after an evaluation to determine cognitive impairment or mild dementia. The evaluation, either in person or remote, will include cognitive testing, clinical and neurological evaluation, a review medical records and medical history and an examination as deemed necessary by a dementia physician. Eligible participants will undergo baseline testing including linguistic analyses and will be randomly assigned to one of 3 intervention groups. Participants and their study partners will be contacted at least once every three months for cognitive testing and medical review. Contact with the music therapy team will occur up to twice per week but not less than once per month, for the first six months study enrollment.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeleine Dauray; Phone Number: 212-241-8329; Email: adeleine.dauray@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel
      • Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC
    • New York, New York, United States, 10029
      • Recruiting
      • Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Mary Sano, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Alzheimer's disease or mild cognitive impairment
• Must have study partner
• English speaking
• No verbal impairment
• Community-dwelling
• Must have webcam or smart phone

Exclusion Criteria:

• A diagnosis of dementia other than probable or possible AD
• Probable AD with Down syndrome
• History of a clinically significant stroke with residual deficit
• Current evidence or history in past two years of epilepsy, focal brain lesion, head injury
• Current diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
• Participation in another interventional study
• Comorbidity causing disability interfering with intervention such as pain or discomfort or life expectancy less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based MT through Supervised, Supported Singing (H3S); Treatment arm 1	Behavioral: Home-based MT through Supervised, Supported Singing (H3S); Daily singing of "song of kin". The song of kin will be derived from an assessment session and evaluation inclusive of an interview under the supervision of Dr. Joanne Loewy and her team at the Louis Armstrong Center for Music and Medicine (LACMM). The interview will include the participant and their study partner who will assist in identifying musical preferences and relevant cultural experiences. A recording of prescribed song protocols will be provided. Participants and study partners will be directed to plan a minimum of 1 hour a day in which the participant will sing along with the study partner-administered song of kin. A diary will be provided to the study partner to record the time of day, amount of time spent and comments on the activity. Study staff will contact the members of this group to confirm compliance with the activity.
Experimental: H3S and IMT; Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)	Behavioral: Home-based MT through Supervised, Supported Singing (H3S); Daily singing of "song of kin". The song of kin will be derived from an assessment session and evaluation inclusive of an interview under the supervision of Dr. Joanne Loewy and her team at the Louis Armstrong Center for Music and Medicine (LACMM). The interview will include the participant and their study partner who will assist in identifying musical preferences and relevant cultural experiences. A recording of prescribed song protocols will be provided. Participants and study partners will be directed to plan a minimum of 1 hour a day in which the participant will sing along with the study partner-administered song of kin. A diary will be provided to the study partner to record the time of day, amount of time spent and comments on the activity. Study staff will contact the members of this group to confirm compliance with the activity.; Behavioral: Individualized Music Therapy (IMT); The Individualized Music therapy (IMT) conducted by the LACMM staff. It will be administered by a certified music therapist twice weekly for 45 minutes. The sessions will employ extensive clinical improvisation based on the songs of kin utilized in the H3S condition. Compliance will be measured with a weekly log which will record dates and times of each condition.
Placebo Comparator: Attention Control (AtCon); Comparison condition with comparable attention	Other: Attention Control (AtCon); The attention control (AtCon) will meet with the LACMM team for an interview in which they will be asked about music preferences and music experiences. They will answer any questions from participant and caregiver about music experiences. Study staff will contact the members of this group at the same schedule as the H3S group to assess music activity engagement. This will measure unplanned exposure and minimize "drop-in" music activity which could contaminate the control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental Status Exam (MMSE)	Mini Mental Status Exam to assess cognition, behavior and function. Full score from 0-30, higher score indicates poorer health outcomes.	12 months
Neuropsychiatric Inventory (NPI)	Neuropsychiatric Inventory to assess cognition, behavior and function. The total NPI score is 0-144, higher score indicates poorer health outcomes.	12 months
Activities of Daily Living (ADCS-ADL)	The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) to assess cognition, behavior and function. The ADCS-ADL is a 23 item scale that includes 6 Basic ADL items and 17 Instrumental ADL items that provide a total score from 0-78, with a lower score indicating greater severity.	12 months
Clinician's Global Impression of Change (ADCS-CGIC)	The Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change. (ADCS-CGIC) to assess cognition, behavior and function. Full scale from 1-7, higher score indicates poorer health outcome.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)	ADAS-Cog. to assess specific cognitive domains with composite scores of language, attention and executive function. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.	12 months
Zarit Burden Interview	Zarit Burden Interview.to assess caregiver burden. 22-item instrument, full score from 0-88, higher score indicates feeling more burden.	12 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mary Sano, PhD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC, Mount Sinai Beth Israel

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: memory; caregiver burden; cognitive function; music; music therapy; executive function
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: GCO 19-0243(0002)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No