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

NCT04666077 | Completed

• 1 other identifier: GCO 19-0243(0002)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Keywords

music; music therapy; memory; executive function; cognitive function; caregiver burden

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  12 months

• Zarit Burden Interview

  12 months

Study Arms (3)

Home-based MT through Supervised, Supported Singing (H3S)

EXPERIMENTAL

Treatment arm 1

Behavioral: Home-based MT through Supervised, Supported Singing (H3S)

H3S and IMT

EXPERIMENTAL

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); Behavioral: Individualized Music Therapy (IMT)

Attention Control (AtCon)

PLACEBO COMPARATOR

Comparison condition with comparable attention

Other: Attention Control (AtCon)

Interventions

Home-based MT through Supervised, Supported Singing (H3S) BEHAVIORAL

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.

H3S and IMT; Home-based MT through Supervised, Supported Singing (H3S)

Individualized Music Therapy (IMT) BEHAVIORAL

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.

H3S and IMT

Attention Control (AtCon) OTHER

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.

Attention Control (AtCon)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

  PMID: 40049590 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Caregiver Burden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Mary Sano, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Joanne Loewy, DA, LCAT, MT-BC

  Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All treatment arms will be conducted at the Louis Armstrong Center for Music and Medicine with staff at that location while screening and all outcome evaluations will be conducted at the Alzheimer's Disease Research Center at the Mount Sinai location. A single unblinded team member at each site will coordinate visits and data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Alzheimer's Disease Research Center

Model Details: This is a randomized, controlled 6 months (24 week) trial to assess the benefits of Homebased MT through Supervised, Supported Singing (H3S) vs control condition receiving attention (AtCon) in persons with ADRD or its prodrome (MCI). A randomized sub group will receive both the H3S and Individualized Music therapy (IMT) during for the same interval. Randomization to H3S, IMT, AtCon will be 2 to 1 to 2, with stratification of disease severity to insure equal representation across arms.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: August 27, 2019
• Primary Completion: July 15, 2025
• Study Completion: July 25, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)