NCT04666077

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-08-27
• Primary completion: 2025-07-15
• Completion: 2025-07-25
• First posted: 2020-12-14
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States