Clinical trial NCT06866327: Music for the Mind Study
Official title: Feasibility and Acceptability of Music Training Programs Among Older Adults Living with Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Memory Disorders, Age Related
Memory Decline
Keywords: music
memory
mood
emotion
well-being
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Eastman Performing Arts Medicine Center
name: University of Rochester Aging Institute
name: University of Rochester School of Nursing
First posted: 2025-03-10
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this pilot clinical trial is to learn if older adults with mild cognitive impairment (MCI) find two music programs equally acceptable. This pilot study will help researchers prepare for a future, large-scale clinical trial to learn if music training can slow cognitive decline and promote emotional well-being in those at risk for Alzheimer's disease and related dementias. The main questions this pilot study aims to answer are:

* Do participants like the music programs?
* Do participants stay enrolled in the study?
* Do participants report perceived benefits of the programs for their emotional well-being or everyday memory?

Participants will:

* Participate in 12-weekly sessions of piano lessons or music lessons, with group and individual lessons alternating each week.
* Have home practice in between lessons, with a keyboard or other instruments provided.
* Keep a diary of their home practice and their mood before and after practice.
* Participate in interviews before and after the 12-week programs.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 60 years
* English-speaking
* Community-dwelling
* Medical diagnosis of MCI by a physician or research diagnostic criteria for MCI, defined by having Montreal Cognitive Assessment (MoCA), with a cutoff of 20- 25 (further adjusted for racial/ethnic differences)
* Capable to consent as identified by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
* No severe psychiatric condition (e.g., bipolar disorder)

Exclusion Criteria:

* Demonstrate musicality knowledge, as assessed by the Musicality Assessment developed by the study team
* Currently participating in a formal music activity (performance, classes, lessons, etc.)
* Major impairment in eyesight or hearing that precludes music reading, hearing, or engagement in the class
* Any difficulty using a keyboard (portable electric piano) due to pain, neuropathy, tremor, or upper finger/hand/limb injury

Primary outcomes:
measure: Percent of participants who complete the 12-week program they are randomly assigned to
timeFrame: From enrollment to the end of the program at 12 weeks
Secondary outcomes:
measure: Expectancy of the 12-week program they are randomly assigned to
timeFrame: At enrollment
measure: Percent of participants who are approached and consent to the study
timeFrame: At enrollment
Other outcomes:
measure: Acceptability of the 12-week program they are randomly assigned to
timeFrame: At enrollment, at the end of the program at 12 weeks
measure: Satisfaction of the 12-week program they are randomly assigned to
timeFrame: At the end of the program at 12 weeks
Locations:
city: Rochester
country: United States
facility: School of Nursing
state: New York
Study officials:
References: