NCT06866327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 4, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

musicmemorymoodemotionwell-being

Outcome Measures

Primary Outcomes (1)

  • Percent of participants who complete the 12-week program they are randomly assigned to

    The proportion of participants who complete the program. Feasibility of retention is defined as \> 80% of enrolled participants in each group complete at least 10 lesson sessions.

    From enrollment to the end of the program at 12 weeks

Secondary Outcomes (2)

  • Expectancy of the 12-week program they are randomly assigned to

    At enrollment

  • Percent of participants who are approached and consent to the study

    At enrollment

Other Outcomes (2)

  • Acceptability of the 12-week program they are randomly assigned to

    At enrollment, at the end of the program at 12 weeks

  • Satisfaction of the 12-week program they are randomly assigned to

    At the end of the program at 12 weeks

Study Arms (2)

Piano lessons

EXPERIMENTAL

Introduction to piano playing, including instruction and practice in note reading, finger positions, and song playing.

Behavioral: Piano lessons

Music lessons

ACTIVE COMPARATOR

Introduction to varied instrument playing, music singing, and music appreciation.

Behavioral: Music Lessons

Interventions

Piano lessonsBEHAVIORAL

The program consists of 12-weekly piano lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn note reading, finger positioning, and song playing. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with a keyboard and bench provided.

Piano lessons
Music LessonsBEHAVIORAL

The program consists of 12-weekly music lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn various instruments, engage in group playing during group lessons, and engage in music appreciation activities. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with instruments provided.

Music lessons

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionMemory Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

February 24, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

April 8, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations