Mild Cognitive Impairment (MCI)M4MNCT06866327
Music for the Mind Study
A study testing Piano lessons and Music Lessons in people with Mild Cognitive Impairment (MCI) and Memory Disorders, Age Related, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Memory Disorders, Age Related, Memory Decline
- What is being tested?
- Piano lessons and Music Lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Music Training Programs Among Older Adults Living With Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
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?
Read more
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.
- Being tested
- Piano lessons, Music Lessons
- Keywords
- music, memory, mood, emotion, well-being
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piano lessonsBehavioural
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.
Music LessonsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Piano lessons | Experimental | Introduction to piano playing, including instruction and practice in note reading, finger positions, and song playing. Receives: Behavioral: Piano lessons |
| Music lessons | Active comparator | Introduction to varied instrument playing, music singing, and music appreciation. Receives: Behavioral: Music Lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This outcome is measured by a 6-item self-reported Credibility/ Expectancy Questionnaire (CEQ) that measure participants' views about the expected efficacy of the 12-week program they are randomly assigned to.
Measured: At enrollment
Percent of participants who are approached and consent to the study
The proportion of participants are approached and consenting to the study. Feasibility of recruitment is defined as > 50% of screened participants consenting to enroll.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start24 Feb 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eastman Performing Arts Medicine Center, University of Rochester Aging Institute, University of Rochester School of Nursing
- Responsible party
- Principal investigator, Kathi Heffner, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866327
- Sponsor's protocol ID
- STUDY00010048
- Acronym
- M4M
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Music Training Programs Among Older Adults Living With Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06866327
- Acronym / sponsor ID
- M4M / STUDY00010048
- Keywords
- music, memory, mood, emotion, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eastman Performing Arts Medicine Center, University of Rochester Aging Institute, University of Rochester School of Nursing
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piano lessons | Experimental | Behavioral: Piano lessonsIntroduction to piano playing, including instruction and practice in note reading, finger positions, and song playing. |
| Music lessons | Active comparator | Behavioral: Music LessonsIntroduction to varied instrument playing, music singing, and music appreciation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piano lessonsThe 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. | Behavioural | Piano lessons |
| Music LessonsThe 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. | Behavioural | Music lessons |
Primary outcome
Percent of participants who complete the 12-week program they are randomly assigned to
Time frame: From enrollment to the end of the program at 12 weeks
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.
2 secondary outcomes
Expectancy of the 12-week program they are randomly assigned to
Time frame: At enrollment
Percent of participants who are approached and consent to the study
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piano lessons and Music Lessons in people with Mild Cognitive Impairment (MCI) and Memory Disorders, Age Related, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who complete the 12-week program they are randomly assigned to (time frame: From enrollment to the end of the program at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.