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NCT05151562 · Johns Hopkins University

Music Therapy for Patients With Alzheimer's Disease

What this study is about

This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, mood, and cognition in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD).

View original scientific description

This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, mood, and cognition in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD). 60 patients with MCI or mild dementia due to AD will receive two 30 minutes reminiscence-targeted virtual music therapy interventions per week for 8 weeks (a total of 16 sessions). Participants' (or supported by the study partner) self-reported and measurable outcomes including cognitive, anxiety, quality of life, and autobiographical memory will be assessed before and after the 8-week course of treatment. Blood-oxygenation level-dependent (BOLD) in functional magnetic resonance imaging (fMRI) will also be also measured before and after the 8-week course of treatment.

Interventions

BEHAVIORAL

Virtual Music Therapy

Each study participant will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be delivered by a board-certified music therapist (using Zoom as a primary platform). These individualized therapeutic encounters will use music that is personally meaningful and familiar to the participant and the participant's loved ones to facilitate reminiscence. Decision-making processes made by the music therapist will reflect a flexible session structure and series of intervention choices contingent on each participant's cultural identity, expressive and receptive communication, fine and gross motor ability, affect, orientation to time and place, and personal preferences on any given day.

Primary outcome measures

Change in autobiographical memory level as assessed by Autobiographical Memory Test (AMT)

Time frame: Baseline and Post-test Week 12

AMT is used to assess the degree of specificity of autobiographical memory. The AMT usually contains cue words of both positive and negative valence, but it is unclear whether these valences form separate factors or not. Participants are asked to generate a specific memory that happened on a particular day at least one week ago. The number of specific memories recalled on each AMT is used as the dependent variable, and a higher frequency indicates a greater autobiographical memory level. Scores are on a scale from 1 to 7, where higher scores indicate greater familiarity/imageability.

Change in scores on neuropsychiatric symptom level as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q) (caregivers)

Time frame: Baseline and Post-test Week 12

The NPI-Q is designed to be a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe; total score range: 0 - 36) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress; total score range: 0-60).

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Mild Cognitive Impairment (MoCA score: 18-25) or Early AD (MoCA score: 17-24)

Exclusion criteria

  • Head trauma, traumatic brain injury, or concussion with loss of consciousness for \>2 minutes
  • Claustrophobia incompatible with MRI scanning
  • Medical device incompatible with MRI scanning (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant)
  • Prior history as a metal worker and/or certain metallic objects in the body

Where

  • Baltimore, Maryland

Related conditions & keywords

Mild Cognitive ImpairmentAlzheimer DiseaseMild Cognitive Impairment (MCI)Alzheimer's Disease (AD)functional magnetic resonance imaging (fMRI)Autobiographical memoryVirtual Music TherapyMusic Therapy

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations

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1 of 60 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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Available
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Virtual Participation

Participate from home

Remote participation via telemedicine and home visits

RECRUITING

Baltimore

Maryland

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Mild Cognitive Impairment Treatment in Baltimore?

Join others in Maryland exploring innovative treatment options through clinical research

Mild Cognitive Impairment Treatment Options in Baltimore, Maryland

If you're searching for Mild Cognitive Impairment treatment in Baltimore, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Baltimore and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Mild Cognitive Impairment. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Mild Cognitive Impairment?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Mild Cognitive Impairment

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Mild Cognitive Impairment Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05151562. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.