Recruiting

Music Therapy

Sponsor:

Johns Hopkins University

Code:

NCT05151562

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual Music Therapy

Study Details

Brief summary:

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.

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Study ID

NCT05151562

Start date

Jul 18, 2022

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-89
  • 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
  • Exclusion Criteria will be carefully determined by the MRI screening form.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Music Therapy

Participants will attend two 30 minutes long virtual music therapy sessions per week for 8 weeks using Zoom.

Interventions

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 measure

  • Change in autobiographical memory level as assessed by Autobiographical Memory Test (AMT) [ Time Frame: Baseline and Post-test Week 12 ]
  • Change in scores on neuropsychiatric symptom level as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q) (caregivers) [ Time Frame: Baseline and Post-test Week 12 ]

Central Contacts and Locations

Central contacts

Alexander Pantelyat, MD

4105023290apantel1@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Alexander Pantel, MD

apantel1@jhmi.edu

Kyurim Kang, PhD

kkang19@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Mild Cognitive Impairment (MCI)
  • Alzheimer's Disease (AD)
  • functional magnetic resonance imaging (fMRI)
  • Autobiographical memory
  • Virtual Music Therapy
  • Music Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-06.