NCT05151562

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jul 2022Jun 2028

First Submitted

Initial submission to the registry

November 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

November 29, 2021

Last Update Submit

April 30, 2026

Conditions

Mild Cognitive ImpairmentAlzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline and Post-test Week 12

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

    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).

    Baseline and Post-test Week 12

Secondary Outcomes (7)

  • Change in cortical activation as assessed by Blood Oxygen Level Dependent (BOLD) on functional magnetic resonance imaging (fMRI)

    Baseline and Post-test Week 12

  • Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)

    Baseline and Post-test Week 12

  • Change in quality of life as assessed by the Quality of Life for Alzheimer's Disease (QoL-AD)

    Baseline and Post-test Week 12

  • Change in nostalgia level as assessed by Southampton Nostalgia Scale (SNS)

    Baseline and Post-test Week 12

  • Change in anxiety level as assessed by State-Trait Anxiety Inventory (STAI)

    Baseline and Post-test Week 12

  • +2 more secondary outcomes

Study Arms (1)

Virtual Music Therapy

EXPERIMENTAL

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

Behavioral: Virtual Music Therapy

Interventions

Virtual Music TherapyBEHAVIORAL

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.

Virtual Music Therapy

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-89
  • Mild Cognitive Impairment (MoCA score: 18-25) or Early AD (MoCA score: 17-24)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (10)

  • Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

    PMID: 9153155BACKGROUND

  • Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.

    PMID: 9236950BACKGROUND

  • Nutt D. The Hamilton Depression Scale--accelerator or break on antidepressant drug discovery? J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):119-20. doi: 10.1136/jnnp-2013-306984. No abstract available.

    PMID: 24443712BACKGROUND

  • Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

    PMID: 12021425BACKGROUND

  • Mullensiefen D, Gingras B, Musil J, Stewart L. The musicality of non-musicians: an index for assessing musical sophistication in the general population. PLoS One. 2014 Feb 26;9(2):e89642. doi: 10.1371/journal.pone.0089642. eCollection 2014.

    PMID: 24586929BACKGROUND

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND

  • Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory, C. A. Palo Alto, Ed. 1989.

    BACKGROUND

  • Gerdner LA, Hartsock J, Buckwalter KC. Assessment of personal music preference (family version). The University of Iowa Gerontological Nursing Interventions Research Center: Research Development and Dissemination Core, Iowa City, Iowa. 2000.

    BACKGROUND

  • Bunnell SL, Legerski JP, Herting NR. The autobiographical memory test: Differences in memory specificity across three recall elicitation methods. Current Psychology. 2018 Jul 18:1-8.

    BACKGROUND

  • Kelly L, Ahessy B. Reminiscence-Focused Music Therapy to Promote Positive Mood and Engagement and Shared Interaction for People Living With Dementia: An Exploratory Study. InVoices: A World Forum for Music Therapy 2021 Jul 1 (Vol. 21, No. 2). GAMUT-Grieg Academy Music Therapy Research Centre (NORCE & University of Bergen).

    BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Alexander Pantelyat, MD

    Department of Neurology, Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Pantelyat, MD

CONTACT

4105023290apantel1@jhmi.edu

Kyurim Kang, PhD

CONTACT

4437422223kkang19@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 9, 2021

Study Start

July 18, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)