Clinical trial NCT05151562: Music Therapy for Patients With Alzheimer's Disease
Official title: Music Therapy for Autobiographical Memory and Neuropsychiatric Symptoms in Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: Mild Cognitive Impairment (MCI)
Alzheimer's Disease (AD)
functional magnetic resonance imaging (fMRI)
Autobiographical memory
Virtual Music Therapy
Music Therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Despite advancements in mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) treatment, patients who live with these symptoms still have many unmet neuropsychiatric needs. In investigating holistic approaches to treatment generally, it is important to utilize non-pharmacological interventions.

Kelly and Ahessy implemented reminiscence-focused group music therapy to promote positive mood and engagement through musical expression (e.g. singing, moving, body percussion) and verbal interaction, using thematic sessions that reflected the music preferences of the participants. The researchers found that a balance of familiar structures, such as greeting and ending songs, paired with adaptability on behalf of the music facilitator created meaningful space for reminiscence and shared engagement. The researchers also identify music as a core element that facilitated the sharing musical and extramusical personal memories, as well as provided grounding and opportunities for re-connection during moments of disorientation within the group.

Although use of virtual music therapy due to COVID-19 has been increased, the impact of virtual music therapy sessions on reminiscence is minimally explored in the literature. A clear benefit of virtual music therapy is increased access to care for participants living in rural areas or for whom travel is difficult, enabling participation in meaningful interventions without disrupting daily routines. Additionally, the ability to engage in music therapy from the familiarity of one's own home has been shown to facilitate relationship development between patients with dementia and the patients' caregivers, as well as increase feelings of comfort and relaxation.

The present study seeks to expand upon previous work by adding a layer of personalization and engagement. Rather than simply assigning individuals a regimen of music listening, the investigators will engage participants in regularly occurring virtual music therapy sessions centered on playing familiar songs live and stimulating reminiscence through autobiographical conversation. Such a study offers several advantages over previous similar studies' formats as it (a) allows researchers to maintain maximum control over how the treatment is administered, (b) saves participants and caregivers the stress of traveling for therapy (especially pertinent given the study's older demographic), (c) allows participants autonomy over when and where the participants engage in therapy, likely from the comfort of home, and (d) provides opportunities for music therapy to become a meaningful twice-weekly routine for both participants and the participants' care partners. Appreciating music is far greater than simply listening to it, and this study seeks to utilize the transformative power of individualized live music therapy interventions.

Participants with MCI or mild dementia due to AD will attend 30-minute reminiscence-targeted virtual music therapy during an 8 week, twice-weekly course of music therapy (a total of 16 sessions) through a Zoom. Participants' cognitive, anxiety, quality of life, and autobiographical memory level will be measured pre- and post- 16 virtual music therapy sessions. Brain activation patterns using functional magnetic resonance imaging (fMRI) will be compared before and after virtual music therapy sessions to understand if individualized virtual music therapy sessions can change cortical activity.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in autobiographical memory level as assessed by Autobiographical Memory Test (AMT)
timeFrame: Baseline and Post-test Week 12
measure: Change in scores on neuropsychiatric symptom level as assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q) (caregivers)
timeFrame: Baseline and Post-test Week 12
Secondary outcomes:
measure: Change in cortical activation as assessed by Blood Oxygen Level Dependent (BOLD) on functional magnetic resonance imaging (fMRI)
timeFrame: Baseline and Post-test Week 12
measure: Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and Post-test Week 12
measure: Change in quality of life as assessed by the Quality of Life for Alzheimer's Disease (QoL-AD)
timeFrame: Baseline and Post-test Week 12
measure: Change in nostalgia level as assessed by Southampton Nostalgia Scale (SNS)
timeFrame: Baseline and Post-test Week 12
measure: Change in anxiety level as assessed by State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline and Post-test Week 12
measure: Change in depression level as assessed by Geriatric Depression Scale (GDS)
timeFrame: Baseline and Post-test Week 12
measure: Change in score/statement on music therapy experiences as assessed by the structured interview reporting form
timeFrame: Day 1, Day 3, Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, Day 29, Day 31, Day 36, Day 38, Day 43, Day 45, Day 50, Day 52
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Department of Neurology, Johns Hopkins School of Medicine
name: Alexander Pantelyat, MD
role: PRINCIPAL_INVESTIGATOR
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