Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY

Study Overview
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Brief Summary
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This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.

Detailed Description
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In partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. The tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. The pieces will be restricted in duration to between 1.5 and 2 minutes each. A piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. The total exposure time will be 10 minutes each hour over a three-hour period. The melody will be repeated as many times as necessary to complete the 10-minute period. The control intervention will involve listening to nature sounds at the same duration and administration scheme. Functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings.

Official Title
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Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY

Conditions
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Alzheimer Disease, Dementia, Music Therapy

Intervention / Treatment
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* Behavioral: Preferred Music
* Behavioral: Nature Sounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Person of any sex/gender aged between 55 and 90 Stated willingness to comply with all study procedures and availability for the duration of the study In the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver) Suffer from moderate to severe Alzheimer's disease as established by the study team using the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria for possible and probable Alzheimer's Disease Diagnosis of Alzheimer's disease or other type of dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Mini Mental State Examination (MMSE) score of 5-20 Subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner. Exclusion Criteria: Suffer from severe hearing impairment as reported by the informant Presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the Principal Investigator, including history of agitation and/or combative behavior. Individuals who score ≥ 12 seconds on the Timed Up and Go (TUG) Test.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preferred Music - Visit 1, Nature Sounds - Visit 2<br> | Behavioral: Preferred Music<br>* Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours<br>Behavioral: Nature Sounds<br>* Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours<br>|
| Placebo Comparator: Nature Sounds - Visit 1, Preferred Music - Visit 2<br> | Behavioral: Preferred Music<br>* Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours<br>Behavioral: Nature Sounds<br>* Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC). | This is a 7-item score ranging from markedly worse to markedly improved. It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input. | Visit 1 (Day 14 +/- 3 days) and Visit 2 (Day 21 +/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from Feeling active, vital, alert, or wide awake to No longer fighting sleep, sleep onset soon; having dream-like thoughts. | Visit 1 (Day 14 +/- 3 days) and Visit 2 (Day 21 +/- 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer Disease, Brain stimulation, Music