N/A
N=10
Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY
Alzheimer Disease · Dementia · Music Therapy
Bottom Line
View on ClinicalTrials.gov: NCT05309369 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) — 0; 0; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preferred Music (Behavioral); Nature Sounds (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) |
0; 0; 5; 2; 2; 0 | — |
| SECONDARY Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) |
3; 1; 1; 4; 5; 2 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05309369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.