Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
- Conditions
- Alzheimer's DiseaseMild Cognitive Impairment
- Interventions
- Behavioral: Home-based MT through Supervised, Supported Singing (H3S)Other: Attention Control (AtCon)Behavioral: Individualized Music Therapy (IMT)
- Registration Number
- NCT04666077
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive Impairment.
The 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with Alzheimer's disease and Mild Cognitive Impairment.
Following screening, all participants will meet with a licensed music therapist at the first study visit. Thereafter, each group will have an individualized schedule of follow-up telephone calls and visits.
Screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.
- Detailed Description
Interested participants and their study partner will be enrolled after an evaluation to determine cognitive impairment or mild dementia. The evaluation, either in person or remote, will include cognitive testing, clinical and neurological evaluation, a review medical records and medical history and an examination as deemed necessary by a dementia physician. Eligible participants will undergo baseline testing including linguistic analyses and will be randomly assigned to one of 3 intervention groups. Participants and their study partners will be contacted at least once every three months for cognitive testing and medical review. Contact with the music therapy team will occur up to twice per week but not less than once per month, for the first six months study enrollment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Diagnosis of Alzheimer's disease or mild cognitive impairment
- Must have study partner
- English speaking
- No verbal impairment
- Community-dwelling
- Must have webcam or smart phone
- A diagnosis of dementia other than probable or possible AD
- Probable AD with Down syndrome
- History of a clinically significant stroke with residual deficit
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury
- Current diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Participation in another interventional study
- Comorbidity causing disability interfering with intervention such as pain or discomfort or life expectancy less than 1 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-based MT through Supervised, Supported Singing (H3S) Home-based MT through Supervised, Supported Singing (H3S) Treatment arm 1 H3S and IMT Individualized Music Therapy (IMT) Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT) Attention Control (AtCon) Attention Control (AtCon) Comparison condition with comparable attention H3S and IMT Home-based MT through Supervised, Supported Singing (H3S) Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)
- Primary Outcome Measures
Name Time Method Clinician's Global Impression of Change (ADCS-CGIC) 12 months The Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change. (ADCS-CGIC) to assess cognition, behavior and function. Full scale from 1-7, higher score indicates poorer health outcome.
Mini Mental Status Exam (MMSE) 12 months Mini Mental Status Exam to assess cognition, behavior and function. Full score from 0-30, higher score indicates poorer health outcomes.
Neuropsychiatric Inventory (NPI) 12 months Neuropsychiatric Inventory to assess cognition, behavior and function. The total NPI score is 0-144, higher score indicates poorer health outcomes.
Activities of Daily Living (ADCS-ADL) 12 months The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) to assess cognition, behavior and function. The ADCS-ADL is a 23 item scale that includes 6 Basic ADL items and 17 Instrumental ADL items that provide a total score from 0-78, with a lower score indicating greater severity.
- Secondary Outcome Measures
Name Time Method Zarit Burden Interview 12 months Zarit Burden Interview.to assess caregiver burden. 22-item instrument, full score from 0-88, higher score indicates feeling more burden.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 12 months ADAS-Cog. to assess specific cognitive domains with composite scores of language, attention and executive function. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Trial Locations
- Locations (2)
Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel
🇺🇸New York, New York, United States