Clinical trial NCT04666077: Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
Official title: A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: music
music therapy
memory
executive function
cognitive function
caregiver burden
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled 6 months (24 week) trial to assess the benefits of Homebased MT through Supervised, Supported Singing (H3S) vs control condition receiving attention (AtCon) in persons with ADRD or its prodrome (MCI). A randomized sub group will receive both the H3S and Individualized Music therapy (IMT) during for the same interval. Randomization to H3S, IMT, AtCon will be 2 to 1 to 2, with stratification of disease severity to insure equal representation across arms.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mini Mental Status Exam (MMSE)
timeFrame: 12 months
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 12 months
measure: Activities of Daily Living (ADCS-ADL)
timeFrame: 12 months
measure: Clinician's Global Impression of Change (ADCS-CGIC)
timeFrame: 12 months
Secondary outcomes:
measure: The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
timeFrame: 12 months
measure: Zarit Burden Interview
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mary Sano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Beth Israel
name: Joanne Loewy, DA, LCAT, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: