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NCT04666077 | RECRUITING | Alzheimer's Disease


Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Mary C Sano

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.

Condition or disease

Alzheimer's Disease

Mild Cognitive Impairment

Intervention/treatment

Home-based MT through Supervised, Supported Singing (H3S)

Individualized Music Therapy (IMT)

Attention Control (AtCon)

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : TRIPLE
Masking Description : All treatment arms will be conducted at the Louis Armstrong Center for Music and Medicine with staff at that location while screening and all outcome evaluations will be conducted at the Alzheimer's Disease Research Center at the Mount Sinai location. A single unblinded team member at each site will coordinate visits and data collection.
Primary Purpose : TREATMENT
Official Title : A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD
Actual Study Start Date : 2019-08-27
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

Location Details

NCT04666077


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Locations


RECRUITING

United States, New York

Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel

New York, New York, United States, 10003

RECRUITING

United States, New York

Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

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