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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based MT through Supervised, Supported Singing (H3S)
Individualized Music Therapy (IMT)
Attention Control (AtCon)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring music, music therapy, memory, executive function, cognitive function, caregiver burden

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louis Armstrong Center for Music and Medicine, Mount Sinai Beth IsraelRecruiting
  • Alzheimer's Disease Research Center, Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

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

H3S and IMT

Attention Control (AtCon)

Arm Description

Treatment arm 1

Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)

Comparison condition with comparable attention

Outcomes

Primary Outcome Measures

Mini Mental Status Exam (MMSE)
Mini Mental Status Exam to assess cognition, behavior and function. Full score from 0-30, higher score indicates poorer health outcomes.
Neuropsychiatric Inventory (NPI)
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)
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.
Clinician's Global Impression of Change (ADCS-CGIC)
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.

Secondary Outcome Measures

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
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.
Zarit Burden Interview
Zarit Burden Interview.to assess caregiver burden. 22-item instrument, full score from 0-88, higher score indicates feeling more burden.

Full Information

First Posted
December 7, 2020
Last Updated
May 10, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04666077
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
music, music therapy, memory, executive function, cognitive function, caregiver burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based MT through Supervised, Supported Singing (H3S)
Arm Type
Experimental
Arm Description
Treatment arm 1
Arm Title
H3S and IMT
Arm Type
Experimental
Arm Description
Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)
Arm Title
Attention Control (AtCon)
Arm Type
Placebo Comparator
Arm Description
Comparison condition with comparable attention
Intervention Type
Behavioral
Intervention Name(s)
Home-based MT through Supervised, Supported Singing (H3S)
Intervention Description
Daily singing of "song of kin". The song of kin will be derived from an assessment session and evaluation inclusive of an interview under the supervision of Dr. Joanne Loewy and her team at the Louis Armstrong Center for Music and Medicine (LACMM). The interview will include the participant and their study partner who will assist in identifying musical preferences and relevant cultural experiences. A recording of prescribed song protocols will be provided. Participants and study partners will be directed to plan a minimum of 1 hour a day in which the participant will sing along with the study partner-administered song of kin. A diary will be provided to the study partner to record the time of day, amount of time spent and comments on the activity. Study staff will contact the members of this group to confirm compliance with the activity.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Music Therapy (IMT)
Intervention Description
The Individualized Music therapy (IMT) conducted by the LACMM staff. It will be administered by a certified music therapist twice weekly for 45 minutes. The sessions will employ extensive clinical improvisation based on the songs of kin utilized in the H3S condition. Compliance will be measured with a weekly log which will record dates and times of each condition.
Intervention Type
Other
Intervention Name(s)
Attention Control (AtCon)
Intervention Description
The attention control (AtCon) will meet with the LACMM team for an interview in which they will be asked about music preferences and music experiences. They will answer any questions from participant and caregiver about music experiences. Study staff will contact the members of this group at the same schedule as the H3S group to assess music activity engagement. This will measure unplanned exposure and minimize "drop-in" music activity which could contaminate the control condition.
Primary Outcome Measure Information:
Title
Mini Mental Status Exam (MMSE)
Description
Mini Mental Status Exam to assess cognition, behavior and function. Full score from 0-30, higher score indicates poorer health outcomes.
Time Frame
12 months
Title
Neuropsychiatric Inventory (NPI)
Description
Neuropsychiatric Inventory to assess cognition, behavior and function. The total NPI score is 0-144, higher score indicates poorer health outcomes.
Time Frame
12 months
Title
Activities of Daily Living (ADCS-ADL)
Description
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.
Time Frame
12 months
Title
Clinician's Global Impression of Change (ADCS-CGIC)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Description
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.
Time Frame
12 months
Title
Zarit Burden Interview
Description
Zarit Burden Interview.to assess caregiver burden. 22-item instrument, full score from 0-88, higher score indicates feeling more burden.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeleine Dauray
Phone
212-241-8329
Email
adeleine.dauray@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sano, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA, LCAT, MT-BC
Organizational Affiliation
Mount Sinai Beth Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA, LCAT, MT-BC
Facility Name
Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Sano, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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