Alzheimer's DiseaseNCT04666077
Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
A study testing Home-based MT through Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT) in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Home-based MT through Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2019to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel
New York, New York, 10003
Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD
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.
Read more
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.
Read the 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.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- Home-based MT through Supervised, Supported Singing (H3S), Individualized Music Therapy (IMT), Attention Control (AtCon)
- Keywords
- music, music therapy, memory, executive function, cognitive function, caregiver burden
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based MT through Supervised, Supported Singing (H3S)Behavioural
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.
Individualized Music Therapy (IMT)Behavioural
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.
Attention Control (AtCon)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based MT through Supervised, Supported Singing (H3S) | Experimental | Treatment arm 1 Receives: Behavioral: Home-based MT through Supervised, Supported Singing (H3S) |
| H3S and IMT | Experimental | Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT) Receives: Behavioral: Home-based MT through Supervised, Supported Singing (H3S); Behavioral: Individualized Music Therapy (IMT) |
| Attention Control (AtCon) | Placebo comparator | Comparison condition with comparable attention Receives: Other: Attention Control (AtCon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory to assess cognition, behavior and function. The total NPI score is 0-144, higher score indicates poorer health outcomes.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
Zarit Burden Interview
Zarit Burden Interview.to assess caregiver burden. 22-item instrument, full score from 0-88, higher score indicates feeling more burden.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start27 Aug 2019
- Primary completion15 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary C Sano, Icahn School of Medicine at Mount Sinai
- Investigators
- Mary Sano, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiJoanne Loewy, DA, LCAT, MT-BC, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666077
- Sponsor's protocol ID
- GCO 19-0243(0002)
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
PubMed 40049590
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD
- ClinicalTrials.gov ID
- NCT04666077
- Acronym / sponsor ID
- GCO 19-0243(0002)
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- music, music therapy, memory, executive function, cognitive function, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based MT through Supervised, Supported Singing (H3S) | Experimental | Behavioral: Home-based MT through Supervised, Supported Singing (H3S)Treatment arm 1 |
| H3S and IMT | Experimental | Behavioral: Home-based MT through Supervised, Supported Singing (H3S), Behavioral: Individualized Music Therapy (IMT)Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT) |
| Attention Control (AtCon) | Placebo comparator | Other: Attention Control (AtCon)Comparison condition with comparable attention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Alzheimer's disease or mild cognitive impairment
- Must have study partner
- English speaking
- No verbal impairment
- Community-dwelling
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based MT through Supervised, Supported Singing (H3S)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. | Behavioural | H3S and IMT, Home-based MT through Supervised, Supported Singing (H3S) |
| Individualized Music Therapy (IMT)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. | Behavioural | H3S and IMT |
| Attention Control (AtCon)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. | Other | Attention Control (AtCon) |
Primary outcome
Mini Mental Status Exam (MMSE)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Clinician's Global Impression of Change (ADCS-CGIC)
Time frame: 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.
2 secondary outcomes
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: 12 months
Zarit Burden Interview
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 40049590van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Sano, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Joanne Loewy, DA, LCAT, MT-BC principal investigator
Mount Sinai Beth Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based MT through Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT) in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Status Exam (MMSE) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.