Alzheimer's Disease (AD)NCT07419022
Improv Music Therapy for Older Adults
A study testing Clinical Improvisation in people with Alzheimer's Disease (AD) and Older Adults (65 Years and Older), run by University of California, San Francisco at 1 site in United States.
Trial summary
Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD), Older Adults (65 Years and Older)
- What is being tested?
- Clinical Improvisation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for the Person Living with Dementia (PLWD) are:
- Age 60 and over, living independently in the community
- Medical diagnosis of Alzheimer's Disease
- Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24
- Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)
- English fluency rated fairly well to well (self-rated English fluency)
Show all 9Show fewer
- Age 18 or Older
- Moderate to good English fluency (self-rated English fluency)
- Willing to participate in intervention with PLWD
Who cannot join
- Medical diagnosis of severe dementia (any etiology)
- Non-AD dementia diagnosis (e.g., frontotemporal dementia)
- Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
- Significant difficulty moving the hands or arms (severe arthritis, neuropathy)
- Plans to move out of the area within six months
- Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
- Plans to move out of the area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners
Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.
- Being tested
- Clinical Improvisation
- Keywords
- music, improvisation, person living with dementia, caregiver, Alzheimer's Disease and related diseases, mechanism of behavior change, stress reduction, behavior change
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ImprovisationBehavioural
Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Clinical Improvisation Immediately Receives: Behavioral: Clinical Improvisation |
| Group B | Experimental | Delayed Onset Clinical improvisation Receives: Behavioral: Clinical Improvisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Science of Behavior Change (SOBC) Brief-COPE
The Brief COPE is a 28 item measure of strategies used for coping or regulating cognitions in response to stressors. The questions assess the frequency with which a person uses different coping strategies (e.g. "I've been turning to work or other activities to take my mind off strings") and the respondent gives a rating on a 5 item scale (1= I haven't been doing this at all to 4 I've been doing this a lot).
Measured: Baseline and Post-Intervention, 8 weeks
SOBC Perceived Stress Scale
The Perceived Stress Scale ask participants about their feelings and thoughts during the last month. There are 10 items and participants are asked how often they felt orr thought a certian way (0 = never to 4 very often)
Measured: Baseline and Post Intervention, 8 weeks
Secondary outcomes (4)
Dementia Mood Picture Test
Participants are given large line face drawings with large font descriptors. Participants are asked whether or not they are experiencing each mood ("Are you in a good mood?") and the intensity of the mood. The test assesses the PLWD directly but focuses on six primary moods.
Measured: Baseline and Post Intervention, 8 weeks
SOBC Positive and Negative Affect (PANAS)
The PANAS is a 20 item self-questionnaire. Respondent is asked to read several words which describe different feelings and emotions. Applicability of the emotion is scored by respondent on a 5 point Likert Scale (1 = very slightly or not at all to 5 = extremely). Higher scores on Positive Affect items incidate greater intensity of positive emotions and higher scores on Negative Affect indicate greater intensity of negative emotions.
Measured: Baseline and Post Intervention, 8 weeks
Neuropsychiatric Inventory (NPI-Q)
The NPI-Q is a 12-item questionnaire completed by the caregiver. Each question asks about a neuropsychiatric symptom over the previous month. The Caregiver can say "no" and go on to the next question. If the Caregiver says "yes", the caregive then rates the a) Severity of the symptoms present on a 3 point scale (1=mild to 3 = severe), and b) Distress experienced by the caregiver due to that symptom on a 5 point scale (0 = not distressing at all to 5 very distressing).
Measured: Baseline and Post Intervention, 8 weeks
Kingston Caregivers STress Scale
The KCSS is at 10 item questionnaire completed by a family caregiver. The questions ask caregivers to report feeling of stress surrounding specific aspects of caregiving. Caregivers respond using a 5 point scale (1 = no stress to 5 = extreme stress)
Measured: Baseline and Post-Intervention, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a waitlisted control pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karen Barrett, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419022
- Sponsor's protocol ID
- 5K01AG088475-02
- Other IDs
- 1K01AG088475-01A1
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT07419022
- Acronym / sponsor ID
- 5K01AG088475-02
- Keywords
- music, improvisation, person living with dementia, caregiver, Alzheimer's Disease and related diseases, mechanism of behavior change, stress reduction, behavior change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Feb 2026 (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.
Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a waitlisted control pilot study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Clinical ImprovisationClinical Improvisation Immediately |
| Group B | Experimental | Behavioral: Clinical ImprovisationDelayed Onset Clinical improvisation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 60 and over, living independently in the community
- Medical diagnosis of Alzheimer's Disease
- Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24
- Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)
- English fluency rated fairly well to well (self-rated English fluency)
Key exclusion criteria (8 listed)
- Medical diagnosis of severe dementia (any etiology)
- Non-AD dementia diagnosis (e.g., frontotemporal dementia)
- Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
- Significant difficulty moving the hands or arms (severe arthritis, neuropathy)
- Plans to move out of the area within six months
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 |
|---|---|---|
| Clinical ImprovisationClinical improvisation music therapy offered as group sessions delivered by board-certified music therapist. | Behavioural | Group A, Group B |
Primary outcome
Science of Behavior Change (SOBC) Brief-COPE
Time frame: Baseline and Post-Intervention, 8 weeks
The Brief COPE is a 28 item measure of strategies used for coping or regulating cognitions in response to stressors. The questions assess the frequency with which a person uses different coping strategies (e.g. "I've been turning to work or other activities to take my mind off strings") and the respondent gives a rating on a 5 item scale (1= I haven't been doing this at all to 4 I've been doing this a lot).
SOBC Perceived Stress Scale
Time frame: Baseline and Post Intervention, 8 weeks
The Perceived Stress Scale ask participants about their feelings and thoughts during the last month. There are 10 items and participants are asked how often they felt orr thought a certian way (0 = never to 4 very often)
4 secondary outcomes
Dementia Mood Picture Test
Time frame: Baseline and Post Intervention, 8 weeks
SOBC Positive and Negative Affect (PANAS)
Time frame: Baseline and Post Intervention, 8 weeks
Neuropsychiatric Inventory (NPI-Q)
Time frame: Baseline and Post Intervention, 8 weeks
Kingston Caregivers STress Scale
Time frame: Baseline and Post-Intervention, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- 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.
Karen Barrett, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Improvisation in people with Alzheimer's Disease (AD) and Older Adults (65 Years and Older), run by University of California, San Francisco at 1 site 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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen C Barrett, PhD (4153534501, Karen.Barrett@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Science of Behavior Change (SOBC) Brief-COPE (time frame: Baseline and Post-Intervention, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.