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Frontotemporal DementiaNCT06768996

Music, Social Attention, and Dementia

A study testing Synchronous Rhythm Production and Solo Rhythm Production in people with Frontotemporal Dementia and Alzheimer Disease, run by University of California, San Francisco at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an exploratory mixed-methods control-treatment study to evaluate if participation in rhythmic musical activities improves social attention and connectedness in individuals living with mild to moderate bvFTD and AD, and their caregivers. Read more about this study

Who is it for?
Ages 55 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Frontotemporal Dementia, Alzheimer Disease
What is being tested?
Synchronous Rhythm Production and Solo Rhythm Production
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
10 Jan 2025to 1 Dec 2026
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 55 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 55 years of age living with bvFTD; or ≥ 70 years of age living with AD.
  • Documentation of a bvFTD or AD diagnosis as evidenced by one or more known clinical features.
  • Written informed consent obtained from subject.
  • Male or female ≥ 55 years of age living without diagnosis of neurological or psychiatric disease.
  • Individual capable of independent execution of activities of daily living, including personal care and hygiene, dressing, eating, use of a toilet, and mobility.
  • Written informed consent.

Who cannot join

  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • community-dwelling individuals not living with bvFTD
  • community-dwelling individuals with normal cognitive functioning
  • Individuals living with Alzheimer's disease or related dementias (primary progressive aphasia, semantic variant FTD, Lewy body dementia, vascular dementia, Parkinson's disease, or mixed dementia)
  • Individuals with a score of 2 or higher on the CDR
  • Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms.
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  • Individuals with unstable (e.g., cancer other than basal cell skin) or chronic (e.g., severe diabetes) medical conditions
  • Individuals with MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI)
  • Individuals with physical impairment(s) precluding motor response
  • Individuals with inability to walk two blocks without stopping
  • Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (~60 dB)
  • Individuals who practice music making or production for at least 30-mins per week
  • This may include instrumental or vocal, writing or arranging, alone or in groups
  • Listening to music for more than 30-mins weekly will not exclude the individual from the study
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Community-dwelling individuals living with diagnosis of a neurological or psychiatric disease
  • o Community-dwelling individuals with abnormal cognitive functioning
  • Individuals living with dementia
  • Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms
  • Individuals with unstable (e.g., cancer other than basal cell carcinoma) or chronic (e.g., severe diabetes) medical conditions
  • Individuals with physical impairment(s) precluding motor control
  • Individuals with inability to walk two blocks without stopping
  • Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (~60 dB)
  • Individuals who practice music making or production for at least 30-mins per week
  • This may include instrumental or vocal, writing or arranging, alone or in groups
  • Listening to music for more than 30-mins weekly will not exclude the individual from the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sandler Neurosciences Center

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: The Impact of a Caregiver-patient Music Intervention on Social Attention and Connectedness in Persons Living With bvFTD and AD

This is an exploratory mixed-methods control-treatment study to evaluate if participation in rhythmic musical activities improves social attention and connectedness in individuals living with mild to moderate bvFTD and AD, and their caregivers. Secondary objectives include evaluating the potential relationships between brain networks associated with rhythm production, social attention, and connectedness in these populations.

Read the detailed description

The proposed research will evaluate potential relationships between synchronous rhythm production, social attention, and connectedness in persons living with mild to moderate bvFTD and AD and their caregivers. To evaluate these relationships, the proposed research will include data collection and analysis of the following: 1) pre-post evaluation of social attention and connectedness in individuals living with dementia and their caregivers; 2) control-treatment participation in a synchronous (treatment) or solo (control) rhythm production activity; and 3) secondary analysis of structural and functional MRI of resting state network connectivity between networks of the brain including areas associated with rhythm perception and production, namely the fronto-parietal, executive control, sensorimotor, dorsal and ventral attention networks.

Being tested
Synchronous Rhythm Production, Solo Rhythm Production
Medical subject headings
Frontotemporal Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synchronous Rhythm ProductionBehavioural

    The treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.

  • Solo Rhythm ProductionBehavioural

    Participants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.

Study groups in NCT06768996
Study groupRoleWhat they receive
Solo Rhythm ProductionActive comparatorParticipants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.
Receives: Behavioral: Solo Rhythm Production
Synchronous Rhythm ProductionExperimentalThe treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.
Receives: Behavioral: Synchronous Rhythm Production

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Attention (TASIT)

    Dependent Variable. Change in social attention will be measured by the TASIT, a 16-item instrument that measures social attention from the care recipient perspective. Items are sectioned by emotion recognition, social inference minimum (sarcasm) or enriched (lies) and assessed using standardized yes-no questions at the end of each section based on four types: think, feel, say, or do.

    Measured: Baseline, 2-weeks

  2. Degree of rhythmic synchronization between dyad-pairs as determined by autocorrelated inter-tap intervals

    Independent variable. Degree of rhythmic synchronization will be measured via a musical instrument, digital interface (MIDI) and assessed using an automated data analysis tool created explicitly for the purposes of this study.

    Measured: Through study completion, an average of one year

  3. Caregiver perceived connectedness questionnaire

    A 1-item, 1-7 Likert based scale (1 = very disconnected ... 7 = very connected)

    Measured: Baseline, 2-weeks

  4. Mutuality Scale

    A 15-item instrument using a 0-4 Likert (0 = not at all … 4 = a great deal) that measures mutuality from the caregiver perspective. Examples include "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?"

    Measured: Baseline, 2-weeks

  5. Zarit burden

    A 12-item instrument using a 0-4 Likert (0 = never … 4 = nearly always) that measures burden from the caregiver perspective. An example is "Do you feel that your social life has suffered because you are caring for your relative?"

    Measured: Baseline, 2-weeks

  6. Positive and Negative Experience

    A 12-item instrument using a 1-5 Likert (1 = very rarely or never … 5 = very often or always) that measures an overall affect score that can also be divided into positive and negative feelings. It measures how the participant has felt over the past 4-weeks.

    Measured: Baseline, 2-weeks

  7. Positive Aspects of Caregiving

    A 9-item instrument using a 1-5 Likert (1 = disagree a lot … 5 = agree a lot) that measures a caregiver's perceptions of their positive experiences in caregiving for their care recipient. An example is "Providing help to [enter name of care recipient] has made me feel more useful."

    Measured: Baseline, 2-weeks

  8. Trait Empathy (Interpersonal Reactivity Index)

    A 28-item instrument using an A-E Likert (A = does not describe me well … E = describes me very well) that measures participants' trait empathic disposition. Four dimensions of trait empathy are used: fantasy scale, empathic concert, perspective taking, and personal distress.

    Measured: Baseline

  9. Patient Health

    A 2-item instrument using a 0-3 Likert (0 = not at all … 3 = nearly every day) that measures participants' perceived depression over the last 2-weeks.

    Measured: Baseline, 2-weeks

  10. Revised Self-Monitoring

    A 13-item instrument using a 1-5 Likert (1 = … 5 = ) to measure socioemotional sensitivity and responsiveness to the behavioral expressions of others. An example is "In conversations, the subject is sensitive to even the slightest change in the facial expression of the other person he/she is conversing with."

    Measured: Baseline, 2-weeks

  11. Self-Compassion

    A 12-item instrument using a 1-5 Likert (1 = almost never … 5 = almost always) to measure an individual's self-compassion. An example is "When I fail at something important to me I become consumed by feelings of inadequacy."

    Measured: Baseline, 2-weeks

  12. Inclusion of Self in Other

    A 7-item instrument using concentric circles (1 = no overlap … 7 = most overlap) to measure an individual's perceived relationship between self to other.

    Measured: Baseline, 2-weeks

Secondary outcomes (2)
  1. Patient resting state functional connectivity (RSFC)

    Pre-gathered RSFC will be used in mixed models to determine its predictive potential on rhythm production, social attention, and connectedness.

    Measured: From date of completion of collection of all primary outcome measures, assessed up to 24 months

  2. Perceptions of relationship quality between participants as determined by word frequency analysis of semi-structured interview data

    Semi-structured interviews between participants of the dyad-pair will be analyzed using qualitative data analysis software for word frequencies of subjective and objective perceptions of their relationship with one another.

    Measured: From date of completion of collection of all primary outcome measures, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start10 Jan 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control-treatment
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768996
Sponsor's protocol ID
23-40419
Other IDs
T32AG078115
Status last verified
Dec 2025
First submitted
5 Dec 2024
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spinosa V, Vitulli A, Logroscino G, Brattico E. A Review on Music Interventions for Frontotemporal Aphasia and a Proposal for Alternative Treatments. Biomedicines. 2022 Dec 29;11(1):84. doi: 10.3390/biomedicines11010084.

    PubMed 36672592
  • Clarke E, DeNora T, Vuoskoski J. Music, empathy and cultural understanding. Phys Life Rev. 2015 Dec;15:61-88. doi: 10.1016/j.plrev.2015.09.001. Epub 2015 Sep 7.

    PubMed 26419700
  • Hobeika L, Ghilain M, Schiaratura L, Lesaffre M, Puisieux F, Huvent-Grelle D, Samson S. The effect of the severity of neurocognitive disorders on emotional and motor responses to music. Ann N Y Acad Sci. 2022 Dec;1518(1):231-238. doi: 10.1111/nyas.14923. Epub 2022 Nov 2.

    PubMed 36321882
  • Hobeika L, Ghilain M, Schiaratura L, Lesaffre M, Huvent-Grelle D, Puisieux F, Samson S. Socio-emotional and motor engagement during musical activities in older adults with major neurocognitive impairment. Sci Rep. 2021 Jul 27;11(1):15291. doi: 10.1038/s41598-021-94686-4.

    PubMed 34315954
  • Kumfor F, Honan C, McDonald S, Hazelton JL, Hodges JR, Piguet O. Assessing the "social brain" in dementia: Applying TASIT-S. Cortex. 2017 Aug;93:166-177. doi: 10.1016/j.cortex.2017.05.022. Epub 2017 Jun 7.

    PubMed 28662418
  • Colverson A, Barsoum S, Cohen R, Williamson J. Rhythmic musical activities may strengthen connectivity between brain networks associated with aging-related deficits in timing and executive functions. Exp Gerontol. 2024 Feb;186:112354. doi: 10.1016/j.exger.2023.112354. Epub 2024 Jan 3.

    PubMed 38176601

Questions about this trial

What is this clinical trial studying?

A study testing Synchronous Rhythm Production and Solo Rhythm Production in people with Frontotemporal Dementia and Alzheimer Disease, 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 6 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 3 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 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?

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?

Social Attention (TASIT) (time frame: Baseline, 2-weeks). The study lists 12 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 NCT06768996, which also lists 6 linked publications.

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 3 Dec 2025.

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