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Music, Social Attention, and Dementia

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Active, not recruiting

Conditions

Alzheimer Disease
Frontotemporal Dementia

Treatments

Behavioral: Solo Rhythm Production
Behavioral: Synchronous Rhythm Production

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06768996
23-40419
T32AG078115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

55 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion (patients)

  • 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.

Inclusion (caregivers)

  • 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.

Exclusion (patients)

  • 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.

  • 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

Exclusion (Caregivers)

  • 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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Solo Rhythm Production
Active Comparator group
Description:
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.
Treatment:
Behavioral: Solo Rhythm Production
Synchronous Rhythm Production
Experimental group
Description:
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.
Treatment:
Behavioral: Synchronous Rhythm Production

Trial contacts and locations

1

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Central trial contact

Bailey McEachen, MTM; Aaron Colverson, PhD

Data sourced from clinicaltrials.gov

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