NCT06768996 · ACTIVE NOT RECRUITING

Music, Social Attention, and Dementia

This study is testing whether rhythmic music activities — drumming or clapping together versus alone — can improve social connection and attention between people living with mild to moderate behavioral FTD or Alzheimer's disease and their caregivers. Researchers will also look at related brain network activity. This is an exploratory study, meaning it is early-stage and focused on gathering initial data, not proving a treatment works.

Eligibility 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-12-03

View full record on ClinicalTrials.gov

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