Exploring the effects of music on social attention in dementia patients

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

This study is testing if making music together can help people with mild to moderate dementia and their caregivers feel more connected and engaged with each other.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 55 Years to 89 Years
• Sex: All
• Sponsor: University of California, San Francisco (other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06768996 on ClinicalTrials.gov

What this trial studies

This exploratory study investigates whether rhythmic musical activities can enhance social attention and connectedness in individuals with mild to moderate behavioral variant Frontotemporal Dementia (bvFTD) and Alzheimer's Disease (AD), along with their caregivers. Participants will engage in either synchronous rhythm production or solo rhythm activities, with evaluations conducted before and after the intervention. Additionally, the study will analyze brain connectivity through structural and functional MRI to explore relationships between rhythm production and social engagement.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 55 and older with a diagnosis of bvFTD or those aged 70 and older with Alzheimer's Disease.

Not a fit: Patients with normal cognitive functioning or those living with other forms of dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve social interactions and emotional well-being for patients with dementia and their caregivers.

How similar studies have performed: While the approach of using music therapy in dementia care is gaining interest, this specific study's focus on rhythmic activities and brain connectivity is relatively novel.

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

Where this trial is running

San Francisco, California

• Sandler Neurosciences Center — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Aaron Colverson, PhD — University of California, San Francisco
• Study coordinator: Aaron Colverson, PhD

Conditions: Frontotemporal Dementia, Alzheimer Disease