Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia (PRIME)

Sunnybrook Health Sciences Centre

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Dementia; Apathy in Dementia; Apathy; Alzheimer Disease; Alzheimer s Disease; Alzheimer Dementia (AD)

Treatments: Device: intermittent theta burst stimulation (iTBS); Drug: Methylphenidate (MPH)

Study type: Interventional

Funder types: Other

Identifiers

NCT07279740

SUN-6831

Details and patient eligibility

About

This study evaluates whether the combined treatment of methylphenidate and non-invasive brain stimulation, called intermittent theta burst stimulation, can effectively treat apathy in individuals with Alzheimer's disease or mixed AD/vascular dementia

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alzheimer's disease or mixed Alzheimer's disease and vascular disease
• MMSE score 10-28 inclusive
• Clinically significant apathy
• Stable dose of psychotropic medication
• Care partner must spend at least 10hrs/week with the participant

Exclusion criteria

• Major Depressive Episode
• Clinically significant agitation, delusions, hallucinations
• Currently talking a dopaminergic agent other than methylphenidate
• Failure to clear the TMS adult safety scale (e.g. unapproved pacemakers, metallic implants, history of epilepsy)
• Central nervous system abnormalities (other than Alzheimer's disease) deemed clinically significant by study physician or seizures
• Any condition that in the opinion of the study physician, makes it medically unsafe for the patient to enroll in the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Methylphenidate + iTBS

Experimental group

Description:

Participants are currently receiving methylphenidate and receive iTBS in this study.

Treatment:

Drug: Methylphenidate (MPH)

Device: intermittent theta burst stimulation (iTBS)

iTBS only

Experimental group

Description:

iTBS only, no medication for apathy

Treatment:

Device: intermittent theta burst stimulation (iTBS)