intermittent theta burst stimulation (iTBS): iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Methylphenidate (MPH): Participants will be on methylphenidate clinically prior to the trial
Study summary
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
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score — 2 weeks Assesses apathy total (frequency x severity) using the NPI-A based on scores provided by the care-partner through an interview with the assessor. Scores range from 0-12 with a higher score representing worse apathy.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Research Institute
Toronto
Ontario
Recruiting
More Sunnybrook Health Sciences Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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