Actively Recruiting
Methylphenidate Primed Intermittent Theta Burst Stimulation for Apathy in Neurocognitive Disorders
Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-12
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
A
Alzheimer Society of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combined treatment of methylphenidate and intermittent theta burst stimulation (iTBS), a non-invasive brain stimulation technique, to treat apathy in individuals with Alzheimer's disease or mixed Alzheimer's and vascular dementia. This Phase 2 study focuses on whether this combination can effectively reduce apathy symptoms compared to iTBS alone. Participants have clinically significant apathy and are on stable psychotropic medication doses before joining. The study includes two groups: one receiving both methylphenidate and iTBS, and the other receiving only iTBS without medication for apathy. Methylphenidate is given as a drug treatment, while iTBS is delivered using a device that applies repetitive transcranial magnetic stimulation to the brain. Participants are already on methylphenidate before enrollment, and the treatments are monitored throughout the study. Participants will have their apathy levels measured using the Neuropsychiatric Inventory-Apathy (NPI-A) score after two weeks. Researchers will monitor symptoms, medication stability, and safety, including screening for conditions like epilepsy or metal implants that affect brain stimulation safety. Care partners who spend significant time with participants will support adherence. The study is expected to continue until October 2027, with careful evaluation of apathy changes and participant well-being.
CONDITIONS
Brief Title
Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Alzheimer's disease or mixed Alzheimer's and vascular disease
- MMSE score between 10 and 28 inclusive
- Clinically significant apathy
- Stable dose of psychotropic medication
- Care partner spends at least 10 hours per week with the participant
You will not qualify if you...
- Current major depressive episode
- Clinically significant agitation, delusions, or hallucinations
- Taking dopaminergic agents other than methylphenidate
- Unable to pass the TMS adult safety scale (e.g., unapproved pacemakers, metallic implants, history of epilepsy)
- Central nervous system abnormalities other than Alzheimer's disease considered clinically significant or history of seizures
- Any condition making participation medically unsafe as judged by the study physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants receive intermittent theta burst stimulation (iTBS) with or without continuing methylphenidate to treat apathy in neurocognitive disorders.
Multiple visits during treatment period
Trial Site Locations
Total: 1 location
1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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