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Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

RecruitingPhase 2Ages any - anyAllSunnybrook Health Sciences Centre
NCT07279740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • intermittent theta burst stimulation (iTBS)
  • Methylphenidate (MPH)
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Where

1 site
Sunnybrook Research Institute
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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