Trial0

Clinical trial · NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

RecruitingPhase 2

Sponsor: Sunnybrook Health Sciences Centre

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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

Interventions

  • intermittent theta burst stimulation (iTBS) · DEVICE

    iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.

  • Methylphenidate (MPH) · DRUG

    Participants will be on methylphenidate clinically prior to the trial

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

  • Sunnybrook Research Institute, Toronto, Ontario · Recruiting

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2025-12-12.