RecruitingPhase 2NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

12 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria5

  • 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 Criteria6

  • 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

Interventions

DEVICEintermittent theta burst stimulation (iTBS)

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

DRUGMethylphenidate (MPH)

Participants will be on methylphenidate clinically prior to the trial


Locations(1)

Sunnybrook Research Institute

Toronto, Ontario, Canada

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NCT07279740


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