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Recruiting Phase 2 NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Trial Parameters

Condition Alzheimer s Disease
Sponsor Sunnybrook Health Sciences Centre
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 12
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2026-01
Completion 2027-10-01
Interventions
intermittent theta burst stimulation (iTBS)Methylphenidate (MPH)

Brief 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 Criteria

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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