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

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of brain stimulation (TMS — a non-invasive device that uses magnetic pulses to stimulate brain activity) and methylphenidate (a medication that may boost motivation) to treat apathy — a loss of interest and motivation — in people with Alzheimer's disease or mixed dementia. **You may be eligible if...** - You have been diagnosed with Alzheimer's disease or mixed Alzheimer's and vascular dementia - Your cognitive test score (MMSE) is between 10 and 28 - You have clinically significant apathy (low motivation and engagement) - Your psychotropic medications have been stable - A care partner spends at least 10 hours per week with you **You may NOT be eligible if...** - You are currently experiencing a major depressive episode - You have significant agitation, delusions, or hallucinations - You are taking other dopaminergic medications (like levodopa) besides methylphenidate - You have a pacemaker, metallic implants, or a history of epilepsy (which would make TMS unsafe) - You have other significant neurological conditions beyond dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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