Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia
NCT ID: NCT07279740
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2026-01-31
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
SINGLE
Study Groups
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Methylphenidate + iTBS
Participants are currently receiving methylphenidate and receive iTBS in this study.
intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Methylphenidate (MPH)
Participants will be on methylphenidate clinically prior to the trial
iTBS only
iTBS only, no medication for apathy
intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Interventions
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intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Methylphenidate (MPH)
Participants will be on methylphenidate clinically prior to the trial
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Alzheimer Society of Canada
OTHER
Sunnybrook Research Institute
OTHER
Brain Canada
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Krista Lanctot, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Research Institute
Locations
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Sunnybrook Research Institute
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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SUN-6831
Identifier Type: -
Identifier Source: org_study_id
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