Brain Stimulation + Methylphenidate for Dementia
(PRIME Trial)
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
KL
Krista Lanctot, PhD
Principal Investigator
Sunnybrook Research Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
MMSE score 10-28 inclusive
Clinically significant apathy
I have Alzheimer's disease or a combination of Alzheimer's and vascular disease.
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Exclusion Criteria
Failure to clear the TMS adult safety scale (e.g. unapproved pacemakers, metallic implants, history of epilepsy)
Any condition that in the opinion of the study physician, makes it medically unsafe for the patient to enroll in the trial
I am currently experiencing a major depressive episode.
See 3 more
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation
- Methylphenidate
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: iTBS onlyExperimental Treatment1 Intervention
iTBS only, no medication for apathy
Group II: Methylphenidate + iTBSExperimental Treatment2 Interventions
Participants are currently receiving methylphenidate and receive iTBS in this study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Trials
693
Recruited
1,569,000+
Alzheimer Society of Canada
Collaborator
Trials
10
Recruited
2,900+
Sunnybrook Research Institute
Collaborator
Trials
33
Recruited
216,000+
Brain Canada
Collaborator
Trials
22
Recruited
6,100+
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