Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia
Recruiting · NCT07279740 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
Methylphenidate (MPH)intermittent theta burst stimulation (iTBS)
What this trial is about
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 can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Sunnybrook Research Institute - Toronto, Ontario, Canada