Brain stimulation plus methylphenidate for apathy in Alzheimer's
Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders
This trial will test whether combining short sessions of noninvasive brain stimulation (intermittent theta burst) with methylphenidate can reduce apathy in people with Alzheimer's disease or mixed Alzheimer's/vascular dementia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07279740 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives people with Alzheimer's disease or mixed Alzheimer/vascular dementia who have clinically significant apathy a course of intermittent theta burst stimulation (iTBS) alongside the stimulant medication methylphenidate. Eligible participants have an MMSE score of 10–28, must be on stable psychotropic medications, and require a care partner who spends at least 10 hours per week with them. Key exclusions include current major depressive episode, clinically significant psychosis or agitation, seizure history or incompatible implants, and current use of other dopaminergic agents. All visits occur at Sunnybrook Research Institute in Toronto where safety monitoring and standardized measures of apathy will be used.
Who should consider this trial
Good fit: Ideal candidates are people with Alzheimer's disease or mixed Alzheimer/vascular dementia who have clinically significant apathy, an MMSE of 10–28, a nearby care partner who spends at least 10 hours weekly with them, and no medical contraindications to brain stimulation or stimulants.
Not a fit: Patients with a major depressive episode, active psychosis or agitation, seizure disorders, incompatible implants, or those already taking other dopaminergic medications are unlikely to be eligible or to benefit from this combined treatment.
Why it matters
Potential benefit: If successful, the combination could provide a new, noninvasive option to reduce apathy and improve engagement and daily function in people with Alzheimer's.
How similar studies have performed: Previous trials have shown modest benefits of methylphenidate for apathy in Alzheimer's and early, mixed evidence for noninvasive brain stimulation, while the combined approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Krista Lanctot, PhD — Sunnybrook Research Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.