Brain stimulation plus methylphenidate for apathy in Alzheimer's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Sunnybrook Research Institute
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Krista Lanctot, PhD — Sunnybrook Research Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.