Recruiting
Phase 2

Methylphenidate & TBS

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07279740

Conditions

Alzheimer s Disease

Alzheimer Dementia (AD)

Alzheimer Dementia

Alzheimer Disease

Apathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

intermittent theta burst stimulation (iTBS)

Methylphenidate (MPH)

Study Details

Brief summary:

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

Conditions

Alzheimer s Disease

Alzheimer Dementia (AD)

Alzheimer Dementia

Alzheimer Disease

Apathy

Study ID

NCT07279740

Start date

Jan, 2026

Status verified date

Dec, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methylphenidate + iTBS

Participants are currently receiving methylphenidate and receive iTBS in this study.

experimental: iTBS only

iTBS only, no medication for apathy

Interventions

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

Primary outcome measure

  • Change in Neuropsychiatric Inventory-Apathy (NPI-A) score [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

416-480-6100memoryresearch@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • apathy
  • dementia
  • Alzheimer's disease
  • methylphenidate
  • rTMS
  • iTBS
  • repetitive transcranial magnetic stimulation
  • intermittent theta burst stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-12-12.