Actively Recruiting

Phase 2
All Genders
NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-12

12

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

A

Alzheimer Society of Canada

Collaborating Sponsor

AI-Summary

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

CONDITIONS

Official Title

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Alzheimer's disease or mixed Alzheimer's and vascular disease
  • Mini-Mental State Examination (MMSE) score between 10 and 28 inclusive
  • Presence of clinically significant apathy
  • Stable dose of psychotropic medication
  • Care partner spends at least 10 hours per week with the participant
Not Eligible

You will not qualify if you...

  • Current major depressive episode
  • Clinically significant agitation, delusions, or hallucinations
  • Taking dopaminergic agents other than methylphenidate
  • Not passing the TMS adult safety scale (e.g., having unapproved pacemakers, metallic implants, or history of epilepsy)
  • Central nervous system abnormalities other than Alzheimer's disease considered clinically significant
  • History of seizures
  • Any condition making participation medically unsafe according to the study physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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