Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia (PRIME)

December 11, 2025 updated by: Sunnybrook Health Sciences Centre

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate + iTBS
Participants are currently receiving methylphenidate and receive iTBS in this study.
Device: intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Drug: Methylphenidate (MPH)
Participants will be on methylphenidate clinically prior to the trial
Experimental: iTBS only
iTBS only, no medication for apathy
Device: intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score
Time Frame: 2 weeks
Assesses apathy total (frequency x severity) using the NPI-A based on scores provided by the care-partner through an interview with the assessor. Scores range from 0-12 with a higher score representing worse apathy.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Sunnybrook Research Institute
Alzheimer Society of Canada
Brain Canada

Investigators

  • Principal Investigator: Krista Lanctôt, PhD, Sunnybrook Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN-6831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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