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NCT Number: NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

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

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Key information

Conditions

Alzheimer s Disease Alzheimer Dementia Alzheimer Dementia (AD) Alzheimer Disease Apathy Apathy in Dementia Brain Diseases Central Nervous System Diseases Dementia Lethargy Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

[email protected]

416-480-6100 ext. 63185

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent theta burst stimulation (iTBS)

Device

iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.

Methylphenidate (MPH)

Drug

Participants will be on methylphenidate clinically prior to the trial

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Alzheimer Society of Canada
  • Brain Canada
  • Sunnybrook Research Institute

Registry information

Official study title

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders

Acronym: PRIME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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