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Recruiting NCT07279740

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Phase II Interventional Alzheimer s Disease Alzheimer Dementia (AD) Alzheimer Dementia Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intermittent theta burst stimulation (iTBS), Methylphenidate (MPH).
Who it may be relevant to
Registry conditions: Alzheimer s Disease, Alzheimer Dementia (AD), Alzheimer Dementia, Alzheimer Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders

Overview

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

Interventions

  • 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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Sunnybrook Research Institute — Toronto

Identifiers

NCT: NCT07279740 · SUN-6831

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗