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Non-invasive Brain Stimulation

rTMS + Methylphenidate for Alzheimer's Disease (REACT Trial)

N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

This trial will investigate whether rTMS can improve apathy in Alzheimer's patients, with and without methylphenidate.

Who is the study for?
This trial is for individuals with Alzheimer's or mixed Alzheimer's/vascular disease who have shown signs of apathy for at least 4 weeks. They must have a care partner available and be on stable medication doses that could affect cognition or behavior. People with major depression, agitation, delusions, hallucinations, medical issues preventing rTMS use, amphetamine use, CNS abnormalities, Tourette's syndrome or motor tics can't participate.
What is being tested?
The study is testing if rTMS can help reduce apathy in people with Alzheimer’s when they are already taking methylphenidate (a stimulant) and in those not on any medication for apathy. It aims to see if stimulating the brain non-invasively can improve interest and enthusiasm.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache or lightheadedness. Methylphenidate might lead to increased blood pressure and heart rate, insomnia, loss of appetite, anxiety and potential addiction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neuropsychiatric Inventory-apathy

Trial Design

2Treatment groups
Experimental Treatment
Group I: rTMS onlyExperimental Treatment1 Intervention
repetitive transcranial magnetic stimulation (rTMS) only
Group II: rTMS + methylphenidateExperimental Treatment2 Interventions
repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840
methylphenidate
2010
Completed Phase 4
~780

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
671 Previous Clinical Trials
1,564,627 Total Patients Enrolled
10 Trials studying Dementia
3,476 Patients Enrolled for Dementia

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05561205 — N/A
Dementia Research Study Groups: rTMS + methylphenidate, rTMS only
Dementia Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT05561205 — N/A
rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05561205 — N/A
~1 spots leftby Dec 2024