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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
REACT Trial 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.Check my eligibility
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.See study design
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.
REACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neuropsychiatric Inventory-apathy
REACT 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
656 Previous Clinical Trials
1,551,300 Total Patients Enrolled
9 Trials studying Dementia
2,976 Patients Enrolled for Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using an amphetamine product.I experience severe restlessness, false beliefs, or see things that aren't there.I am currently experiencing a major depressive episode.I have a care partner who is with me for at least 10 hours a week.I have CNS abnormalities, Tourette's, or motor tics.I've been on a stable dose of medication for over 4 weeks that could affect my thinking or behavior.I have been diagnosed with Alzheimer's disease or a mix of Alzheimer's and vascular disease.I cannot have rTMS due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: rTMS + methylphenidate
- Group 2: rTMS only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients currently being enrolled in this research project?
"Yes, the information on clinicaltrials.gov says that this clinical trial is actively recruiting candidates. The trial was originally posted on 10/1/2022 and was last edited on 9/29/2022. The trial is searching for 8 patients across 1 locations"
Answered by AI
How many people total will be enrolled in this clinical trial?
"That is correct, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. Originally posted on October 1st, 2020, this study aims to enroll 8 individuals from a single site."
Answered by AI
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