rTMS + Methylphenidate for Alzheimer's Disease

(REACT Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Amphetamines

Disqualifiers: Depression, Agitation, Delusions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

Apathy is a common, early, and disabling symptom in dementias such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in AD in individuals receiving methylphenidate and individuals not receiving medication for apathy.

Eligibility Criteria

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.

Inclusion Criteria

Patients experiencing apathy for at least 4 weeks

I have a care partner who is with me for at least 10 hours a week.

I've been on a stable dose of medication for over 4 weeks that could affect my thinking or behavior.

Exclusion Criteria

Current participation in another clinical trial

I am currently using an amphetamine product.

I experience severe restlessness, false beliefs, or see things that aren't there.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) with or without methylphenidate

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Methylphenidate
• rTMS

Trial Overview 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.

Participant Groups

Group I: rTMS only Experimental Treatment 1 Intervention

repetitive transcranial magnetic stimulation (rTMS) only

Group II: rTMS + methylphenidate Experimental Treatment 2 Interventions

repetitive transcranial magnetic stimulation (rTMS) and methylphenidate

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+