RecruitingPhase 2NCT07477431

Levetiracetam for Persons at Risk for Alzheimer's Disease

A Proof-of-Concept, Multicentre, Phase IIb, Randomized Double-Blind Crossover Trial of Levetiracetam vs Placebo for Hippocampal Hyperactivity in Cognitively Normal Individuals at Risk for Alzheimer's Disease


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

40 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate whether very small doses of a drug called levetiracetam (LEV) may reduce abnormal brain signaling in individuals who are at an increased risk for developing Alzheimer's Disease (AD). The study is looking for individuals who have a parent or sibling with Alzheimer's disease (dementia), and who have memory complaints but are currently performing within normal limits on cognitive testing. During the screening period, a functional MRI (fMRI) scan of the brain will identify those participants who have the abnormal brain signaling that the study is looking to treat. All participants will receive 4 weeks of treatment with LEV and 4 weeks of treatment with placebo (a sugar pill), but it will not be known what order they will receive them in. Participants will undergo cognitive testing, genetic testing, and several brain imaging scans as part of the study. This is a pilot study, meaning that it is being carried out for the first time in a small number of participants. If the results show that treatment with LEV appears to be more beneficial than placebo in normalizing brain signaling, a larger study may follow. This study is only being carried out in Toronto, Canada.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called levetiracetam — currently used for epilepsy — can help protect memory and thinking skills in people who are at higher risk of developing Alzheimer's disease but do not yet have dementia. Researchers believe this drug may calm overactive brain activity that happens early in Alzheimer's. **You may be eligible if...** - You have noticed some changes in your memory or thinking (but your cognitive tests are still within normal range) - A close family member (parent, sibling, or child) has had Alzheimer's disease or a similar dementia - You are post-menopausal or have had a procedure that prevents pregnancy (if female) - You are fluent in English and have a family member or friend who can also participate **You may NOT be eligible if...** - Your cognitive tests show actual impairment beyond normal limits - You are not post-menopausal or have not had a sterilization procedure (if female) - You do not have someone in your life with weekly contact who can complete study questionnaires - You do not speak English well enough for cognitive testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLevetiracetam (LEV)

Levetiracetam 125mg capsules BID for 28-35 days

OTHERPlacebo

Placebo capsules BID for 28-35 days


Locations(2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07477431