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RECRUITING
NCT07477431
PHASE2

Levetiracetam for Persons at Risk for Alzheimer's Disease

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-10-23

Completion Date

2027-02

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

Levetiracetam (LEV)

Levetiracetam 125mg capsules BID for 28-35 days

OTHER

Placebo

Placebo capsules BID for 28-35 days

Locations (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada