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Levetiracetam for Persons at Risk for Alzheimer's Disease

Study acronym: ALEVIATE-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Jan 2027 → Dec 2027
See other at-risk trials from Sunnybrook Health Sciences Centre

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jan 2027 to Dec 2027v2 Show 4 more changesShow less
    • Study completion pushed from Feb 2027 to Feb 2028
    • Eligibility criteria shortened, about 124 words
    • Study description shortened, about 43 words
    • Site contacts updated at 1 of 2 sites
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to investigate whether very small doses of a drug called levetiracetam (LEV) may reduce elevated brain signaling in individuals who are at an increased risk for developing Alzheimer's Disease (AD). The study is looking for people who are currently performing within normal limits on memory testing but who have one or more of the following risk factors for developing AD: 1. People who feel like their memory is getting worse and who have a parent or sibling with Alzheimer's disease (dementia) 2. People with two copies of the APOE E4 gene 3. People who have tested positive for a biomarker of AD (e.g., blood p-tau test, brain amyloid PET scan) During the screening period, a functional MRI (fMRI) scan of the brain will identify those participants who have the increased 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.
Trial Details
NCT Number NCT07477431
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: University Health Network, Toronto, Weston Brain Institute
Conditions
(from sponsor)
Hippocampal Hyperactivation, Prodromal Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov