Levetiracetam for Persons at Risk for Alzheimer's Disease (ALEVIATE-2)

What is this Study about?

The goal of this study is to investigate whether very small doses of a drug called levetiracetam (LEV) may reduce abnormal brain signaling in the brain in individuals who are at an increased risk for developing Alzheimer's Disease. Only participants who show the abnormal brain signaling on a functional MRI (fMRI) scan of the brain will be enrolled in the study. Enrolled participants will receive 4 weeks of treatment with LEV and 4 weeks of treatment with placebo (a sugar pill). The study involves cognitive testing, genetic testing, bloodwork, ECGs, questionnaires and several brain imaging scans.

What Will Happen in This Study?

Participants are in the study for 6-7 months. Most of the visits occur in person at Toronto Western Hospital.

The first 3 visits (1-4h) are to confirm eligibility. They include cognitive tests, review of medical history/medications, brain MRI, bloodwork, physical exam, and ECG.

Eligible participants go on to Baseline, Week 4, Week 8 and Week 12 visits, amyloid PET visit, and follow-up phonecall. These visits will involve medication dispensing, MRI, EEG-MEG, ECG, bloodwork, blood for APOE genotyping and AD biomarkers, cognitive tests, physical exams, review of medications and adverse events. Visit duration: Baseline 3-4h; Week 4/8/12 7-8h; PET 2h.

Who is Eligible to Participate in this Study?

• Are between 55-85 years of age

• Have a parent or sibling with Alzheimer’s disease or with dementia that may be due to Alzheimer’s disease (even if not diagnosed as such)

• Feel your memory is getting worse

• Get normal scores on tests of thinking and memory (will be done as part of the study)

• Are able to undergo brain MRI scans

• Have a study partner (friend or family member) willing to answer questionnaires about you

• Show increased brain signaling during the screening fMRI scan (Note: We anticipate that most people who sign up for the study will NOT show the increased brain activity levels required to qualify for the study treatment)

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