Actively Recruiting
Levetiracetam for Persons at Risk for Alzheimer's Disease
Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-17
40
Participants Needed
2
Research Sites
66 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Levetiracetam for Persons at Risk for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to undergo all study procedures and has signed the informed consent form.
- Has a friend or family member who has weekly contact with the participant and is willing to sign the study partner informed consent and complete study questionnaires.
- Female participants must be post-menopausal (amenorrheic for at least 12 consecutive months without other known or suspected cause) or surgically sterile (bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy).
- Sufficiently fluent in English to undergo cognitive testing, per investigator judgment.
- Presence of subjective cognitive complaints, indicated by score >7 on MyCog portion of the Subjective Cognitive Decline Questionnaire (SCD-Q) at Screening.
- Family history of Alzheimer's disease or of dementia suggestive of possible or probable Alzheimer's disease in a first-degree relative.
- Head circumference <60cm.
- Within normal limits on all domains of the Toronto Cognitive Assessment (TorCA) at Screening or in the previous 6 months, with exceptions for borderline scores attributable to ADHD or non-primary English language.
- Known to be within normal limits on the Montreal Cognitive Assessment (MoCA), Cogniciti Brain Health Assessment (BHA), or Toronto Cognitive Assessment (TorCA) in the previous 6 months, or within normal limits on the MoCA at Screening.
- Hippocampal hyperactivation, defined as activation >1.5 SD above the mean, during the pattern separation task (PST) on BOLD fMRI.
You will not qualify if you...
- History of hypersensitivity to levetiracetam or any other ingredients in the study drug or placebo.
- Significant neurological disease including any cognitive impairment, recent transient ischemic attacks, seizures or epilepsy, Parkinson's disease, stroke (except subcortical lacunar infarcts), multiple sclerosis, Huntington's disease, normal pressure hydrocephalus, brain tumour (except benign without mass effect), subdural hematoma, traumatic brain injury with deficits, or structural brain abnormalities.
- Significant or unstable psychiatric disease including schizophrenia, bipolar disorder, uncontrolled major depression, high Geriatric Depression Scale score, recent active suicidal ideation or behavior, recent psychotic features or agitation, or high Mild Behavioural Impairment Checklist score.
- Known or suspected drug or alcohol abuse or dependence within 2 years before screening.
- Significant or unstable systemic illness including recent malignancy (except certain skin cancers), moderate-severe kidney disease, chronic obstructive pulmonary disease, or congestive heart failure.
- Certain findings on MRI/CT scans including severe white matter disease, major stroke, large lacunar infarcts, encephalomalacia, high-risk vascular malformations, infective lesions, space-occupying lesions, or other abnormalities judged unsuitable.
- Contraindications to MRI or MEG such as pacemaker, ferromagnetic implants, or claustrophobia.
- Current treatment with anticonvulsants, methotrexate, anticholinergic agents, or medications with anticholinergic properties.
- Creatinine clearance <50 ml/min/1.73m2 on screening bloodwork.
- QTc interval >470 msec (males) or >480 msec (females) on screening ECG.
- Clinically significant abnormal results on screening bloodwork that make the participant unsuitable in the investigator's opinion.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
A
ALEVIATE-2 Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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