Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Levetiracetam for Persons at Risk for Alzheimer's Disease (NCT07477431) is a Phase 2 interventional studying Hippocampal Hyperactivation and Prodromal Alzheimer Disease, sponsored by Sunnybrook Health Sciences Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hippocampal Hyperactivation and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Willing to undergo all study procedures and has signed the willing to sign a consent form form. - Has a friend or family member who has weekly contact with the participant and is willing to sign the study partner willing to sign a consent form 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 the exceptions noted below: 1. A borderline score on the executive domain may be acceptable if in the opinion of the investigator it is solely attributable to the participant having ADHD. 2. A borderline score on the language domain may be acceptable if in the opinion of the investigator it is solely attributable to English not being the participant's primary 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. Who Should NOT Join This Trial: - History of hypersensitivity to levetiracetam or any other ingredients in the study drug or placebo. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 the exceptions noted below: 1. A borderline score on the executive domain may be acceptable if in the opinion of the investigator it is solely attributable to the participant having ADHD. 2. A borderline score on the language domain may be acceptable if in the opinion of the investigator it is solely attributable to English not being the participant's primary 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. Exclusion Criteria: * History of hypersensitivity to levetiracetam or any other ingredients in the study drug or placebo. * Significant neurological disease, including but not limited to: 1. Any type of cognitive impairment 2. History of transient ischemic attacks within 12 months of Screening 3. History of seizures within 12 months of Screening 4. Epilepsy 5. Parkinson's disease 6. Stroke (aside from subcortical lacunar infarcts) 7. Multiple sclerosis 8. Huntington's disease 9. Normal pressure hydrocephalus 10. Brain tumour (aside from benign tumours without mass effect, which are to be judged on a case-by-case basis) 11. Subdural hematoma 12. History of traumatic brain injury with persistent neurological deficits 13. Known structural brain abnormalities * Significant or unstable psychiatric disease, including but not limited to: 1. Schizophrenia 2. Bipolar disorder 3. Major depression which is not controlled in the opinion of the investigator 4. Score ≥10 on the Geriatric Depression Scale (GDS) at Screening 5. Presence of active suicidal ideation within the last 3 months as indicated by "yes" response to Question 4 or 5 on the Suicidal Ideation portion of the C-SSRS at Screening 6. Answered "yes" to any of the suicide-related behaviours within the last 3 months on the Suicidal Behavior portion of the C-SSRS 7. Hospitalized or treated for suicidal behavior within 5 years of Screening 8. Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol in the opinion of the investigator 9. Score ≥9 on the Mild Behavioural Impairment Checklist (MBI-C) at Screening * Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening). * Significant or unstable systemic illness or medical condition that would in the investigator's judgment make the participant unsuitable for inclusion in the study, including but not limited to: 1. History of malignancy within 3 years of screening (except of basal or squamous cell carcinoma of the skin) 2. Moderate-severe chronic kidney disease, chronic obstructive pulmonary disease, or congestive heart failure * Any of the following findings on a current (completed during screening) or previous brain MRI/CT scan: 1. Severe white matter disease (Fazekas score66 = 3) 2. Stroke involving a major vascular territory 3. Subcortical lacunar infarcts \>1.5cm in diameter 4. Encephalomalacia 5. Vascular malformations that are at high risk of hemorrhage 6. Infective lesions 7. Space-occupying lesions 8. Any other abnormality that would in the opinion of the investigator make the participant unsuitable for participation in the study * Any contraindications to MRI or MEG (e.g., pacemaker, ferromagnetic metal implants, claustrophobia). * Treatment with the following medications at time of screening or while in the study: 1. Anticonvulsant medications 2. Methotrexate 3. Anticholinergic agents and medications with anticholinergic properties * Creatinine clearance \<50ml/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 would in the opinion of the investigator make the participant unsuitable for inclusion in the study.

Treatments Being Tested

DRUG

Levetiracetam (LEV)

Levetiracetam 125mg capsules BID for 28-35 days

OTHER

Placebo

Placebo capsules BID for 28-35 days

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07477431), the sponsor (Sunnybrook Health Sciences Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07477431 clinical trial studying?

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 l… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07477431?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07477431?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07477431. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07477431. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.