Levetiracetam for overactive brain signaling in people at risk for Alzheimer's disease
Tests levetiracetam against placebo in memory-normal people at risk for Alzheimer's.
Plain-language title generated from the registry record
Registry title: Levetiracetam for Persons at Risk for Alzheimer's Disease
Key facts
- Where
- Toronto, CanadaSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 55 to 85 with normal memory test results who have a higher risk of Alzheimer's disease and overactive brain signaling in the hippocampus on a brain scan.
- Age
- 55 to 85 years
- Sex
- All sexes. Women must be post-menopausal or surgically sterile.
- Disease stage
- Normal results on the Montreal Cognitive Assessment (MoCA) memory test. Higher risk of Alzheimer's disease, shown by one or more of: memory complaints plus a parent, sibling or child with Alzheimer's or dementia; a positive amyloid or tau test; or two copies of the APOE e4 gene. A brain scan (BOLD fMRI) must show hippocampal hyperactivation, meaning activation >1.5 MAD above the median.
- Earlier treatment
- Cannot be taking anticonvulsant medicines (unless for something other than seizures) or methotrexate.
- Biomarker or test result
- Amyloid or tau positive, or two copies of APOE e4 (e4/e4), for at least one risk route. Hippocampal hyperactivation on fMRI is required.
Main reasons for not taking part
- Any type of cognitive impairment, or significant brain disease such as epilepsy, stroke or Parkinson's disease
- Seizures or transient ischemic attacks within 12 months of screening
- Significant or unstable psychiatric illness, including recent suicidal thoughts or behavior
- Drug or alcohol abuse or dependence within 2 years before screening
- Anything that rules out MRI or MEG scans, such as a pacemaker or metal implants
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Source: NCT07477431, who can take part
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
- Toronto Western HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT07477431
- Record updated
- 29 July 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: Willing to undergo all study procedures and has signed the informed consent form; Within normal limits on the Montreal Cognitive Assessment (MoCA) at Screening; Age 55-85; 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; Increased risk of Alzheimer's disease, as indicated by one or more of the following:; Participant has subjective cognitive complaints AND a family history of Alzheimer's disease (or of dementia suggestive of possible or probable Alzheimer's disease) in a first-degree relative; and/or; Participant is known to be amyloid or tau positive; and/or; Participant is known to be an APOE e4/e4 homozygote; Hippocampal hyperactivation, defined as activation >1.5 MAD above the median, during the pattern separation task (PST) on BOLD fMRI.
Exclusion: Any of the following findings on a current (completed during screening) or previous brain MRI/CT scan:; Severe white matter disease (Fazekas score66 = 3); Stroke involving a major vascular territory; Subcortical lacunar infarcts >1.5cm in diameter; Encephalomalacia; Vascular malformations that are at high risk of hemorrhage; Infective lesions; Space-occupying lesions; 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:; Anticonvulsant medications (unless taken for a different indication than seizures); Methotrexate; History of hypersensitivity to levetiracetam or any other ingredients in the study drug or placebo; Significant neurological disease, including but not limited to:; Any type of cognitive impairment; History of transient ischemic attacks within 12 months of Screening; History of seizures within 12 months of Screening; Epilepsy; Parkinson's disease; Stroke (aside from subcortical lacunar infarcts); Multiple sclerosis; Huntington's disease; Normal pressure hydrocephalus; Brain tumour (aside from benign tumours without mass effect, which are to be judged on a case-by-case basis); Subdural hematoma; History of traumatic brain injury with persistent neurological deficits; Known structural brain abnormalities; Significant or unstable psychiatric disease, including but not limited to:; Schizophrenia; Bipolar disorder; Major depression which is not controlled in the opinion of the investigator; Score ≥10 on the Geriatric Depression Scale (GDS) at Screening; 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; Answered "yes" to any of the suicide-related behaviours within the last 3 months on the Suicidal Behavior portion of the C-SSRS; Hospitalized or treated for suicidal behavior within 5 years of Screening; 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; 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:; History of malignancy within 3 years of screening (except of basal or squamous cell carcinoma of the skin); Moderate-severe chronic kidney disease, chronic obstructive pulmonary disease, or congestive heart failure; eGFR <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.