Can a tiny dose of an epilepsy drug slow Alzheimer's before symptoms start?
NCT ID NCT07477431
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests whether a very low dose of levetiracetam, a drug used for epilepsy, can reduce abnormal overactivity in a key memory area of the brain. It includes 40 people who have a parent or sibling with Alzheimer's and have memory concerns but still score normally on thinking tests. Participants will take the drug or a placebo for 4 weeks each, without knowing the order, and undergo brain scans and memory tasks to see if the drug helps normalize brain signals.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. 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 2. Participant is known to be amyloid or tau positive; and/or 3. 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 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 * 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 (unless taken for a different indication than seizures) 2. Methotrexate * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Toronto Western Hospital
RECRUITINGToronto, Ontario, M5T 2S8, Canada
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