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New treatment option for Hippocampal Hyperactivation
Official title Levetiracetam for Persons at Risk for Alzheimer's Disease
ClinicalTrials.gov ID: NCT07477431
What this study is testing
What is Levetiracetam (LEV)?
Levetiracetam (LEV) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hippocampal hyperactivation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- 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...
- Female participants must be post-menopausal (amenorrheic for at least 12 consecutive months without other known or suspected cause) or surgically...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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:
- 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.
- 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...
- Hippocampal hyperactivation, defined as activation \>1.5 SD above the mean, during the pattern separation task (PST) on BOLD fMRI.
What rules you out
- 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
- 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:
- 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
- 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
- Methotrexate
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.