Levetiracetam for Alzheimer's Disease Risk

(ALEVIATE-2 Trial)

Recruiting at 1 trial location

Overseen By ALEVIATE-2 Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anticonvulsants, Methotrexate, Anticholinergics

Disqualifiers: Cognitive impairment, Epilepsy, Schizophrenia, Bipolar, Major depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 23

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Sandra E. Black, MD, FRCP(C)

Principal Investigator

Sunnybrook Health Sciences Centre, University of Toronto

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

* 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.

I am a woman who is post-menopausal or surgically sterile.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 visits

3 visits (in-person)

Treatment Phase I

Participants receive either LEV or placebo for 4 weeks

4 weeks

Visits at Week 0 and Week 4

Treatment Phase II

Participants crossover to receive the alternate treatment (LEV or placebo) for 4 weeks

4 weeks

Visits at Week 8 and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visits at Week 12 and Week 16

What Are the Treatments Tested in This Trial?

Interventions

• Levetiracetam

How Is the Trial Designed?

Group I: Arm 2: Placebo then Drug Experimental Treatment 2 Interventions

Participants randomized to Arm 2 will receive placebo in Treatment Phase I and LEV in Treatment Phase II.

Group II: Arm 1: Drug then Placebo Experimental Treatment 2 Interventions

Participants randomized to Arm 1 will receive LEV in Treatment Phase I and placebo in Treatment Phase II.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Weston Brain Institute

Collaborator

Trials

13

Recruited

990+