Levetiracetam for Alzheimer's Disease Risk
(ALEVIATE-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether tiny doses of levetiracetam can reduce unusual brain activity in individuals at risk for Alzheimer's disease. It targets those with memory complaints who have a parent or sibling with Alzheimer's but still perform well on memory tests. Participants will receive both the drug and a placebo (a sugar pill) in different sequences to determine which is more effective. Individuals with a family history of Alzheimer's and memory concerns might find this Toronto-based trial suitable. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important research.
Do I need to stop my current medications for the trial?
You may need to stop taking certain medications, such as anticonvulsants, methotrexate, and anticholinergic agents, as they are not allowed during the study. It's best to discuss your current medications with the study team to see if any changes are needed.
Is there any evidence suggesting that levetiracetam is likely to be safe for humans?
Research has shown that levetiracetam is generally safe for people with Alzheimer's disease. One study found that participants experienced no significant negative effects from using this drug. Another study confirmed that Alzheimer's patients without a history of seizures tolerated levetiracetam well. These findings suggest that the medication is safe for humans, with reports showing no major side effects. Overall, the evidence indicates that levetiracetam is a safe option for people with Alzheimer's disease.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Levetiracetam is unique because, unlike most treatments for Alzheimer's disease that focus on symptom management, it targets the underlying risk factors associated with the disease. Standard treatments like cholinesterase inhibitors and memantine primarily address memory and cognitive symptoms. In contrast, levetiracetam, traditionally used as an anti-seizure medication, is being explored for its potential to modify disease progression by stabilizing neuronal activity and possibly reducing neurodegeneration. Researchers are excited about its novel approach, hoping it could offer a new pathway to slowing or altering Alzheimer's disease development.
What evidence suggests that levetiracetam might be an effective treatment for Alzheimer's Disease risk?
Research has shown that levetiracetam (LEV), a drug used to prevent seizures, might aid brain functions related to Alzheimer's Disease (AD). Some studies indicate that LEV can enhance spatial memory and executive function, which are types of thinking skills. In Alzheimer's patients with unusual brain activity, LEV improved thinking abilities. Animal studies demonstrated that LEV reduced abnormal brain signals and improved memory. These findings suggest that LEV could benefit those at risk for Alzheimer's by improving brain signaling and related thinking tasks. Participants in this trial will receive LEV in one phase and a placebo in another, allowing researchers to assess its potential benefits.23467
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?
This trial is for people in Toronto who have a parent or sibling with Alzheimer's disease, are worried about their memory but test normal on cognitive exams, and show certain brain changes on an MRI. Participants must be fluent in English and women must be post-menopausal or surgically sterile.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Participants receive either LEV or placebo for 4 weeks
Treatment Phase II
Participants crossover to receive the alternate treatment (LEV or placebo) for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levetiracetam
Trial Overview
The study tests if low doses of levetiracetam (LEV) can reduce abnormal brain activity linked to Alzheimer's risk. Each participant gets both LEV and placebo for 4 weeks each, in random order, along with cognitive tests and brain scans.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants randomized to Arm 2 will receive placebo in Treatment Phase I and LEV in Treatment Phase II.
Participants randomized to Arm 1 will receive LEV in Treatment Phase I and placebo in Treatment Phase II.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
University Health Network, Toronto
Collaborator
Weston Brain Institute
Collaborator
Citations
Cognitive Effect of Levetiracetam in Patients with Alzheimer's ...
They reported that LEV did not improve primary outcome, but in further analysis, LEV improved spatial memory performance and executive function tasks in ...
Effect of levetiracetam on cognition in patients with ... - PMC
While LEV did not improve general cognitive function, some studies reported small improvements in visuospatial and executive domains. More ...
Effect of Levetiracetam on Cognition in Patients With ...
In this randomized clinical trial of 34 adults with AD, treatment with levetiracetam did not significantly modify cognitive function.
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alzdiscovery.org
alzdiscovery.org/uploads/cognitive_vitality_media/Levetiracetam_UPDATE_%28drug%29.pdfLevetiracetam
In a 2024 meta-analysis of 16 randomized controlled trials including a total of 545 participants in various study populations (focal seizures, history of drug ...
An Investigation of Levetiracetam in Alzheimer's Disease
The anti-epileptic drug Levetiracetam can reduce abnormal brainwave activity and reverse memory deficits in a mouse model of Alzheimer's disease. Levetiracetam ...
An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD)
The anti-seizure medication levetiracetam can reduce abnormal cortical discharges and reverse memory deficits in a mouse model of Alzheimer's disease.
Safety, tolerability, and efficacy outcomes of the ...
This pilot study demonstrates that levetiracetam was well tolerated in individuals with Alzheimer's disease who do not have a history of ...
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