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Levetiracetam for Alzheimer's Disease (LeAD Trial)
LeAD Trial Summary
This trial is testing whether the drug levetiracetam can help improve cognition in patients with Alzheimer's disease by reducing cortical hyperexcitability and abnormalities in brain network function.
LeAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLeAD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2006 Phase 4 trial • 251 Patients • NCT00160654LeAD Trial Design
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- I have had fainting spells that might be seizures.You have had problems with drugs or alcohol in the past six months.I do not have a major psychiatric disorder except possibly depression.I do not have early Alzheimer's Disease.I am not on medications that affect brain activity, as confirmed by my doctor.You have problems with your brain or thinking abilities that are not normal.I have epilepsy or a close family member does, excluding minor seizures.I do not have a history of major neurological disorders or significant brain injuries.I am not currently taking any antiepileptic drugs.I have never had neurological disorders like epilepsy, stroke, or brain injuries.Your neurological exam shows no abnormalities.I do not have a major psychiatric disorder like schizophrenia, bipolar, or major depression.I've been on a steady dose of memory loss medication for at least 4 weeks.I have a history of seizures or epilepsy, or a close family member does, except for one benign seizure.My kidney function is significantly impaired.I regularly take medication to prevent frequent severe headaches.I have a chronic condition like heart issues or asthma that could worsen with a seizure.My tests show positive for amyloid in my brain.I am between 50 and 90 years old.You have had a severe head injury that caused you to be unconscious for a long time.I have been diagnosed with early-stage Alzheimer's Disease.
- Group 1: Early Alzheimer's Disease Group Low Dose
- Group 2: Early Alzheimer's Disease Group High Dose
- Group 3: Healthy Control Group
- Group 4: Early Alzheimer's Disease Group Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What past analyses have been conducted on the efficacy of Levetiracetam?
"Presently, 18 studies examining Levetiracetam are being conducted. 2 of these are Phase 3 trials and participants can be recruited from 40 different locations - most notably in Brisbane, Queensland."
Is enrollment for this research endeavor currently available to participants?
"According to the clinicaltrials.gov website, this research is actively searching for participants. It was first published on August 22nd 2019 and its information was recently updated on November 3rd 2021."
Are participants of over two decades old being incorporated into this trial?
"This medical trial only accepts patients aged between 50 and 90 years old. In comparison, 63 clinical trials are available for applicants younger than 18 while 1,122 studies cater to those above 65."
How many individuals have opted in to this experiment?
"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, initially posted on August 22nd 2019 is currently seeking patients. 85 participants must be recruited from 1 site for the study to continue."
Who qualifies to be a participant in this experiment?
"This trial seeks 85 individuals diagnosed with Alzheimer's disease between the ages of 50 and 90. To be eligible, applicants must meet a strict set of requirements such as having taken certain medications for memory loss over four consecutive weeks, meeting NINCDS-ADRDA criteria to establish probable AD diagnosis, scoring higher than 20 on MMSE tests, demonstrating positive amyloid status via cerebral spinal fluid biomarkers or PET scans, receiving CDR scores ranging from 0.5 to 1.0 (for those in the early stages of AD), passing normal neurologic exams (healthy control subjects only) and registering greater than 28 points on Mini Mental State"
Has the Food and Drug Administration authorized Levetiracetam for medical use?
"Considering the lack of evidence that supports levetiracetam's efficacy, it was assessed to have a safety rating of 2."
What medical condition is Levetiracetam usually prescribed to treat?
"For patients suffering from juvenile myoclonic epilepsy, Levetiracetam is frequently prescribed. This medication has also been seen to provide relief for those with a body weight above 20kgs, epilepsies, and other types of myoclonic seizures."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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