Your session is about to expire
← Back to Search
Antiepileptic
Levetiracetam for Alzheimer's Disease (LeAD Trial)
Phase 2
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On a stable dose of medications for memory loss including cholinesterase inhibitors (for example: donepezil, rivastigmine or memantine) as defined by 4 consecutive weeks of treatment at an unchanging dose
Positive amyloid status (as defined by cerebral spinal fluid biomarkers or amyloid positron emission tomography (PET) study.
Must not have
History of fainting spells of unknown or undetermined etiology that might constitute seizures.
Exclusion Criteria Subjects with early Alzheimer's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until the end of the treatment periods at 5 months
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.
Who is the study for?
This trial is for adults aged 50-90 with early Alzheimer's Disease (AD) or mild cognitive impairment, having a Mini Mental State Examination (MMSE) score of ≥20 and positive amyloid status. They must be on stable memory loss medication for at least four weeks. Excluded are those with epilepsy, significant neurological history, major psychiatric disorders, metal implants not cleared for MRI/TMS, severe kidney issues, or uncontrolled medical conditions.
What is being tested?
The study tests if the antiepileptic drug Levetiracetam can normalize brain function and improve cognition in AD patients by reducing cortical hyperexcitability. Participants will either receive Levetiracetam or a placebo capsule to compare effects on cognitive dysfunction associated with AD.
What are the potential side effects?
Levetiracetam may cause side effects such as drowsiness, weakness, infection risk increase due to immune system effect, coordination difficulties potentially affecting balance and movement control; mood changes including anxiety or depression; and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on a steady dose of memory loss medication for at least 4 weeks.
Select...
My tests show positive for amyloid in my brain.
Select...
I am between 50 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had fainting spells that might be seizures.
Select...
I do not have early Alzheimer's Disease.
Select...
I do not have a history of major neurological disorders or significant brain injuries.
Select...
I have never had neurological disorders like epilepsy, stroke, or brain injuries.
Select...
I do not have a major psychiatric disorder like schizophrenia, bipolar, or major depression.
Select...
My kidney function is significantly impaired.
Select...
I regularly take medication to prevent frequent severe headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment until the end of the treatment periods at 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until the end of the treatment periods at 5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in beta power after theta-burst stimulation
Change in motor evoked potential (MEP) amplitude
Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity
+5 moreOther study objectives
Interictal Epileptiform Discharges
Transcranial magnetic stimulation (TMS)-evoked N45 electroencephalogram (EEG) potential
Side effects data
From 2023 Phase 4 trial • 82 Patients • NCT018010728%
Seizure
5%
Stroke
3%
Patient received extra Keppra
3%
Delirium
3%
Headache
3%
Unexplained Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
No Levetiracetam
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Early Alzheimer's Disease Group Low DoseExperimental Treatment1 Intervention
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of low-dose levetiracetam (125 mg twice daily)
Group II: Early Alzheimer's Disease Group High DoseExperimental Treatment1 Intervention
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of high-dose levetiracetam (500mg twice daily).
Group III: Healthy Control GroupActive Control1 Intervention
A group of demographically similar subjects without Alzheimer's Disease will undergo baseline testing only, without any intervention
Group IV: Early Alzheimer's Disease Group PlaceboPlacebo Group1 Intervention
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of placebo twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
2017
Completed Phase 4
~3650
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,741 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.