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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 below
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I've been on a steady dose of memory loss medication for at least 4 weeks.
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My tests show positive for amyloid in my brain.
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I am between 50 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had fainting spells that might be seizures.
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I do not have early Alzheimer's Disease.
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I do not have a history of major neurological disorders or significant brain injuries.
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I have never had neurological disorders like epilepsy, stroke, or brain injuries.
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I do not have a major psychiatric disorder like schizophrenia, bipolar, or major depression.
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My kidney function is significantly impaired.
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I regularly take medication to prevent frequent severe headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until the end of the treatment periods at 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until the end of the treatment periods at 5 months for reporting.

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 more
Other study objectives
Interictal Epileptiform Discharges
Transcranial magnetic stimulation (TMS)-evoked N45 electroencephalogram (EEG) potential

Side effects data

From 2006 Phase 4 trial • 251 Patients • NCT00160654
30%
Somnolence
14%
Dizziness
6%
Nausea
6%
Fatigue
6%
Headache
6%
Sedation
2%
Convulsion
1%
Grand mal convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
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
855 Previous Clinical Trials
12,930,876 Total Patients Enrolled

Media Library

Levetiracetam (Antiepileptic) Clinical Trial Eligibility Overview. Trial Name: NCT03875638 — Phase 2
Alzheimer's Disease Research Study Groups: Early Alzheimer's Disease Group Low Dose, Early Alzheimer's Disease Group High Dose, Healthy Control Group, Early Alzheimer's Disease Group Placebo
Alzheimer's Disease Clinical Trial 2023: Levetiracetam Highlights & Side Effects. Trial Name: NCT03875638 — Phase 2
Levetiracetam (Antiepileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03875638 — Phase 2
~14 spots leftby Nov 2025
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