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Antiepileptic
Levetiracetam for Alzheimer's Disease (LAPSE Trial)
Phase 2
Waitlist Available
Led By Timothy R Malone, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
History of encephalitis/meningitis
Previous Epilepsy diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at enrollment, week 7, week 15, week 27, and month 12
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will study whether or not treating seizures can improve neuro-psychiatric symptoms in Alzheimer's patients.
Who is the study for?
This trial is for people with Alzheimer's who show signs of agitation or depression (neuro-psychiatric symptoms) and have had a recent brain scan without seizure indicators. They must score below 26 on the MMSE, indicating cognitive impairment, and be on stable medication doses. A reliable caregiver is required to help them throughout the study.
What is being tested?
The LAPSE trial tests if Levetiracetam can reduce neuro-psychiatric symptoms in Alzheimer's patients with seizure-like activity. Participants will take this drug for a year while their symptoms, cognition, quality of life, and disease severity are monitored.
What are the potential side effects?
Levetiracetam may cause side effects such as drowsiness, weakness, infection risk increase due to lowered blood cell counts, loss of appetite or digestive issues like nausea or vomiting; mood changes including anxiety or depression; skin reactions; and other potential nervous system effects.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had encephalitis or meningitis in the past.
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I have been diagnosed with epilepsy.
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I had major depression or behavioral issues before my Alzheimer's diagnosis.
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I have had a head injury that made me unconscious for over 30 minutes.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.
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I have a history of Korsakoff's syndrome.
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I have surgery planned that will need general anesthesia during the trial.
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My cancer needs chemotherapy now.
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I do not have conditions like severe kidney, liver issues, or untreated vitamin deficiencies that could explain my memory problems.
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My scans show possible reasons for seizures or memory loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at enrollment, week 7, week 15, week 27, and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at enrollment, week 7, week 15, week 27, and month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Neuropsychiatric Inventory Score (NPI)
Secondary study objectives
Change in Alzheimer's Disease Cooperative study - Clinical Global Impression of Change (ADCS-CGIC)
Change in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Change in EuroQol 5-Dimension (EQ-5D)
+1 moreSide effects data
From 2023 Phase 4 trial • 82 Patients • NCT018010728%
Seizure
5%
Stroke
3%
Delirium
3%
Patient received extra Keppra
3%
Headache
3%
Unexplained Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
No Levetiracetam
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LevetiracetamExperimental Treatment1 Intervention
All patients with epileptiform activity on initial screening EEG will receive levetiracetam for 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
FDA approved
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,262 Total Patients Enrolled
Timothy R Malone, MDPrincipal InvestigatorWalter Reed National Military Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not expected to live for more than 12 months.I have had encephalitis or meningitis in the past.I have been diagnosed with epilepsy.I had major depression or behavioral issues before my Alzheimer's diagnosis.My current medications have been the same for at least 4 weeks.I have had a head injury that made me unconscious for over 30 minutes.I have taken anti-epileptic medication in the last 3 months.You have a history of alcohol or drug abuse within the last 5 years.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.You have been diagnosed with Alzheimer's disease according to specific criteria.I have a history of Korsakoff's syndrome.I have surgery planned that will need general anesthesia during the trial.My cancer needs chemotherapy now.I do not have conditions like severe kidney, liver issues, or untreated vitamin deficiencies that could explain my memory problems.You have had an allergic reaction to levetiracetam in the past.Your memory and thinking skills score is less than 26.Your MRI scan doesn't show any signs of possible seizure spots.You have a score of 4 or higher on the Twelve-item Neuropsychiatric Inventory.My scans show possible reasons for seizures or memory loss.
Research Study Groups:
This trial has the following groups:- Group 1: Levetiracetam
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.