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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at enrollment, week 7, week 15, week 27, and month 12
Awards & highlights

LAPSE Trial 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.Check my eligibility
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.See study design
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.

LAPSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at enrollment, week 7, week 15, week 27, and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at enrollment, week 7, week 15, week 27, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Neuropsychiatric Inventory Score (NPI)
Secondary outcome measures
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 more

Side effects data

From 2006 Phase 4 trial • 251 Patients • NCT00160654
30%
Somnolence
14%
Dizziness
6%
Fatigue
6%
Nausea
6%
Headache
6%
Sedation
2%
Convulsion
1%
Grand mal convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam

LAPSE 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
137 Previous Clinical Trials
34,432 Total Patients Enrolled
Timothy R Malone, MDPrincipal InvestigatorWalter Reed National Military Medical Center

Media Library

Levetiracetam (Antiepileptic) Clinical Trial Eligibility Overview. Trial Name: NCT04004702 — Phase 2
Alzheimer's Disease Research Study Groups: Levetiracetam
Alzheimer's Disease Clinical Trial 2023: Levetiracetam Highlights & Side Effects. Trial Name: NCT04004702 — Phase 2
Levetiracetam (Antiepileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04004702 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with the administration of Levetiracetam?

"Leveraging existing clinical research, our team at Power has assigned Levetiracetam a score of two on the safety scale as this is currently in Phase 2. There are prelimary reports detailing its safety but no efficacy data yet."

Answered by AI

Is the enrollment stage of this research endeavor currently accepting participants?

"This research has ceased participant recruitment. It was initially listed on January 1st 2020 and modified lastly on June 27th 2019. If you are searching for other studies, there are currently 780 clinical trials actively recruiting patients with Alzheimer's disease and 18 trials exploring Levetiracetam which require participants."

Answered by AI

Has Levetiracetam previously been investigated in prior research?

"Currently, 18 medical trials involving Levetiracetam are underway with 2 of them in the final phase. The bulk of these studies occur at research centres located in Brisbane, Queensland; however, there are 40 sites overall carrying out such studies."

Answered by AI

To what extent is Levetiracetam used to treat medical conditions?

"Levetiracetam is employed in clinical settings to treat juvenile myoclonic epilepsy, as well as a range of other medical issues including epilepsies and myoclonic seizures for individuals with body masses that exceed 20 kilograms."

Answered by AI

How many participants are currently accepted for this clinical research?

"Unfortunately, no further recruitment is being conducted for this trial. The initial posting was on January 1st 2020 and the last update was June 27th 2019. As an alternative, there are currently 780 research projects recruiting individuals with Alzheimer's disease and 18 studies that require volunteers to take Levetiracetam."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~8 spots leftby Dec 2024