Levetiracetam for Alzheimer's Disease

(LAPSE Trial)

Overseen By Timothy R Malone, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Anti-epileptics

Disqualifiers: Epilepsy, Head trauma, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 52 weeks

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with Alzheimer's disease (AD) are increasingly recognized to have seizures in addition to cognitive decline. Seizures may contribute to memory problems as well as other symptoms common in AD like agitation, depression, or apathy. These symptoms are collectively called neuro-psychiatric symptoms. Studies of magnetic resonance imaging (MRI) in patients with AD have suggested that injury to certain parts of the brain can cause these neuro-psychiatric symptoms. Based on this evidence, the investigators hypothesize that seizures can also cause neuro-psychiatric symptoms in patients with AD and may be related to the injury seen on MRI. The current study will follow participants for 1 year and will involve participants with AD who also have neuro-psychiatric symptoms. Participants will be examined with three brain wave studies to assess for seizure-like activity. Participants with seizure-like activity will all receive levetiracetam for 1 year. All participants will have their neuro-psychiatric symptoms, cognitive abilities, quality of life, and AD severity assessed throughout the year. The investigators plan to determine if levetiracetam changes the severity of the participants' neuro-psychiatric symptoms compared to their baseline as well as compared to participants without seizure-like activity. 65 participants will need to be recruited to test the study hypotheses. The study will take place at Walter Reed National Military Medical Center.

Who Is on the Research Team?

Timothy R Malone, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My current medications have been the same for at least 4 weeks.

You have been diagnosed with Alzheimer's disease according to specific criteria.

Reliable caregiver willing and available to assist with medication administration, outcome measures

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Participants undergo EEG to identify epileptiform activity

1 week

1 visit (in-person)

Treatment

Participants with epileptiform activity receive levetiracetam for 1 year

52 weeks

4 visits (in-person) at week 7, week 15, week 27, and month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levetiracetam

Trial Overview 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.

How Is the Trial Designed?

Group I: Levetiracetam Experimental Treatment 1 Intervention

All patients with epileptiform activity on initial screening EEG will receive levetiracetam for 1 year

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+