Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE)

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID: NCT04004702
Run by: Walter Reed National Military Medical Center
People needed: 65
Starts: 2020-01-01
Expected to finish: 2025-06-01
Last updated by the study team: 2019-07-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meet the National Institute of Aging-Alzheimer's Association criteria for probable AD
Twelve-item Neuropsychiatric Inventory with score 4 or greater
MMSE <26
Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry
Reliable caregiver willing and available to assist with medication administration, outcome measures
MRI completed with no evidence of potential seizure focus as outlined in the exclusion criteria

You may not qualify if…

Imaging suggestive of potential seizure focus or alternative cause of dementia
Previous Epilepsy diagnosis
Use of anti-epileptic medication for any indication within previous three months
History of head trauma with loss of consciousness more than 30 minutes
Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years
History of Korsakoff's syndrome
History of encephalitis/meningitis
Female participant who is pregnant, lactating or planning pregnancy during trial
Scheduled elective surgery or other procedures requiring general anesthesia during the trial
Participant with life expectancy of less than 12 months
Any cancer requiring current chemotherapy
Known allergy or history of previous adverse reaction to levetiracetam
Major depression or other significant behavioral disturbance preceding Alzheimer's Disease diagnosis
Enrollment in another clinical treatment trial
Laboratory evidence of an alternative cause of dementia or which might preclude treatment, including untreated vitamin B12 deficiency, untreated hypothyroidism, syphilis, positive human immunodeficiency virus testing, end-stage renal disease on dialysis, significant renal impairment (creatinine clearance <75 ml/minute), or liver function tests >2x upper limit of normal within the preceding three months

Where it is running

Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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