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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Levetiracetam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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