Epileptic Hippocampus in Alzheimer's Disease
NCT: NCT05899764 ·
Status: NOT YET RECRUITING ·
Phase: Phase 2
· Sponsor: University of California, Los Angeles
· Started: 2026-01-01
· Est. Completion: 2029-06-01
Official Summary
The major goals of the study are to 1) characterize hippocampal activity in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD who have suspected hippocampal epileptic activity based on scalp EEG recordings from IRB # 21-001603; 2) study the efficacy of brivaracetam to suppress epileptic activity and pathological high frequency oscilations (pHFOs) during hippocampal depth electrode and scalp EEG in patients with MCI and AD; and 3) investigate the effects of brivaracetam on cognition in an open-label pilot study.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 25 participants
Interventions
- DRUG: Brivaracetam — * Intravenous administration: 25 mg or 50 mg will be administered depending on its effects on epileptic activity during a hospital stay where simultaneous EEG and depth electrode recordings will be measuring epileptic activity. * Oral administration: Subjects will take 25mg or 50mg twice a day for 12 months. The dosage will depend on its effects on epileptic activity. Brivaracetam levels will be measured on months 3, 6 and 12.
Primary Outcomes
- Brivaracetam on Cognition (3 months)
- Brivaracetam on Cognition (3 months)
Secondary Outcomes
- Brivaracetam on Cognition (12 months)
- Brivaracetam on Cognition (12 months)
- Brivaracetam on Cognition (12 months)
- Brivaracetam on Functional Decline (12 months)
- Brivaracetam and Plasma Biomarkers (12 months)
Trial Locations
- Mary S. Easton Center for Alzheimer's Research and Care, Los Angeles, California, United States
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.