Brivaracetam for Alzheimer's Disease
(EHAD Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, especially if they affect the central nervous system (like benzodiazepines or narcotics) or are antiseizure medications. However, you can continue taking cholinesterase inhibitors and memantine if your dosage has been stable for at least 30 days before joining the study.
How does the drug Brivaracetam differ from other Alzheimer's treatments?
Research Team
Keith A Vossel, MD, MSc
Principal Investigator
Mary S. Easton Center at UCLA
Eligibility Criteria
This trial is for adults aged 45-70 with mild cognitive impairment or Alzheimer's, showing specific epileptic activity on EEG. Participants need a reliable informant and must meet certain criteria including scoring above 18 on the Mini-Mental State Exam. Those with other risk factors for epilepsy, using antiseizure meds, significant brain lesions or systemic illnesses, or affecting CNS medications can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgical Assessment
Participants undergo MRV, MRA, gadolinium-enhanced MRI, and cognitive testing prior to electrode implantation
Surgical and Initial Treatment
Hippocampal depth electrodes are implanted, and brivaracetam is administered intravenously to assess its effects on epileptic activity
Long-term Treatment
Participants take brivaracetam orally for 1 year with follow-up visits for cognitive testing and biomarker analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brivaracetam
Brivaracetam is already approved in European Union, United States, Canada for the following indications:
- Partial-onset seizures with or without secondary generalisation
- Focal (partial) onset seizures in epilepsy patients 1 month of age and older
- Partial-onset seizures with or without secondary generalisation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor