Brivaracetam for Alzheimer's Disease
(EHAD Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKeith A Vossel, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Approved in 5 Jurisdictions

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.

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

Willing and able informant who has at least weekly contact with subject

Mini-Mental State Examination score of 18 or greater and/or Clinical Dementia Rating less than 2. These two examinations will be obtained from their participation in UCLA IRB#21-001603 or will be collected if subjects are referred by a clinician.

I have been diagnosed with mild cognitive impairment or Alzheimer's with a high likelihood of Alzheimer's disease.

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Exclusion Criteria

I am currently taking blood thinners.

Risk factors for epileptic activity besides neurodegenerative disease

Clinically significant lacunar infarcts

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Treatment Details

Interventions

Brivaracetam (Anti-epileptic drug)

Trial OverviewThe study aims to understand hippocampal activity in Alzheimer's patients with suspected epilepsy and test if Brivaracetam can reduce this abnormal activity and improve cognition. It involves monitoring through depth electrode and scalp EEG in an open-label pilot setup where all participants receive the drug.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: BRIV ExperimentalExperimental Treatment1 Intervention

25 subjects with MCI or AD who meet inclusion criteria will receive the drug: brivaracetam. A scalp EEG will record their brain activity for 6 days at the hospital. On nights 4 and 5, we will intravenously administer brivaracetam. Doses will vary depending on their effects on epileptic activity. We will determine whether brivaracetam 25 mg IV suppresses the number of epileptic events and pHFOs by \>50%, which is analogous to our preclinical investigations with this drug in AD models. If the 50% suppression is reached, the same dosage will be repeated the following night to ensure reproducibility. If the 50% suppression is not reached, then the dosage of brivaracetam will be increased to 50 mg the following night. Once the depth electrode is surgically removed, subjects will go home with a supply of brivaracetam. They will take the drug for 12 months.

Brivaracetam is already approved in Canada for the following indications: