Epileptic Hippocampus in Alzheimer's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05899764
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Brivaracetam — DRUG
    * 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jun 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BRIV Experimental
    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.

Primary Outcome Measure

Brivaracetam on Cognition [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mary S. Easton Center for Alzheimer's Research and CareLos AngelesCalifornia90095-1769
Katy A Figueroa, BS
[email protected]
310-206-8993
Sydney Kilgore, BA
[email protected]
3108253198
Keith A Vossel, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Mary S. Easton Center for Alzheimer's Research and Care· Los Angeles, CA

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