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Anti-epileptic drug

Brivaracetam for Alzheimer's Disease (EHAD Trial)

Phase 1 & 2

Waitlist Available

Led By Keith A Vossel, MD, MSc

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies brain activity in people with Alzheimer's and mild cognitive impairment, and the effect of a medication on cognition.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While not explicitly listed here, common side effects of Brivaracetam may include sleepiness, dizziness, fatigue, nausea and behavioral changes such as irritability or aggression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Brivaracetam and Plasma Biomarkers

Brivaracetam on Cognition

Brivaracetam on Functional Decline

Side effects data

From 2022 Phase 3 trial • 449 Patients • NCT03083665

19%

Somnolence

14%

Dizziness

Nasopharyngitis

Upper respiratory tract infection

Headache

Miscarriage of partner

Pyrexia

Calculus ureteric

Large intestine polyp

100%

80%

60%

40%

20%

Study treatment Arm

BRV 200 mg/Day

Placebo

BRV 50 mg/Day

Placebo to OLTP BRV

BRV 50 mg/Day to OLTP BRV

BRV 200 mg/Day to OLTP BRV

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brivaracetam

2019

Completed Phase 3

~4500

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