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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
EHAD Trial 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.Check my eligibility
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.See study design
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.
EHAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Brivaracetam and Plasma Biomarkers
Brivaracetam on Cognition
Brivaracetam on Functional Decline
Side effects data
From 2022 Phase 3 trial • 449 Patients • NCT0308366519%
Somnolence
14%
Dizziness
7%
Nasopharyngitis
5%
Upper respiratory tract infection
5%
Headache
1%
Large intestine polyp
1%
Pyrexia
1%
Calculus ureteric
1%
Miscarriage of partner
100%
80%
60%
40%
20%
0%
Study treatment Arm
BRV 200 mg/Day
Placebo
BRV 50 mg/Day
BRV 50 mg/Day to OLTP BRV
Placebo to OLTP BRV
BRV 200 mg/Day to OLTP BRV
EHAD 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
~4510
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,826 Total Patients Enrolled
Keith A Vossel, MD, MScPrincipal InvestigatorMary S. Easton Center at UCLA
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking blood thinners.I have been diagnosed with mild cognitive impairment or Alzheimer's with a high likelihood of Alzheimer's disease.I have epilepsy activity in my brain's temporal or fronto-temporal areas.I am between 45 and 70 years old.I am currently taking medication for seizures.I have severe brain white matter disease.I don't have major health issues or untreated conditions that could risk my safety in the study.
Research Study Groups:
This trial has the following groups:- Group 1: BRIV Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial allow for geriatric participation?
"According to the information provided, this trial is only open for patients between 45 and 70 years old. In contrast, there are 152 separate trials available for those below 18 years of age or 1112 options for seniors above 65."
Answered by AI
Who is eligible to partake in this research study?
"To partake in this research, individuals need to possess mild cognitive impairment and be between 45-70 years old. Currently, the team is looking for 25 participants."
Answered by AI
Is this research venture currently taking on new participants?
"Per findings on clinicaltrials.gov, this particular medical trial is no longer in need of participants having been last revised on June 1st 2023. Despite the conclusion of its recruitment phase, there are still 1249 other studies with open opportunities for volunteers."
Answered by AI
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