25 Participants Needed

Brivaracetam for Alzheimer's Disease

(EHAD Trial)

Recruiting at 1 trial location
AM
SK
KA
KA
SR
Overseen BySydney R Kilgore, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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?

Brivaracetam is unique because it is primarily used as an anti-seizure medication, unlike the typical Alzheimer's treatments which are cholinesterase inhibitors or memantine. This suggests a novel approach to Alzheimer's treatment, potentially targeting different pathways in the brain.12345

Research Team

KA

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.
See 2 more

Exclusion Criteria

I am currently taking blood thinners.
Risk factors for epileptic activity besides neurodegenerative disease
Clinically significant lacunar infarcts
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-surgical Assessment

Participants undergo MRV, MRA, gadolinium-enhanced MRI, and cognitive testing prior to electrode implantation

2 weeks
Multiple visits (in-person)

Surgical and Initial Treatment

Hippocampal depth electrodes are implanted, and brivaracetam is administered intravenously to assess its effects on epileptic activity

1 week
7 days (in-patient)

Long-term Treatment

Participants take brivaracetam orally for 1 year with follow-up visits for cognitive testing and biomarker analysis

12 months
3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Brivaracetam
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 European Union, United States, Canada for the following indications:

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Approved in European Union as Briviact for:
  • Partial-onset seizures with or without secondary generalisation
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Approved in United States as Briviact for:
  • Focal (partial) onset seizures in epilepsy patients 1 month of age and older
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Approved in Canada as Brivlera for:
  • 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

Trials
1,594
Recruited
10,430,000+

References

Oral tetrahydroaminoacridine treatment of Alzheimer's disease evaluated clinically and by regional cerebral blood flow and EEG. [2019]
Retrospective study on the benefits of combined Memantine and cholinEsterase inhibitor treatMent in AGEd Patients affected with Alzheimer's Disease: the MEMAGE study. [2022]
TV 3326 for Alzheimer's dementia: a novel multimodal ChE and MAO inhibitors to mitigate Alzheimer's-like neuropathology. [2021]
Systematic review and meta-analysis of combination therapy with cholinesterase inhibitors and memantine in Alzheimer's disease and other dementias. [2022]
Antidementia drug use among community-dwelling individuals with Alzheimer's disease in Finland: a nationwide register-based study. [2021]