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Not yet recruitingPhase 1 / Phase 2

Epileptic Hippocampus in Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 days, 1 year
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The next day, a scalp EEG will be placed to record brain activity for six days and five nights in conjunction with the hippocampal depth electrode(s) already implanted."
  • "Participants will take brivaracetam twice a day for 1 year and will come back the University of California, Los Angeles (UCLA) at 3 months, 6 months, and 1 year to complete cognitive testing (ADAS-cog, Stroop Interference naming, and VRLT) and receive additional brivaracetam supplies."
  • "During the follow-up visits, blood samples will be collected to study plasma biomarkers of neurodegenerative diseases."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at unusual electrical activity in a brain area used for memory. It tests whether brivaracetam reduces this activity and affects thinking and memory. It is for adults ages 45 to 70 with mild thinking and memory problems due to Alzheimer's disease or with Alzheimer's disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 45 to 70 years old.
  • Meet study standards for mild thinking and memory problems or Alzheimer's disease, with test results that strongly suggest Alzheimer's-related brain changes.
  • Have seizure-like activity or unusually fast electrical signals recorded from the side or front-side areas of the brain.
  • Have someone who can share information about you, is willing to help, and has contact with you at least weekly.
  • Have a Mini-Mental State Examination score of at least 18, a Clinical Dementia Rating below 2, or both. These tests measure thinking, memory, and daily function.

Who can't join

  • Have seizure risk factors other than a disease that damages brain cells, or currently take anti-seizure medicine.
  • Have severe damage to the brain's white matter, which carries messages, or small deep strokes that doctors consider important.
  • Take medicines that prevent blood clots.
  • Have certain other brain or nerve conditions, such as lasting problems from a head injury, multiple sclerosis, Huntington's disease, fluid buildup in the brain, strokes, bleeding, or other important brain damage.
  • Have Korsakoff's syndrome, a serious memory disorder, or alcohol or drug misuse that began before dementia and was still present within 5 years of its start.
  • Have certain other illnesses, including untreated low vitamin B12 or folate, untreated syphilis, liver disease, kidney problems needing dialysis, brain or brain-lining infections, breathing problems needing oxygen, or an untreated low thyroid level.
  • Have another condition that the study doctors believe would make taking part too risky.
  • Take medicines likely to affect brain function, such as benzodiazepines or opioid pain medicines. Alzheimer's medicines called cholinesterase inhibitors and memantine are allowed if the dose has stayed the same for 30 days before joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Meet research criteria for mild cognitive impairment (Albert et al. 2011) or Alzheimer's disease (McKhann et al. 2011) with high biomarker probability of Alzheimer's disease pathophysiology * Ages 45 to 70 * Epileptic activity and/or pHFOs in temporal or fronto-temporal electrodes * 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. Exclusion Criteria: 1. Risk factors for epileptic activity besides neurodegenerative disease 2. Concurrent use of antiseizure medications 3. Severe periventricular white matter disease 4. Clinically significant lacunar infarcts 5. Anticoagulant use 6. Significant systemic medical illness: * History of Korsakoff's syndrome * Alcohol or substance abuse preceding dementia \& still present within 5 years of onset * Untreated vitamin B12 or folate deficiency * History of head trauma with persistent deficits * Untreated syphilis * History of multiple sclerosis or another neuro-inflammatory disorder * History of vascular or multi-infarct dementia * Diagnosis of Huntington's disease * History of normal pressure hydrocephalus * History of CNS lesions deemed to be clinically significant * Unresolved or present subdural hematoma * History of intracerebral hemorrhage * Systematic liver disease * Renal insufficiency requiring dialysis * Encephalitis or meningitis * Severe white matter disease as defined by a score of 3 on the age-related white matter changes scale * Lacunar infarcts deemed to be clinically significant * Cortical stroke * Respiratory condition requiring oxygen * Untreated hypothyroidism 7. Any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse event 8. Use of medications likely to affect CNS functions (e.g., benzodiazepines, narcotics). Patients are allowed to take cholinesterase inhibitors and memantine as long as the dosage is stable for 30 days prior to study entry.

Study sites (1)

CA