Epileptic Hippocampus in Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 2029-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Brivaracetam

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.