← Trials/Trial dossier/NCT05899764

EHAD

Not yet recruitingPhase 1 / PHASE2

Epileptic Hippocampus in Alzheimer's Disease

Lead sponsor

University of California, Los Angeles

Asset

Brivaracetam

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE 18

Primary endpoint

•Brivaracetam on Cognition

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID22-001000

NCT IDNCT05899764

Timeline

Milestones

Study first posted2023-06-12actual

Study start2026-01-01estimated

Last update posted2026-01-27actual

Primary completion2029-06-01estimated

Study completion2029-06-01estimated

Assets

Drug assets

Brivaracetam

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age45 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Tau biomarkers

Neurodegeneration biomarkers

Amyloid biomarkers

Global cognition

6 endpoints

Primary/protocol endpoint

Brivaracetam on Cognition

Time frame:3 months

descriptive

Primary/protocol endpoint

Brivaracetam on Cognition

Time frame:3 months

descriptive

Secondary/protocol endpoint

Brivaracetam on Cognition

Time frame:12 months

descriptive

Secondary/protocol endpoint

Brivaracetam on Cognition

Time frame:12 months

descriptive

Secondary/protocol endpoint

Brivaracetam on Cognition

Time frame:12 months

ADAS-Cog

descriptive

Secondary/protocol endpoint

Brivaracetam on Functional Decline

Time frame:12 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive