Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hippocampal Overactivity, Dementia

In brief

This randomized, crossover, placebo controlled clinical study will assess the efficacy and safety of a slow release form of levetiracetam (AGB101) in the treatment of cognitively normal adults by measuring change in several imaging measures over the course of a two week treatment period.

Key facts

Study ID

NCT06919926

Run by

Johns Hopkins University

People needed

60

Starts

2025-04-17

Expected to finish

2028-05-01

Last updated by the study team

2026-07-15

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects must not meet any of the following exclusion criteria at screening:
• Use of anticonvulsant or anticoagulant medications within 1 month prior to the baseline visit.
• Participation in a therapeutic clinical study for any medical or psychiatric indications within 1 month of the screening visit, or at any time during the study. Subjects must understand that participants may only enroll in this clinical study once; participants may not enroll in any other clinical study while participating in the current study, and participants may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 1 month prior to screening.
• History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
• Severe renal impairment (creatinine clearance of < 30 mL/minute) or undergoing hemodialysis.
• Any significant neurological disease such as Parkinson's disease, Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, that in the opinion of the investigator might interfere with the conduct of the study.
• Diagnosis of major depression within the last 3 years or prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder.
• Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI scan.
• History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).
• Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
• Any unstable medical condition that is likely to require new medical or surgical treatment during the course of the study and where such treatments might affect the collection of efficacy data.
• Current suicidal ideation.
• Female subjects must not be pregnant or lactating.
• Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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