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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06919926
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dementia
  • Hippocampal Overactivity

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • AGB101 — DRUG
    low-dose levetiracetam, 220 mg, extended release tablet
  • Placebo — DRUG
    placebo capsule

Study Details

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 Dates

Start date
Apr 17, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AGB101 first, then placebo
    AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 2 weeks, washout (4 weeks), then placebo capsule once daily for 2 weeks.
  • Experimental: placebo first, then AGB101
    Placebo capsule once daily for 2 weeks, washout (4 weeks), then AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 2 weeks.

Primary Outcome Measure

Change in hippocampal overactivity as measured by fMRI (functional Magnetic Resonance Imaging) [ Time Frame: Week 2, Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21287
Caroline L Wagandt, BA
[email protected]
410-955-5057
Marilyn Albert, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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