Actively Recruiting
Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults
Led by Johns Hopkins University · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
A
AgeneBio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years inclusive and in good general health
- Willing and able to consent and participate for the full study duration
- Completed at least eighth-grade education or have a good work history
- Adequate vision and hearing for neuropsychological testing
- Fluent in the native local language for test participation
- Have a study partner with at least 2 hours weekly contact who can assess changes and functioning
- Normal cognition defined by MMSE scores 27 to 30, no memory complaints, normal memory test scores, and CDR global score of 0
- Stable dose of antidepressants for at least 1 month prior and expected to remain stable
- Willing and able to undergo repeated 3 Tesla MRI scans with no contraindications
- Willing to provide blood for ApoE genetic testing and banking
- Willing and able to have a Tau PET scan with 18F MK-6240 tracer
- If female or partner of childbearing age, willing to use effective contraception during the study and for 4 days after
You will not qualify if you...
- Use of anticonvulsant or anticoagulant medications within 1 month prior to baseline
- Participation in any therapeutic clinical study within 1 month before screening or during the study
- History of hypersensitivity or intolerance to AGB101 (levetiracetam)
- Severe renal impairment (creatinine clearance <30 mL/min) or on hemodialysis
- Significant neurological diseases that might interfere with the study (e.g., Parkinson's, Alzheimer's, seizure disorder, brain tumor)
- Major depression diagnosis within past 3 years or history of schizophrenia, bipolar disorder, or other psychotic disorders
- Presence of devices or metal objects contraindicating MRI
- History of alcohol or substance abuse within past 3 years
- Significant systemic illness or unstable medical condition affecting protocol compliance
- Medical conditions likely to require new treatments affecting efficacy data collection
- Current suicidal ideation
- Pregnancy or lactation
- Any other condition that could confound study interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Caroline L Wagandt, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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