Could a Low-Dose epilepsy drug protect aging brains?
NCT ID NCT06919926
First seen Jun 24, 2026 · Last updated Sep 01, 2026 · Updated 5 times
Summary
This study tests whether a low-dose extended-release version of levetiracetam (AGB101) can reduce overactivity in the hippocampus, a brain region often overactive in early dementia. Sixty adults aged 50–80 with normal thinking skills will take the drug or a placebo for two weeks each, and brain scans will measure changes. The goal is to see if calming this overactivity could help prevent or delay memory decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AGB101 (low-dose levetiracetam, 220 mg extended release tablet)
- What this could lead to
- If it works, this could point toward a treatment that reduces abnormal brain activity linked to memory loss and dementia in older adults.
- What could go wrong
- This is a small, early Phase 2 trial with only 60 participants and a short 2-week treatment period. It measures brain imaging changes, not actual memory or thinking improvements, so success is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2025
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Subjects must meet all of the following inclusion criteria at screening: 1. Subjects between 50 and 80 years old (inclusive) in good general health: 1. Willing and able to consent and participate for the duration of the study. 2. Have eighth-grade education or good work history sufficient to exclude mental retardation. 3. Have visual and auditory acuity adequate for neuropsychological testing. 4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments. 2. Have a study partner who has sufficient contact (≥ 2 hours per week) with the subject and can provide assessments of any changes and an independent evaluation of the subject's functioning. 3. Have normal cognition as defined by the following criteria: 1. Mini-Mental State Examination (MMSE) scores between 27 and 30 (inclusive; exceptions may be made for subjects with \< 12 years of education at the discretion of the investigator) 2. No memory complaint reported by the subject or his/her study partner. 3. Evidence of normal memory function documented by a normal score on the Buschke Selective Reminding Test Immediate and Delayed Recall or equivalent test. 4. A Clinical Dementia Rating Scale (CDR) global score of 0 with a memory box score of 0. 4. Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study. 5. Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI. 6. Willing to allow collection of blood for apolipoprotein E (ApoE) genotyping and banking. 7. If female participant or partner/spouse is of childbearing age, participant and/or partner must be willing to use an effective contraception for duration of the study and for 4 days after it. For women, effective contraception may be hormonal; for men, a condom. Exclusion Criteria: * Subjects must not meet any of the following exclusion criteria at screening: 1. Use of anticonvulsant or anticoagulant medications within 1 month prior to the baseline visit. 2. 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. 3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam). 4. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis. 5. 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. 6. Diagnosis of major depression within the last 3 years or prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder. 7. 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. 8. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria). 9. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements. 10. 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. 11. Current suicidal ideation. 12. Female subjects must not be pregnant or lactating. 13. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
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