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Tests treatment safety and results for Hippocampal Overactivity
Official title Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults
ClinicalTrials.gov ID: NCT06919926
What this study is testing
What is AGB101?
AGB101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hippocampal overactivity.
Also referred to as levetiracetam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join if
- people must meet all of the following at screening:
- people between 50 and 80 years old (inclusive) in good general health:
- Willing and able to consent and participate for the duration of the study.
- Have eighth-grade education or good work history sufficient to exclude mental retardation.
- Have visual and auditory acuity adequate for neuropsychological testing.
You likely can't join if
- people 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...
- History of hypersensitivity or lack of side effects 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...
See the full eligibility criteria
- people must meet all of the following at screening:
- people between 50 and 80 years old (inclusive) in good general health:
- Willing and able to consent and participate for the duration of the study.
- Have eighth-grade education or good work history sufficient to exclude mental retardation.
- Have visual and auditory acuity adequate for neuropsychological testing.
- Have proficient fluency of the native local language to participate in all the neuropsychological test assessments.
- 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.
- Have normal cognition as defined by the following criteria:
- Mini-Mental State Examination (MMSE) scores between 27 and 30 (inclusive; exceptions may be made for people with \< 12 years of education at the discretion of the investigator)
- No memory complaint reported by the subject or his/her study partner.
- Evidence of normal memory function documented by a normal score on the Buschke Selective Reminding Test Immediate and Delayed Recall or equivalent test.
- A Clinical Dementia Rating Scale (CDR) global score of 0 with a memory box score of 0.
- Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.
- Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI.
- Willing to allow collection of blood for apolipoprotein E (ApoE) genotyping and banking.
- 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...
- people 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. people must understand that participants may only enroll...
- History of hypersensitivity or lack of side effects 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...
- 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 how well it works data.
- Current suicidal ideation.
- Female people must not be pregnant or lactating.
- Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.