RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Within-subject, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101 (Low-dose Levetiracetam, 220 mg, Extended Release Tablet) for the Treatment of Hippocampal Overactivity in the Elderly

Quick Facts

Study Start:2025-05-01

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06919926

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Caroline L Wagandt, BA

CONTACT

410-955-5057

cspeck1@jhmi.edu

Principal Investigator

Arnold Bakker, Ph.D.

STUDY_DIRECTOR

Johns Hopkins University

Marilyn Albert, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Arnold Bakker, Ph.D., STUDY_DIRECTOR, Johns Hopkins University
Marilyn Albert, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Hippocampal Overactivity
Dementia