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Clinical Trial of AGB101 for Mild Cognitive Impairment | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Clinical Trial of AGB101 for Mild Cognitive Impairment

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101 on Slowing Progression of Mild Cognitive Impairment Due to Alzheimer's Disease in Apolipoprotein E4 Non-carriers

NCT05986721•AgeneBio

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by reduction in neuronal injury in participants with mild cognitive impairment due to Alzheimer's Disease. Participants will be randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary objectives are to assess the effect of AGB101 compared with placebo on clinical progression as measured by the Clinical Dementia Rating Scale- Sum of Boxes and Memory Box score.

Detailed Description

AGB101 is hypothesized to slow the progression of MCI due to AD by restoring the entorhinal/hippocampal network balance. During this phase of the disease, fMRI studies show hippocampal over-activity and EC under-activity. As shown in the phase 2 study, AGB101 restores this network balance by attenuating hippocampal over-activity and restoring EC activity. Hippocampal over-activity predicts progression on EC atrophy (primary endpoint) and on CDR-SB (secondary endpoint). By restoring network balance, AGB101 is hypothesized to improve cognitive function (CDR-SB) and reduce neuronal injury (EC atrophy).

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects between 55 and 85 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 with the subject to be able to provide assessment of memory changes, who can accompany the subject to the screening visit and all major clinic visits for the duration of those visits, and who is able to provide an independent evaluation of the subject's functioning.
•3. Have MCI as defined by all of the following criteria and consistent with the National Institute on Aging-Alzheimer's Association criteria:
•1. MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjects with \<8 years of education at the discretion of the sponsor).
•2. A memory complaint reported by the subject or his/her study partner.
•3. Evidence of lower memory performance based on the delayed recall portion on a list learning task (ISLT or BSRT).
+12 more criteria

Exclusion Criteria

•1. Carrying one or more copies of the apolipoprotein E4 (ApoeE4) allele.
•2. Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit.
•3. Use of anti-amyloid medications at any time prior to screening visit, or at any time during the study.
•4. Participation in a therapeutic clinical study for any medical or psychiatric indications within 3 months (6 months for biologics) of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they 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 3 months (6 months for biologics) prior to screening.
•5. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
•6. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
•7. Any significant neurological disease other than suspected incipient AD, such as Parkinson'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.
•8. 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.
•9. Diagnosis of bipolar disorder, or major depression within the past 3 years, as described in the DSM-5. Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. Subjects must not have a major depressive disorder or other types of depression that could confound diagnosis of MCI due to AD, or clinical assessments, in the opinion of the investigator. The Geriatric Depression Scale \[GDS\] (long form score \> 9 suggests depression) results should be reviewed by the investigator to assist in this determination.
•10. Modified Hachinski Ischemic Scale (HIS) score \> 4.
+9 more criteria

Locations (1)

Johns Hopkins

Baltimore, Maryland, United States

Key Dates

Start Date

December 3, 2024

Primary Completion Date

July 1, 2028

Completion Date

December 1, 2028

Last Updated

May 25, 2025

Conditions

Mild Cognitive ImpairmentProdromal Alzheimer's Disease

Interventions

AGB101

DRUG

Placebo

DRUG

Sense4Safety Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of AGB101 for Mild Cognitive Impairment

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

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