NCT05986721

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AgeneBio · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Mild Cognitive Impairment
• Prodromal Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	AGB101	low-dose levetiracetam, 220 mg, extended release tablet
DRUG	Placebo	Placebo oral tablet

Timeline

• Start date: 2024-12-03
• Primary completion: 2028-07-01
• Completion: 2028-12-01
• First posted: 2023-08-14
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study