NCT03486938

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101on Slowing Progression of Mild Cognitive Impairment Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 164 (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 changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. 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 Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ).

Conditions

• Mild Cognitive Impairment
• Prodromal Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	Placebo oral tablet
DRUG	AGB101 220 mg tablet	220 mg AGB101 active compound

Timeline

• Start date: 2018-12-13
• Primary completion: 2022-11-02
• Completion: 2022-11-02
• First posted: 2018-04-03
• Last updated: 2024-05-17
• Results posted: 2024-05-17

Locations

24 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study