At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Placebo Oral Tablet and AGB101 220 mg tablet for Mild Cognitive Impairment and Prodromal Alzheimer's Disease. Completed, enrolled 164 participants across 24 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Placebo oral tablet
220 mg AGB101 active compound