drugset / Trial / NCT03486938

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

NCT03486938

Phase 2/3 Completed 164 enrolled AgeneBio National Institute on Aging (NIA) · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-12-13
Primary completion
2022-11-02
Completion
2022-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 220 mg Oral