NCT02956486

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,212 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Elenbecestat	Oral tablet.
DRUG	Placebo	Oral tablet.

Timeline

• Start date: 2016-10-20
• Primary completion: 2020-01-15
• Completion: 2020-01-15
• First posted: 2016-11-07
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

258 sites across 18 countries: United States, Argentina, Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Greece, Japan, Poland, Portugal, Russia, Slovakia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study