A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

Dementia With Lewy Bodies (DLB) Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

Status Completed

Clinical Trial Summary

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Clinical Trial Description

This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed. ;

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies (DLB)
• Lewy Body Disease

• NCT number: NCT01278407
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Completion date: April 2013