NCT01278407

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dementia With Lewy Bodies (DLB)

Interventions

Type	Name	Description
DRUG	Donepezil 5 mg	Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
DRUG	Donepezil 10 mg	Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
DRUG	Donepezil matched placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2011-01-17
• Last updated: 2023-06-29
• Results posted: 2015-11-30

Locations

56 sites across 1 country: Japan