NCT00151398

Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	lecozotan SR	evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.
DRUG	Donepezil	10 mg donepezil QD dosed up to 40 weeks

Timeline

• Start date: 2005-10-06
• Primary completion: 2008-03-15
• Completion: 2008-03-15
• First posted: 2005-09-08
• Last updated: 2022-05-06

Locations

56 sites across 5 countries: United States, Argentina, Australia, Canada, South Africa