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

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: lecozotan SR; Drug: Donepezil

• Registration Number: NCT00151398
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Study Start: 2005-10-06
• Primary Completion: 2008-03-15
• Study Completion: 2008-03-15
• Disposition First Submitted: 2013-02-07
• Disposition First Submitted QC: 2013-02-07
• Disposition First Posted: 2013-02-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

• Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
• Able to give informed consent. Patient' s caregiver must consent to participate in the study.

Exclusion Criteria

• Use of medications for cognitive enhancement within 3 months of baseline.
• Significant neurologic disease other than AD that may affect cognition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	lecozotan SR	-
C	lecozotan SR	-
B	lecozotan SR	-
D	Donepezil	-

Primary Outcome Measures

Name	Time	Method
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.	weeks 12, 14, 26 and 40.

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.	weeks 12, 14, 26 and 40.