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

Alzheimer Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151398
• Other study ID #: 3098B1-201, 3098B1-202
• Secondary ID: B343-1057, B343-
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2005
• Est. completion date: March 15, 2008

Study information

• Verified date: April 2022
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: March 15, 2008
• Est. primary completion date: March 15, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.
• Donepezil
10 mg donepezil QD dosed up to 40 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.		weeks 12, 14, 26 and 40.