Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

A 6-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 Treated With a Cholinesterase Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277810
• Other study ID #: 3098B1-203, 3098B1-204
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of probable Alzheimer`s disease

• Current use of cholinesterase inhibitor

• Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study

Exclusion Criteria:

• Significant neurological disease other than AD

• Diagnosis of major depression

• History of stroke or other heart disease

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Finland,  France,  Italy,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales		6 mo extension study: week 24
Secondary	Score change from baseline to 24 weeks on functional and behavioral scales		week 24