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

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).

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

Conditions

Alzheimer Disease

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales

Secondary Outcome Measures:

• Score change from baseline to 24 weeks on functional and behavioral scales

Study Start

March 2006; Study completion: January 2008

Eligibility & Criteria

• Ages Eligible for Study: 50 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

284

Contact Details

• East Gosford, 2250, Australia
• Hornsby, 2077, Australia
• Victoria, 3081, Australia
• Adelaide, 5000, Australia
• Randwick, 2031, Australia

Email: medinfo@wyeth.com or Contact Wyeth

• Study ID Numbers: 3098B1-203, 3098B1-204 or NCT00277810