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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00277810
First received: January 12, 2006
Last updated: February 14, 2013
Last verified: July 2008

January 12, 2006
February 14, 2013
March 2006
June 2008   (final data collection date for primary outcome measure)
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales [ Time Frame: 6 mo extension study: week 24 ] [ Designated as safety issue: Yes ]
All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
Complete list of historical versions of study NCT00277810 on ClinicalTrials.gov Archive Site
Score change from baseline to 24 weeks on functional and behavioral scales [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
Score change from baseline to 24 weeks on functional and behavioral scales
Not Provided
Not Provided
 
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Drug: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extesnion to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
  • Experimental: A
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: B
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: C
    Intervention: Drug: lecozotan SR (SRA-333)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   Finland,   France,   Italy,   Poland,   South Africa,   Spain,   United Kingdom
 
NCT00277810
3098B1-203, 3098B1-204
Yes
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Principal Investigator: Trial Manager For Argentina, scheima@wyeth.com or rendop@wyeth.com
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For South Africa, AZFinfo@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For Finland, MedInfoNord@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP