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

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ClinicalTrials.gov Identifier: NCT00277810
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : February 21, 2013
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: lecozotan SR (SRA-333) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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: B 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: C 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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Score change from baseline to 24 weeks on functional and behavioral scales [ Time Frame: week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277810


  Show 83 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00277810     History of Changes
Other Study ID Numbers: 3098B1-203, 3098B1-204
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: July 2008

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer's Disease
Cholinesterase Inhibitors
Outpatients

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs