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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00151398
First received: September 6, 2005
Last updated: February 7, 2013
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
 Drug: lecozotan SR
Drug: Donepezil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. [ Time Frame: weeks 12, 14, 26 and 40. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. [ Time Frame: weeks 12, 14, 26 and 40. ] [ Designated as safety issue: Yes ]

Enrollment: 229
Study Start Date: September 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Experimental: B 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.
Experimental: C 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.
Active Comparator: D Drug: Donepezil
10 mg donepezil QD dosed up to 40 weeks

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151398

  Show 56 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
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00151398     History of Changes
Other Study ID Numbers: 3098B1-201, 3098B1-202, B343-1057, B343-1058
Study First Received: September 6, 2005
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013