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Trial record 1 of 1 for:    NCT00151398
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Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT00151398
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date February 11, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • The primary endpoints will be the change from baseline in ADAS-Cog total score
  • and ADCS-CGIC total score at week 12.
Change History Complete list of historical versions of study NCT00151398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. [ Time Frame: weeks 12, 14, 26 and 40. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • Secondary efficacy outcome variables include additional cognitive, functional,and
  • behavioral measures.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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.

  • Drug: Donepezil
    10 mg donepezil QD dosed up to 40 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: lecozotan SR
  • Experimental: B
    Intervention: Drug: lecozotan SR
  • Experimental: C
    Intervention: Drug: lecozotan SR
  • Active Comparator: D
    Intervention: Drug: Donepezil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
229
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
355
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151398
Other Study ID Numbers  ICMJE 3098B1-201, 3098B1-202
B343-1057, B343-1058 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2008

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