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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

September 6, 2005
September 8, 2005
February 11, 2013
September 2005
March 2008   (Final data collection date for primary outcome measure)
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. ]
  • The primary endpoints will be the change from baseline in ADAS-Cog total score
  • and ADCS-CGIC total score at week 12.
Complete list of historical versions of study NCT00151398 on ClinicalTrials.gov Archive Site
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. [ Time Frame: weeks 12, 14, 26 and 40. ]
  • Secondary efficacy outcome variables include additional cognitive, functional,and
  • behavioral measures.
Not Provided
Not Provided
 
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • 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
  • Experimental: A
    Intervention: Drug: lecozotan SR
  • Experimental: B
    Intervention: Drug: lecozotan SR
  • Experimental: C
    Intervention: Drug: lecozotan SR
  • Active Comparator: D
    Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
355
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   South Africa,   United States
 
 
NCT00151398
3098B1-201, 3098B1-202
B343-1057, B343-1058 ( Other Identifier: Pfizer )
Yes
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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