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

Last updated on November 13, 2019

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Study Location
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Use of medications for cognitive enhancement within 3 months of baseline.

- Significant neurologic disease other than AD that may affect cognition.

NCT00151398
Pfizer
Completed
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

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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 SummaryThe 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 DescriptionNot 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 DateMarch 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth 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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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