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

Last updated on May 11, 2018

FOR MORE INFORMATION
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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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
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, Senior)
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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