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Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

Last updated on December 7, 2019

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 Alzheimer`s disease

- Current use of cholinesterase inhibitor

- Able to give signed and dated informed consent and lives with appropriate caregiver
at home or in community dwelling with caregiver accompanying patient to all visits
and visiting patient at least daily for duration of the study

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

- Significant neurological disease other than AD

- Diagnosis of major depression

- History of stroke or other heart disease

NCT00277810
Pfizer
Completed
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Official Title  ICMJE A 6-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 Treated With a Cholinesterase Inhibitor
Brief SummaryThe purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extesnion to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: B
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: C
    Intervention: Drug: lecozotan SR (SRA-333)
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 21, 2007)
250
Original Enrollment  ICMJE
 (submitted: January 12, 2006)
312
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion DateJune 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer`s disease
  • Current use of cholinesterase inhibitor
  • Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Diagnosis of major depression
  • History of stroke or other heart disease
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,   Finland,   France,   Italy,   Poland,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277810
Other Study ID Numbers  ICMJE 3098B1-203, 3098B1-204
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
Principal Investigator:Trial ManagerFor United Kingdom, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Principal Investigator:Trial ManagerFor Argentina, [email protected] or [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Finland, [email protected]
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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