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

Last updated on August 9, 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 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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Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
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
The 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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
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
  • Experimental: A
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: B
    Intervention: Drug: lecozotan SR (SRA-333)
  • Experimental: C
    Intervention: Drug: lecozotan SR (SRA-333)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
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,   Finland,   France,   Italy,   Poland,   South Africa,   Spain,   United Kingdom,   United States
 
 
NCT00277810
3098B1-203, 3098B1-204
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For United Kingdom, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Principal Investigator: Trial Manager For Argentina, [email protected] or [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For Finland, [email protected]
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.

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1-800-718-1021

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