Clinical trial NCT00151398: Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 229
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
timeFrame: weeks 12, 14, 26 and 40.
Secondary outcomes:
measure: Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
timeFrame: weeks 12, 14, 26 and 40.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Orange
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Saint Louis
country: United States
state: Missouri
city: Long Branch
country: United States
state: New Jersey
city: Manchester Twp.
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Lawrence
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Av. Belgrano
country: Argentina
city: Calle Adolfo Alsina
country: Argentina
city: Cervino
country: Argentina
city: Galvan
country: Argentina
city: Gascon
country: Argentina
city: Larrea
country: Argentina
city: Nueva York
country: Argentina
city: Pilar
country: Argentina
city: Hornsby
country: Australia
state: New South Wales
city: Heidelberg Heights
country: Australia
state: Victoria
city: Edmonton
country: Canada
state: Alberta
city: Medicine Hat
country: Canada
state: Alberta
city: Moncton
country: Canada
state: New Brunswick
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Westdene
country: South Africa
state: Bloemfontein
city: Observatory
country: South Africa
state: Cape Town
city: Panorama
country: South Africa
state: Cape Town
city: Florida
country: South Africa
state: Johannesburg
city: Bellville
country: South Africa
state: Western Cape
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: