Clinical trial NCT00277810: Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Cholinesterase Inhibitors
Outpatients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 250
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 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).


Eligibility criteria: 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

Primary outcomes:
measure: All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
timeFrame: 6 mo extension study: week 24
Secondary outcomes:
measure: Score change from baseline to 24 weeks on functional and behavioral scales
timeFrame: week 24
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: 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: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
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: 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: Buenos Aires
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: Adelaide
country: Australia
city: East Gosford
country: Australia
city: Hornsby
country: Australia
city: Randwick
country: Australia
city: Victoria
country: Australia
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: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Kuopio
country: Finland
city: Bordeaux
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Toulouse
country: France
city: Roma
country: Italy
city: Roma
country: Italy
city: Gdansk - Wrzeszcz
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Somerset West
country: South Africa
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Belfast
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swindon
country: United Kingdom
Study officials:
References: