Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
NCT ID: NCT00151398
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2005-10-06
2008-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
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.
B
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.
C
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.
D
Donepezil
10 mg donepezil QD dosed up to 40 weeks
Interventions
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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.
Donepezil
10 mg donepezil QD dosed up to 40 weeks
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent. Patient' s caregiver must consent to participate in the study.
Exclusion Criteria
* Significant neurologic disease other than AD that may affect cognition.
50 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Costa Mesa, California, United States
Fresno, California, United States
La Jolla, California, United States
Orange, California, United States
Boca Raton, Florida, United States
Delray Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
St Louis, Missouri, United States
Long Branch, New Jersey, United States
Manchester Twp., New Jersey, United States
Albany, New York, United States
Cedarhurst, New York, United States
Lawrence, New York, United States
Staten Island, New York, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
East Providence, Rhode Island, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Bennington, Vermont, United States
Av. Belgrano, , Argentina
Calle Adolfo Alsina, , Argentina
Cervino, , Argentina
Gascon, , Argentina
Larrea, , Argentina
Nueva York, , Argentina
Pilar, , Argentina
Puerto Galván, , Argentina
Hornsby, New South Wales, Australia
Heidelberg Heights, Victoria, Australia
Edmonton, Alberta, Canada
Medicine Hat, Alberta, Canada
Moncton, New Brunswick, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Westdene, Bloemfontein, South Africa
Observatory, Cape Town, South Africa
Panorama, Cape Town, South Africa
Florida, Johannesburg, South Africa
Bellville, Western Cape, South Africa
Countries
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Other Identifiers
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B343-1057, B343-1058
Identifier Type: OTHER
Identifier Source: secondary_id
3098B1-201, 3098B1-202
Identifier Type: -
Identifier Source: org_study_id
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