Not Signed In -
Bupropion SR |
Budeprion SR; Wellbutrin SR |
Clinical Trial: Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer''s Disease (AD)
This study is not yet open for patient recruitment.
Verified by Wyeth September 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer''''s Disease | Drug: lecozotan SR | Phase II |
MedlinePlus related topics: Alzheimer''''s Caregivers; Alzheimer''''s Disease
Genetics Home Reference related topics: Alzheimer disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Further Study Details:
Primary Outcomes: The primary endpoints will be the change from baseline in ADAS-Cog total score; and ADCS-CGIC total score at week 12.
Secondary Outcomes: Secondary efficacy outcome variables include additional cognitive, functional,and; behavioral measures.
Expected Total Enrollment: 355
Secondary Outcomes: Secondary efficacy outcome variables include additional cognitive, functional,and; behavioral measures.
Expected Total Enrollment: 355
Study start: September 2005
Eligibility
Ages Eligible for Study: 50 Years and above, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00151398
Trial Manager clinicaltrialinfo@wyeth.com
Arizona
Phoenix, Arizona, 85013, United States
see Central Contact
Tucson, Arizona, 85741, United States
see Central Contact
California
La Jolla, California, 92037, United States
see Central Contact
Fresno, California, 93720, United States
see Central Contact
Orange, California, 92868, United States
see Central Contact
Florida
Delray Beach, Florida, 33445, United States
see Central Contact
Hialeah, Florida, 33016, United States
see Central Contact
Orlando, Florida, 32806, United States
see Central Contact
Miami, Florida, 33176, United States
see Central Contact
Jacksonville, Florida, 33216, United States
see Central Contact
Boca Raton, Florida, 33486, United States
see Central Contact
Ft. Myers, Florida, 33916, United States
see Central Contact
Tampa, Florida, 33617, United States
see Central Contact
Sarasota, Florida, 34239, United States
see Central Contact
West Palm Beach, Florida, 33407, United States
see Central Contact
Miami Beach, Florida, 33154, United States
see Central Contact
Ft. Lauderdale, Florida, 33321, United States
see Central Contact
Missouri
St. Louis, Missouri, 63104, United States
see Central Contact
New Jersey
Manchester Twp., New Jersey, 08759, United States
see Central Contact
New York
Lawrence, New York, 11559, United States
see Central Contact
Albany, New York, 12208, United States
see Central Contact
North Carolina
Winston Salem, North Carolina, 27103, United States
see Central Contact
Ohio
Columbus, Ohio, 43210, United States
see Central Contact
Oklahoma
Tulsa, Oklahoma, 74104, United States
see Central Contact
Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
see Central Contact
Tennessee
Memphis, Tennessee, 38119, United States
see Central Contact
Texas
Houston, Texas, 77030, United States
see Central Contact
Vermont
Bennington, Vermont, 05201, United States
see Central Contact
Argentina
Cervino, 3356, Argentina
see Central Contact
Nueva York, 3952, Argentina
see Central Contact
Calle Adolfo Alsina, 2184, Argentina
see Central Contact
Av. Belgrano, 2945, Argentina
see Central Contact
Gascon, Argentina
see Central Contact
Larrea, 1035, Argentina
see Central Contact
Galvan, 4102, Argentina
see Central Contact
Pilar, Argentina
see Central Contact
Australia, New South Wales
Hornsby, New South Wales, 2077, Australia
see Central Contact
Australia, Victoria
Heidelberg Heights, Victoria, 3081, Australia
see Central Contact
Canada, Alberta
Medicine Hat, Alberta, T1A 4C2, Canada
see Central Contact
Edmonton, Alberta, T5G 0B7, Canada
see Central Contact
Canada, New Brunswick
Moncton, New Brunswick, E1C 4B7, Canada
see Central Contact
Canada, Ontario
Ottawa, Ontario, K1N 5C8, Canada
see Central Contact
Canada, Quebec
Montreal, Quebec, Canada
see Central Contact
Canada, Saskatchewan
Regina, Saskatchewan, S4T 1A5, Canada
see Central Contact
South Africa, Bloemfontein
Westdene, Bloemfontein, 9301, South Africa
see Central Contact
South Africa, Cape Town
Observatory, Cape Town, 7925, South Africa
see Central Contact
Panorama, Cape Town, 7500, South Africa
see Central Contact
South Africa, Johannesburg
Florida, Johannesburg, 1709, South Africa
see Central Contact
South Africa, Western Cape
Bellville, Western Cape, 7530, South Africa
see Central Contact
Study chairs or principal investigators
Medical Monitor, Study Director, Wyeth Research
More Information
Study ID Numbers: 3098B1-201, 3098B1-202
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00151398
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00151398
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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