Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
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.
2 other identifiers
interventional
229
5 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Oct 2005
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Start
First participant enrolled
October 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2008
CompletedMay 6, 2022
April 1, 2022
2.4 years
September 6, 2005
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
weeks 12, 14, 26 and 40.
Secondary Outcomes (1)
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
weeks 12, 14, 26 and 40.
Study Arms (4)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Use of medications for cognitive enhancement within 3 months of baseline.
- Significant neurologic disease other than AD that may affect cognition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
Costa Mesa, California, 92626, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Delray Beach, Florida, 33445, United States
Unknown Facility
Fort Lauderdale, Florida, 33321, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
Hallandale, Florida, 33009, United States
Unknown Facility
Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33176, United States
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Miami Beach, Florida, 33154, United States
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Orlando, Florida, 32806, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33617, United States
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West Palm Beach, Florida, 33407, United States
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St Louis, Missouri, 63104, United States
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Long Branch, New Jersey, 07740, United States
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Manchester Twp., New Jersey, 08759, United States
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Albany, New York, 12208, United States
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Cedarhurst, New York, 11516, United States
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Lawrence, New York, 11559, United States
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Staten Island, New York, 10312, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43210, United States
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Tulsa, Oklahoma, 74104, United States
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Philadelphia, Pennsylvania, 19107, United States
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East Providence, Rhode Island, 02914, United States
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Memphis, Tennessee, 38119, United States
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Houston, Texas, 77030, United States
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Bennington, Vermont, 05201, United States
Unknown Facility
Av. Belgrano, 2945, Argentina
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Calle Adolfo Alsina, 2184, Argentina
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Cervino, 3356, Argentina
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Gascon, 450, Argentina
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Larrea, 1035, Argentina
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Nueva York, 3952, Argentina
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Pilar, Argentina
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Puerto Galván, 4102, Argentina
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Hornsby, New South Wales, 2077, Australia
Unknown Facility
Heidelberg Heights, Victoria, 3081, Australia
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Edmonton, Alberta, T5G 0B7, Canada
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Medicine Hat, Alberta, T1A 4C2, Canada
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Moncton, New Brunswick, E1C 4B7, Canada
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Ottawa, Ontario, K1N 5C8, Canada
Unknown Facility
Montreal, Quebec, Canada
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Regina, Saskatchewan, S4T 1A5, Canada
Unknown Facility
Westdene, Bloemfontein, 9301, South Africa
Unknown Facility
Observatory, Cape Town, 7925, South Africa
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Panorama, Cape Town, 7500, South Africa
Unknown Facility
Florida, Johannesburg, 1709, South Africa
Unknown Facility
Bellville, Western Cape, 7530, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
October 6, 2005
Primary Completion
March 15, 2008
Study Completion
March 15, 2008
Last Updated
May 6, 2022
Record last verified: 2022-04