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Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT00151398
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: lecozotan SR Drug: Donepezil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008


Arm Intervention/treatment
Experimental: A Drug: 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.


Experimental: B Drug: 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.


Experimental: C Drug: 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.


Active Comparator: D Drug: Donepezil
10 mg donepezil QD dosed up to 40 weeks




Primary Outcome Measures :
  1. The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. [ Time Frame: weeks 12, 14, 26 and 40. ]

Secondary Outcome Measures :
  1. Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. [ Time Frame: weeks 12, 14, 26 and 40. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151398


  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85013
Tucson, Arizona, United States, 85741
United States, California
Costa Mesa, California, United States, 92626
Fresno, California, United States, 93720
La Jolla, California, United States, 92037
Orange, California, United States, 92868
United States, Florida
Boca Raton, Florida, United States, 33486
Delray Beach, Florida, United States, 33445
Ft. Lauderdale, Florida, United States, 33321
Ft. Myers, Florida, United States, 33916
Hallandale, Florida, United States, 33009
Hialeah, Florida, United States, 33016
Jacksonville, Florida, United States, 32216
Miami Beach, Florida, United States, 33154
Miami, Florida, United States, 33173
Miami, Florida, United States, 33176
Orlando, Florida, United States, 32806
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33617
West Palm Beach, Florida, United States, 33407
United States, Missouri
St. Louis, Missouri, United States, 63104
United States, New Jersey
Long Branch, New Jersey, United States, 07740
Manchester Twp., New Jersey, United States, 08759
United States, New York
Albany, New York, United States, 12208
Cedarhurst, New York, United States, 11516
Lawrence, New York, United States, 11559
Staten Island, New York, United States, 10312
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oklahoma
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Houston, Texas, United States, 77030
United States, Vermont
Bennington, Vermont, United States, 05201
Argentina
Av. Belgrano, Argentina, 2945
Calle Adolfo Alsina, Argentina, 2184
Cervino, Argentina, 3356
Galvan, Argentina, 4102
Gascon, Argentina, 450
Larrea, Argentina, 1035
Nueva York, Argentina, 3952
Pilar, Argentina
Australia, New South Wales
Hornsby, New South Wales, Australia, 2077
Australia, Victoria
Heidelberg Heights, Victoria, Australia, 3081
Canada, Alberta
Edmonton, Alberta, Canada, T5G 0B7
Medicine Hat, Alberta, Canada, T1A 4C2
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 4B7
Canada, Ontario
Ottawa, Ontario, Canada, K1N 5C8
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 1A5
South Africa
Westdene, Bloemfontein, South Africa, 9301
Observatory, Cape Town, South Africa, 7925
Panorama, Cape Town, South Africa, 7500
Florida, Johannesburg, South Africa, 1709
Bellville, Western Cape, South Africa, 7530
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00151398     History of Changes
Other Study ID Numbers: 3098B1-201, 3098B1-202
B343-1057, B343-1058 ( Other Identifier: Pfizer )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: July 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents