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Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00277810
First received: January 12, 2006
Last updated: February 14, 2013
Last verified: July 2008
  Purpose

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).


Condition Intervention Phase
Alzheimer Disease
Drug: lecozotan SR (SRA-333)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales [ Time Frame: 6 mo extension study: week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Score change from baseline to 24 weeks on functional and behavioral scales [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extesnion to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
Experimental: B Drug: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extesnion to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
Experimental: C Drug: lecozotan SR (SRA-333)
one of 3 doses of lecozotan sr dose for 6 months as an extesnion to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277810

  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
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, 33216
Miami, Florida, United States, 33176
Miami Beach, Florida, United States, 33154
Orlando, Florida, United States, 32806
S. Miami, Florida, United States, 33143
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
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
Buenos Aires, Argentina
Calle Adolfo Alsina, Argentina, 2184
Cervino, Argentina, 3356
Galvan, Argentina, 4102
Gascon, Argentina, 450
Larrea, Argentina, 1035
Nueva York, Argentina, 3952
Pilar, Argentina, 950
Australia
Adelaide, Australia, 5000
East Gosford, Australia, 2250
Hornsby, Australia, 2077
Randwick, Australia, 2031
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, H4H 1R3
Finland
Helsinki, Finland, 00120
Joensuu, Finland, 80100
Kuopio, Finland, 70211
France
Bordeaux, France, 33076
Montpellier, France, 34295
Nice, France, 06002
Toulouse, France, 31300
Italy
Roma, Italy, 00168
Roma, Italy, 00143
Poland
Gdansk - Wrzeszcz, Poland, 00-282
Krakow, Poland, 31-530
Krakow, Poland, 30-393
Lodz, Poland, 92-216
Lublin, Poland, 20-022
Sopot, Poland, 81-824
Szczecin, Poland, 70-356
South Africa
Bloemfontein, South Africa, 9301
Cape Town, South Africa, 7500
Johannesburg, South Africa, 2197
Somerset West, South Africa, 7130
Spain
Barcelona, Spain, 08025
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Barcelona, Spain, 08014
Madrid, Spain, 28046
Madrid, Spain, 28040
United Kingdom
Belfast, United Kingdom, BT9 7BL
Glasgow, United Kingdom, G20 0XA
Sheffield, United Kingdom, S35 8QS
Southampton, United Kingdom, SO30 3JB
Swindon, United Kingdom, SN1 4JU
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
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Principal Investigator: Trial Manager For Argentina, scheima@wyeth.com or rendop@wyeth.com
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For South Africa, AZFinfo@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For Finland, MedInfoNord@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00277810     History of Changes
Other Study ID Numbers: 3098B1-203, 3098B1-204
Study First Received: January 12, 2006
Last Updated: February 14, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
European Union: European Medicines Agency
Finland: Ethics Committee
France: Ministry of Health
Italy: Ethics Committee
Poland: Ministry of Health
South Africa: Medicines Control Council
Spain: Ministry of Health
United Kingdom: National Health Service
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer's Disease
Cholinesterase Inhibitors
Outpatients

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Cholinesterase Inhibitors
Cholinergic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014