Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277810
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Hide Study LocationsLocations
| 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, 08036 | |
| Barcelona, Spain, 08014 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08025 | |
| 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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013