The purpose of the study 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.

Condition	Intervention	Phase
Alzheimer''''s Disease Outpatients Cholinesterase Inhibitors	Drug: Lecozotan SR (SRA-333)	Phase II Phase III

Further study details as provided by Wyeth:

Primary Outcomes: All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
Secondary Outcomes: Score change from baseline to 24 weeks on functional and behavioral scales
Expected Total Enrollment:  312

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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:

• no significant neurological disease other than AD
• no diagnosis of major depression
• no history of stroke or other heart disease

Please refer to this study by ClinicalTrials.gov identifier  NCT00277810

Trial Manager       clinicaltrialinfo@wyeth.com

Arizona
      Phoenix,  Arizona,  85013,  United States
      Tucson,  Arizona,  85741,  United States
California
      La Jolla,  California,  92037,  United States
      Fresno,  California,  93720,  United States
      Orange,  California,  92868,  United States
Florida
      Delray Beach,  Florida,  33445,  United States
      Hialeah,  Florida,  33016,  United States
      Orlando,  Florida,  32806,  United States
      Miami,  Florida,  33176,  United States
      Jacksonville,  Florida,  33216,  United States
      Ft. Myers,  Florida,  33916,  United States
      Tampa,  Florida,  33617,  United States
      Sarasota,  Florida,  34239,  United States
      West Palm Beach,  Florida,  33407,  United States
      Miami Beach,  Florida,  33154,  United States
      Ft. Lauderdale,  Florida,  33321,  United States
Missouri
      St. Louis,  Missouri,  63104,  United States
New Jersey
      Manchester Twp.,  New Jersey,  08759,  United States
New York
      Lawrence,  New York,  11559,  United States
      Albany,  New York,  12208,  United States
North Carolina
      Winston Salem,  North Carolina,  27103,  United States
Ohio
      Columbus,  Ohio,  43210,  United States
Oklahoma
      Tulsa,  Oklahoma,  74104,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19107,  United States
Tennessee
      Memphis,  Tennessee,  38119,  United States
Texas
      Houston,  Texas,  77030,  United States
Vermont
      Bennington,  Vermont,  05201,  United States
Argentina
      Cervino,  3356,  Argentina
      Nueva York,  3952,  Argentina
      Calle Adolfo Alsina,  2184,  Argentina
      Av. Belgrano,  2945,  Argentina
      Gascon,  Argentina
      Larrea,  1035,  Argentina
      Galvan,  4102,  Argentina
      Pilar,  950,  Argentina
      Buenos Aires,  Argentina
Australia
      Hornsby,  NSW 2077,  Australia
      Victoria,  3081,  Australia
      Adelaide,  5000,  Australia
      Randwick,  2031,  Australia
Finland
      Kuopio,  FIN 70211,  Finland
      Joensuu,  80100,  Finland
      Helsinki,  FIN-00029,  Finland
France
      Montpellier,  34295,  France
      Nice,  06002,  France
      Toulouse,  31300,  France
      Bordeaux,  33076,  France
Italy
      Bari,  Italy
      Roma,  010168,  Italy
Poland
      Gdansk - Wrzeszcz,  00-282,  Poland
      Gdansk,  80-305,  Poland
      Lodz,  92-216,  Poland
South Africa
      Bloemfontein,  9301,  South Africa
      Cape Town,  7500,  South Africa
Spain
      Barcelona,  170,  Spain
      Barcelona,  08014,  Spain
      Madrid,  28046,  Spain
      Barcelona,  08003,  Spain
      Barcelona,  08025,  Spain
      Madrid,  28040,  Spain
United Kingdom
      Leeds,  LS2 9LT,  United Kingdom
      Southampton,  SO30 3JB,  United Kingdom
      Belfast,  BT9 7BL,  United Kingdom

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   
Trial Manager,  Principal Investigator,  For United Kingdom, ukmedinfo@wyeth.com   
Trial Manager,  Principal Investigator,  For France, infomedfrance@wyeth.com   
Trial Manager,  Principal Investigator,  For Poland, WPWZMED@wyeth.com   
Trial Manager,  Principal Investigator,  For Spain, infomed@wyeth.com   
Trial Manager,  Principal Investigator,  For Argentina, scheima@wyeth.com or rendop@wyeth.com   
Trial Manager,  Principal Investigator,  For Italy, decresg@wyeth.com   
Trial Manager,  Principal Investigator,  For South Africa, AZFinfo@wyeth.com   
Trial Manager,  Principal Investigator,  For Australia, medinfo@wyeth.com   
Trial Manager,  Principal Investigator,  For Finland, MedInfoNord@wyeth.com   

Study ID Numbers:  3098B1-203, 3098B1-204
Last Updated:  January 13, 2006
Record first received:  January 12, 2006
ClinicalTrials.gov Identifier:  NCT00277810
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency; Spain: Ministry of Health; France: Ministry of Health; Finland: Ethics Committee; Poland: Ministry of Health; South Africa: Medicines Control Council; Italy: Ethics Committee; United Kingdom: National Health Service; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2006-01-17