Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)
25 de setembro de 2019 atualizado por: Eli Lilly and Company
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1457
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 12203
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Hamburg, Alemanha, 22307
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Hannover, Alemanha, 30559
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Mannheim, Alemanha, 68165
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Munich, Alemanha, D-81675
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Regensburg, Alemanha, 93042
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Buenos Aires, Argentina, CBA 1419
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Ciudad Automona De Buenos Aire, Argentina, C1111AAL
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Cordoba, Argentina, X5004AOA
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Mendoza, Argentina, 5500
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Rosario, Argentina, S2000BZL
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Santa Fe, Argentina, S3000FWO
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New South Wales
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Gosford, New South Wales, Austrália, 2250
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Kogarah, New South Wales, Austrália, 2217
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Queensland
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Chermside, Queensland, Austrália, 4032
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Toowoomba, Queensland, Austrália, 4650
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Victoria
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Box Hill, Victoria, Austrália, 3128
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Glen Iris, Victoria, Austrália, 3146
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Heidelberg Heights, Victoria, Austrália, 3081
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Melbourne, Victoria, Austrália, 3004
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Western Australia
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Subiaco, Western Australia, Austrália, 6008
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Curitiba, Brasil, 80060-900
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Itapira, Brasil, 13970-905
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Porto Alegre, Brasil, 90110-270
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Rio De Janeiro, Brasil, 22271-100
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São Paulo, Brasil, 04024-002
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Alberta
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Medicine Hat, Alberta, Canadá, T1B4E7
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y3G5
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Penticton, British Columbia, Canadá, V2A 5C8
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Ontario
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Ottawa, Ontario, Canadá, K1N 5C8
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Toronto, Ontario, Canadá, M6M 3Z5
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Quebec
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Greenfield Park, Quebec, Canadá, J4V 2J2
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Sherbrooke, Quebec, Canadá, J1H1Z1
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Barcelona, Espanha, 08014
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Getafe, Espanha, 28905
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Madrid, Espanha, 28006
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Plasencia, Espanha, 10600
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Terrassa, Espanha, 08221
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
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Sun City, Arizona, Estados Unidos, 85351
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Tucson, Arizona, Estados Unidos, 85718
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72211
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California
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Carson, California, Estados Unidos, 90746
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Laguna Hills, California, Estados Unidos, 92653
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Lomita, California, Estados Unidos, 90717
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Los Angeles, California, Estados Unidos, 90073
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Oxnard, California, Estados Unidos, 93030
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San Diego, California, Estados Unidos, 92103
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San Francisco, California, Estados Unidos, 94109
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Santa Ana, California, Estados Unidos, 92705
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Santa Monica, California, Estados Unidos, 90404
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Colorado
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Denver, Colorado, Estados Unidos, 80239
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Connecticut
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Fairfield, Connecticut, Estados Unidos, 06824
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Hamden, Connecticut, Estados Unidos, 06518
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New Haven, Connecticut, Estados Unidos, 06510
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Norwalk, Connecticut, Estados Unidos, 06851
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Delaware
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Newark, Delaware, Estados Unidos, 19713
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20057
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Florida
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Boca Raton, Florida, Estados Unidos, 33431
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Fort Myers, Florida, Estados Unidos, 33912
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Hollywood, Florida, Estados Unidos, 33021
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Miami, Florida, Estados Unidos, 33137
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Miami Springs, Florida, Estados Unidos, 33166
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Orange City, Florida, Estados Unidos, 32763
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Orlando, Florida, Estados Unidos, 32806
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Sunrise, Florida, Estados Unidos, 33351
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Tampa, Florida, Estados Unidos, 33613
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Georgia
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Atlanta, Georgia, Estados Unidos, 30341
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Canton, Georgia, Estados Unidos, 30114
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Decatur, Georgia, Estados Unidos, 30033
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
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Maryland
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Baltimore, Maryland, Estados Unidos, 21285
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Rockville, Maryland, Estados Unidos, 20852
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Massachusetts
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Belmont, Massachusetts, Estados Unidos, 02478
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Michigan
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Traverse City, Michigan, Estados Unidos, 49684
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Missouri
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Creve Coeur, Missouri, Estados Unidos, 63141
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
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New York
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Albany, New York, Estados Unidos, 12205
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Amherst, New York, Estados Unidos, 14226
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Brooklyn, New York, Estados Unidos, 11235
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Latham, New York, Estados Unidos, 12210
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New York, New York, Estados Unidos, 10032
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Staten Island, New York, Estados Unidos, 10312
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607
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Winston-Salem, North Carolina, Estados Unidos, 27103
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
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Toledo, Ohio, Estados Unidos, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73116
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
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Portland, Oregon, Estados Unidos, 97210
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
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Greer, South Carolina, Estados Unidos, 29650
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
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Utah
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Salt Lake City, Utah, Estados Unidos, 84108
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Vermont
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Bennington, Vermont, Estados Unidos, 05201
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Burlington, Vermont, Estados Unidos, 05401
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
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Roanoke, Virginia, Estados Unidos, 24018
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Washington
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Seattle, Washington, Estados Unidos, 98108
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Chelyabinsk, Federação Russa, 454091
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Saint Petersburg, Federação Russa, 190021
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Paris, França, 75475
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Rennes, França, 35000
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Strasbourg, França, 67091
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Toulouse, França, 31300
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Baggiovara, Itália, 41100
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Biella, Itália, 13900
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Chieti, Itália, 66013
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Genova, Itália, 16128
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Lido Di Camaiore, Itália, 55043
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Milano, Itália, 20132
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Rome, Itália, 00186
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Aichi, Japão, 474-8511
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Ehime, Japão, 791-0295
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Fukuoka, Japão, 816-0864
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Hiroshima, Japão, 720-0825
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Hyogo, Japão, 514-8507
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Kanagawa, Japão, 247-8533
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Kyoto, Japão, 607-8062
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Osaka, Japão, 545-8586
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Shizuoka, Japão, 424-0911
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Tokyo, Japão, 187-8551
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Bydgoszcz, Polônia, 85-796
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Gliwice, Polônia, 44-100
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Katowice, Polônia, 40-588
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Krakow, Polônia, 31-530
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Lublin, Polônia, 20-954
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Warsaw, Polônia, 01-211
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E Susx
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Uckfield, E Susx, Reino Unido, TN225AW
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Glasgow
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Scotland, Glasgow, Reino Unido, G20 0XA
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Greater London
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London, Greater London, Reino Unido, N195NX
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London
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Camberwell, London, Reino Unido, SE5 8AF
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Incheon, Republica da Coréia, 400-711
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Seongnam-Si, Republica da Coréia, 463-707
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Seoul, Republica da Coréia, 143-729
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Suwon-Si, Republica da Coréia, 443-721
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Jönköping, Suécia, 551 85
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Kalmar, Suécia, 39185
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Lund, Suécia, 22241
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Molndal, Suécia, 43135
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Umea, Suécia, 901 85
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Guishan, Taiwan, 33305
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Niaosong, Taiwan, 833
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Taipei, Taiwan, 112
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
55 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
- Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
- Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
- Must have good vein access to administer infusions
- Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo
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Participants were from feeder studies (LZAM or LZAN).
Placebo administered intravenously every 4 weeks through Week 80.
|
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Experimental: Solanezumab
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400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Prazo: Baseline through Week 104
|
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively.
In addition, the number of participants with 1 or more serious AEs is summarized cumulatively.
A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through Week 104
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
Prazo: Baseline, Week 104
|
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures.
A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90.
Higher scores indicate greater disease severity.
Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Prazo: Baseline, Week 104
|
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver.
It measures performance of basic and instrumental activities of daily living by participants.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Prazo: Baseline, Week 104
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
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Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
Prazo: Baseline, Week 104
|
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia.
Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe).
If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain.
NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144.
Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
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Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
Prazo: Baseline, Week 104
|
The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver.
It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision.
Scores range from 0 to 24 hours.
Higher values indicate greater resource use.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
Prazo: Baseline, Week 104
|
EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state.
Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems).
These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm.
EQ-5D US Population-Based Index Scores range from -0.11 to 1.0.
A score of 1.0 indicated perfect health.
The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state).
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Prazo: Baseline, Week 104
|
The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant.
The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole.
The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent).
QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52.
Higher scores denote a better quality of life.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
Prazo: Baseline, Week 104
|
The MMSE is an instrument used to assess a participant's cognitive function.
The instrument is divided into 2 sections.
The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment).
The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment).
The range for MMSE Total Score is 0 to 30.
Lower scores indicate more impairment.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels
Prazo: Baseline, Week 52
|
Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay.
The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 52
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Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
Prazo: Baseline, Week 104
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The vMRI assessment of right and left hippocampal volume is reported.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
Prazo: Baseline, Week 104
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The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis.
The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 104
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Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease
Prazo: Baseline, Week 104
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Florbetapir PET imaging was used to test for change from baseline.
The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested.
The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated.
The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.
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Baseline, Week 104
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2010
Conclusão Primária (Real)
1 de julho de 2014
Conclusão do estudo (Real)
1 de fevereiro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
19 de maio de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de maio de 2010
Primeira postagem (Estimativa)
21 de maio de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11935 (Identificador de registro: DAIDS ES Registry Number)
- H8A-MC-LZAO (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Prazo de Compartilhamento de IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .