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Efeito de LY2062430 na Progressão da Doença de Alzheimer (EXPEDITION2)

11 de dezembro de 2012 atualizado por: Eli Lilly and Company

Efeito da imunização passiva na progressão da doença de Alzheimer: LY2062430 versus placebo

A doença de Alzheimer (DA) é um distúrbio degenerativo do cérebro relacionado à idade, caracterizado pelo declínio progressivo da função cognitiva e da capacidade de realizar atividades da vida diária, podendo levar à morte devido às complicações da doença. Acredita-se que a DA seja causada por um excesso de A-Beta amilóide, uma proteína pegajosa no cérebro que forma placas amilóides. Pode-se esperar que os tratamentos que retardam a síntese ou deposição de amilóide A-Beta, ou que aumentam a depuração, retardem a progressão da DA.

LY2062430 (solanezumab) é um anticorpo monoclonal humanizado anti-A Beta peptídeo imunoglobulina G-1 (IgG1) que está sendo desenvolvido para o tratamento da DA. A principal hipótese que está sendo testada é que o LY2062430 retardará o declínio cognitivo e funcional na DA em comparação com o placebo. A participação de cada paciente durará aproximadamente 19 meses. Os pacientes que tomam medicamentos aprovados para AD podem participar deste estudo e continuar tomando esses medicamentos durante o estudo.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1040

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

  • Alemanha
      • Berlin, Alemanha, D-12200
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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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      • Marburg, Alemanha, 35033
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      • Munchen, Alemanha, BY 80336
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      • München, Alemanha, D-81675
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      • Regensburg, Alemanha, 93042
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  • Austrália
    • New South Wales
      • Bankstown, New South Wales, Austrália, 2200
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      • Darlinghurst, New South Wales, Austrália, 2010
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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
      • Chermside, Queensland, Austrália, 4032
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      • Toowoomba, Queensland, Austrália, 4650
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    • Victoria
      • 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
      • Subiaco, Western Australia, Austrália, 6008
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  • Espanha
      • Barcelona, Espanha, 08014
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      • Getafe, Espanha, 28905
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      • Madrid, Espanha, 28034
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      • Plasencia, Espanha, 10600
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      • Terrassa, Espanha, 0821
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  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85741
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    • California
      • Los Angeles, California, Estados Unidos, 90033
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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 Monica, California, Estados Unidos, 90404
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    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Miami, Florida, Estados Unidos, 33137
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tampa Bay, Florida, Estados Unidos, 33613
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Mississippi
      • Hattiesburg, Mississippi, Estados Unidos, 39401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kansas City, Missouri, Estados Unidos, 64114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Amherst, New York, Estados Unidos, 14226
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Staten Island, New York, Estados Unidos, 10312
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Portland, Oregon, Estados Unidos, 97210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Seattle, Washington, Estados Unidos, 98108
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Federação Russa
      • Chelyabinsk, Federação Russa, 454091
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ekaterinburg, Federação Russa, 620030
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rostov-On-Don, Federação Russa, 344010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg, Federação Russa, 190021
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • França
      • Aix En Provence, França, 13100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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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  • Itália
      • Biella, Itália, 13900
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      • Boggiovara, Itália, 41100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cassino, Itália, 03043
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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, 00179
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  • Japão
      • Ehime, Japão, 791-0295
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      • Fukuoka, Japão, 816-0864
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      • Hyogo, Japão, 514-8507
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      • Kanagawa, Japão, 247-0072
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      • Kyoto, Japão, 606-0851
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      • Osaka, Japão, 558-0056
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      • Shizuoka, Japão, 424-0911
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      • Tokyo, Japão, 173
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  • Polônia
      • Bialystok, Polônia, 15-617
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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, 20-090
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      • Warsaw, Polônia, 02-777
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  • Reino Unido
    • E Susx
      • Uckfield, E Susx, Reino Unido, TN225AW
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    • Glasgow
      • Scotland, Glasgow, Reino Unido, G20 0XA
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    • Greater London
      • London, Greater London, Reino Unido, N195NX
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    • London
      • Camberwell, London, Reino Unido, SE5 8AF
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    • Syorks
      • Sheffield, Syorks, Reino Unido, S57JT
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    • Wiltshire
      • Swindon, Wiltshire, Reino Unido, SN3 6BW
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  • Republica da Coréia
      • 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, Republica da Coréia, 443-721
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Suécia
      • Joenkoeping, Suécia, 551 85
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kalmar, Suécia, 39185
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lund, Suécia, 22241
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      • Malmo, Suécia, 20502
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Molndal, Suécia, 43135
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stockholm, Suécia, 14186
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Umea, Suécia, 901 85
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Niao Sung Hsiang, Taiwan, 83301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung, Taiwan, 404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taipei, Taiwan, 112
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tao-Yuan, Taiwan, 333
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yung-Kang, Tainan, Taiwan, 710
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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

Critério de inclusão:

  • Atende aos critérios para Doença de Alzheimer (DA) leve a moderada com pontuação de 16 a 26 no Mini-Exame do Estado Mental na triagem
  • Pontuação da Escala de Isquemia de Hachinski modificada menor ou igual a 4
  • Pontuação da Escala de Depressão Geriátrica menor ou igual a 6
  • Uma ressonância magnética (MRI) ou tomografia computadorizada (TC) nos últimos 2 anos sem achados inconsistentes com o diagnóstico de DA
  • Se estiver recebendo tratamento concomitante para DA, deve estar tomando o medicamento por pelo menos 4 meses em uma dose estável por pelo menos 2 meses antes da randomização

Critério de exclusão:

  • Tem doença(s) grave(s) ou instável(is)
  • Não tem um cuidador confiável que esteja em contato frequente com o paciente (pelo menos 10 horas por semana)
  • Atende aos critérios do National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) para demência vascular
  • Não tem um bom acesso venoso, de modo que a administração intravenosa (IV) da droga seria difícil
  • Teve múltiplos episódios de traumatismo craniano ou história nos últimos 5 anos de uma doença infecciosa grave que afetou o cérebro
  • Tem alergia a anticorpos monoclonais humanizados
  • Abuso crônico de álcool e/ou drogas nos últimos 5 anos
  • Tem alguma contra-indicação para estudos de ressonância magnética
  • Requer tratamento com outro anticorpo monoclonal

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: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Medicamento: Placebo
por via intravenosa (IV) a cada 4 semanas por 80 semanas
Experimental: LY2062430
Medicamento: LY2062430
400 mg por via intravenosa (IV) a cada 4 semanas por 80 semanas
Outros nomes:
  • Um anticorpo beta
  • Solanezumabe (*nome adotado pela USAN, INN pendente)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Mudança da linha de base para a semana 80 na escala de avaliação da doença de Alzheimer - escala de 14 itens da subpontuação cognitiva (ADAS-Cog14)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80

Medidas de resultados secundários

Medida de resultado
Prazo
Mudança da linha de base para a semana 80 na classificação clínica de demência - pontuação da soma das caixas (CDR-SB)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na pontuação do inventário neuropsiquiátrico (NPI)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na ressonância magnética volumétrica (vMRI)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na pontuação do mini-exame do estado mental (MMSE)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na utilização de recursos na demência - pontuação leve (RUD-Lite)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na pontuação da escala de qualidade de vida relacionada à saúde EuroQol 5-Dimensional versão proxy (EQ-5D Proxy)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na pontuação de qualidade de vida na doença de Alzheimer (QoL-AD)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 nos níveis de beta amiloide plasmático
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 na escala de avaliação da doença de Alzheimer - escala de 11 itens e 12 itens da subpontuação cognitiva (ADAS-Cog11 e ADAS-Cog12)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80
Mudança da linha de base para a semana 80 no Estudo Cooperativo da Doença de Alzheimer - Pontuação do Inventário de Atividades da Vida Diária (ADCS-ADL)
Prazo: Linha de base, Semana 80
Linha de base, Semana 80

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eli Lilly and Company

Investigadores

  • Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 maio de 2009

Conclusão Primária (Real)

1 de junho de 2012

Conclusão do estudo (Real)

1 de junho de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2009

Primeira postagem (Estimativa)

20 de maio de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

13 de dezembro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de dezembro de 2012

Última verificação

1 de dezembro de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 11934
  • H8A-MC-LZAN (Outro identificador: Eli Lilly and Company)

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 .

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