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Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)

18 de setembro de 2012 atualizado por: Eli Lilly and Company

Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo

Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

1000

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

  • Argentina
      • Buenos Aires, Argentina, CBA 1419
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      • Cordoba, Argentina, X5004AOA
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      • Mendoza, Argentina, 5500
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      • Pueyrredon Cordoba, Argentina, X5005ALB
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      • Rosario, Argentina, S2000BZL
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      • Santa Fe, Argentina, S3000FWO
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  • Brasil
      • Curitiba, Brasil, 81210-310
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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, 20941-150
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      • São Paulo, Brasil, 04024-002
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  • Canadá
    • Alberta
      • Medicine Hat, Alberta, Canadá, T1B4E7
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    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y3G8
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      • Penticton, British Columbia, Canadá, V2A5C8
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    • Ontario
      • Ottawa, Ontario, Canadá, K1N 5C8
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      • Toronto, Ontario, Canadá, M6M 3Z5
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    • Quebec
      • Greenfield Park, Quebec, Canadá, J4V 2J2
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      • Sherbrooke, Quebec, Canadá, J1H1Z1
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  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85006
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      • Sun City, Arizona, Estados Unidos, 85351
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      • Tuscon, Arizona, Estados Unidos, 85718
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    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
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    • California
      • Carson, California, Estados Unidos, 90746
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      • Irvine, California, Estados Unidos, 92697
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      • Laguna Hills, California, Estados Unidos, 92653
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      • Lomita, California, Estados Unidos, 90717
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      • Orange, California, Estados Unidos, 92868
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      • Oxnard, California, Estados Unidos, 93030
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      • Santa Ana, California, Estados Unidos, 92705
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    • Colorado
      • Denver, Colorado, Estados Unidos, 80239
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    • Connecticut
      • Fairfield, Connecticut, Estados Unidos, 06824
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      • Hamden, Connecticut, Estados Unidos, 06518
        • 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 Haven, Connecticut, Estados Unidos, 06510
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      • Norwalk, Connecticut, Estados Unidos, 06851
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    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • 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.
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20007
        • 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
      • Boca Raton, Florida, Estados Unidos, 33431
        • 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.
      • Fort Myers, Florida, Estados Unidos, 33912
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      • Hollywood, Florida, Estados Unidos, 33021
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      • Miami Springs, Florida, Estados Unidos, 33166
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      • North Miami, Florida, Estados Unidos, 33161
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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
      • 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
      • Indianapolis, Indiana, Estados Unidos, 46202
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    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40503
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    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21285
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      • Rockville, Maryland, Estados Unidos, 20852
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    • Massachusetts
      • Belmont, Massachusetts, Estados Unidos, 02478
        • 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.
    • Michigan
      • Grand Rapids, Michigan, Estados Unidos, 49525
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      • Traverse City, Michigan, Estados Unidos, 49684
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    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
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    • New York
      • Albany, New York, Estados Unidos, 12205
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      • Bronx, New York, Estados Unidos, 10454
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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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      • Orangeburg, New York, Estados Unidos, 10962
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    • North Carolina
      • Raleigh, North Carolina, Estados Unidos, 27607
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      • Winston-Salem, North Carolina, Estados Unidos, 27103
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    • Ohio
      • Beachwood, Ohio, Estados Unidos, 44122
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      • Toledo, Ohio, Estados Unidos, 43623
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    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
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    • Oregon
      • Eugene, Oregon, Estados Unidos, 97401
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    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
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    • Rhode Island
      • East Providence, Rhode Island, Estados Unidos, 02914
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    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
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      • Greer, South Carolina, Estados Unidos, 29651
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    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57105
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    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84108
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    • Vermont
      • Bennington, Vermont, Estados Unidos, 05201
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      • Burlington, Vermont, Estados Unidos, 05401
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    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23502
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      • Roanoke, Virginia, Estados Unidos, 24018
        • 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.
  • Japão
      • Aichi, Japão, 474-8511
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      • Fukuoka, Japão, 812-0033
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      • Hiroshima, Japão, 720-0825
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      • Kanagawa, Japão, 243-8550
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      • Kyoto, Japão, 607-8062
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      • Osaka, Japão, 567
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      • Shizuoka, Japão, 420-8688
        • 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.
      • Tokyo, Japão, 187-8551
        • 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

Inclusion Criteria:

  • Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
  • Modified Hachinski Ischemia Scale score of less than or equal to 4
  • Geriatric Depression Scale score of less than or equal to 6
  • A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
  • If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization

Exclusion Criteria:

  • Has serious or unstable illness(es)
  • Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
  • Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
  • Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
  • Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
  • Has allergies to humanized monoclonal antibodies
  • Chronic alcohol and/or drug abuse within the past 5 years
  • Has any contraindications for MRI studies
  • Requires treatment with another monoclonal antibody

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
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks

Medidas de resultados secundários

Medida de resultado
Prazo
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels.
Prazo: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta
Prazo: Baseline, 80 weeks
Baseline, 80 weeks

Colaboradores e Investigadores

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

Patrocinador

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 abril de 2012

Conclusão do estudo (Real)

1 de abril 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)

25 de setembro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de setembro de 2012

Última verificação

1 de maio de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 6747
  • H8A-MC-LZAM (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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