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- Ensaio Clínico NCT00287248
Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain
6 de março de 2014 atualizado por: Danna Jennings, MD, Institute for Neurodegenerative Disorders
Evaluation of [123I] IMPY and SPECT as a Marker of Beta-amyloid Protein Deposition in the Brain of Healthy Subjects and Patients With Alzheimer Disease
This research is designed to obtain efficacy and safety information for 123-I IMPY as an imaging biomarker for Alzheimer's disease (AD).
The distribution of this agent will be measured by obtaining single photon emission computed tomography (SPECT) images of the brain serially over time to determine the relative localization of the radiopharmaceutical in regions of the cortex relative to background regions and develop an optimal technique of radiotracer administration (bolus or bolus with constant infusion).
The researchers will then evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and subsequently serial evaluations of AD patients will be performed to determine if this technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in AD.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImanging (MNI) in New Haven, CT.
Approximately 25 patients with mild to moderate Alzheimer's disease (AD) and 20 healthy controls will be recruited to participate in this study.
AD patients will be eligible to participate if they have a diagnosis of AD of less than 3 years duration.
Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects will be asked to undergo either a bolus injection or bolus injection followed by continuous infusion of 123-I IMPY.
Following injection, subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I IMPY in plasma (both protein bound and free) over a 3.5 - 8 hour period.
The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I IMPY.
Tipo de estudo
Intervencional
Inscrição (Real)
38
Estágio
- Fase 1
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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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Institute for Neurodegenerative Disorders
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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
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRA) criteria.
- Mini-Mental Status Exam score > 16 and < 25.
- Patients have a diagnosis of probable AD for < 3 years prior to screening.
Exclusion Criteria:
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
- Subjects with an iodine allergy.
- The subject has a clinically significant clinical laboratory value and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder.
- The subject has received an investigational drug within 60 days before the screening visit.
- Pregnancy
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: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Assess [123I] IMPY & SPECT Imaging
To assess [123I] IMPY & SPECT Imaging
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Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with β-amyloid deposition in AD patients relative to controls
Prazo: 2 years
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2 years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition
Prazo: 2 years
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2 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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.
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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 fevereiro de 2006
Conclusão Primária (Real)
1 de fevereiro de 2008
Conclusão do estudo (Real)
1 de março de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
2 de fevereiro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de fevereiro de 2006
Primeira postagem (Estimativa)
6 de fevereiro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de março de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de março de 2014
Última verificação
1 de março de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AMYLOID001
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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