- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00039702
Brain Imaging in Alzheimer's Disease
SPECT Imaging of Alpha4beta2 Nicotinic Acetylcholine Receptors Using [123I]5-I-A-85380 in Alzheimer's Disease
The purpose of this study is to use brain imaging technology to examine the role of certain brain chemicals in individuals with Alzheimer's disease (AD) and in healthy volunteers.
Cognitive dysfunction in people with AD is thought to arise from decreased chemical activity in specific parts of the brain. Decreases in alpha4beta2 nicotinic acetycholine receptors (nAChRs) have been found in the brains of people who died with AD; however, the status of this receptor system in living brains remains unclear. This study will use single photon emission computed tomography (SPECT) to study this receptor system in people with AD who have mild to moderate dementia and in healthy volunteers. In addition, this study will examine the relationship between cognitive dysfunction and nAChR deficits in the brains of individuals with AD.
Participants with AD will have four clinic visits; healthy volunteers will have three visits. At Visit 1, participants will undergo a medical history, physical examination, and laboratory tests. Healthy volunteers will have a Mini-Mental State Examination (MMSE) cognitive function test. Participants with AD will have a MMSE and measurement of the severity of their dementia.
During Visit 2, participants will undergo a magnetic resonance imaging (MRI) scan of the brain.
At Visit 3, participants will undergo SPECT imaging.
Only participants with AD will participate in Visit 4. During this visit, cognitive testing will be performed.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição
Contactos e Locais
Locais de estudo
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institute of Mental Health (NIMH)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
INCLUSION CRITERIA - ALZHEIMER'S DISEASE PATIENTS:
All AD patients will meet NINCDS-ADRDA criteria for probable AD with age of onset between 50 and 65 years of age.
The AD patients will be mild to moderately demented as assessed by the Mattis Dementia Rating Scale and Mini-Mental State Examination.
In particular, the AD patients will be nonsmokers because of known effects of smoking on nAChRs.
Patients will be characterized by their APOE genotype as nAChR changes might be different with differing doses of this allele.
We will not exclude AD patients from participating while they are on AChe inhibitors.
EXCLUSION CRITERIA - ALZHEIMER'S DISEASE PATIENTS:
We will exclude patients who are on galanthamine (Reminyl).
We will exclude patients on antidepressants and/or psychotropic drugs.
INCLUSION CRITERIA - CONTROLS:
Nonsmoking healthy individuals who satisfy the inclusion and exclusion criteria.
Plano de estudo
Como o estudo é projetado?
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.
- Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72. doi: 10.1212/wnl.43.8.1467.
- Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 020058
- 02-M-0058
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 .