- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02616679
Cognitive Detection of Preclinical AD: Validation Using Biomarkers
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Biomarkers, such as amyloid deposition, and Hipp volume loss, and low Aβ and high pTau in CSF, are useful for identifying cognitively normal (CN) elderly who are likely have early AD pathology ("preclinical AD"). However, they are invasive and/or expensive. The goal of the current study is to develop and validate cognitive proxies of AD biomarkers by using cognitive tasks that are dependent on brain regions impaired by very early AD pathology. If successful, these tasks will provide a non-invasive and cost-effective way to identify and track change in CN individuals at high risk for progressing to mild cognitive impairment (MCI) and dementia stages of AD and thus will facilitate future prevention trials in pAD.
Subjects will attend three study visits. During the first study visit, subjects will have eligibility criteria confirmed, have a blood sample drawn, and complete about half of the cognitive tasks. The second visit, which will occur within one week of visit one, will involve completion of the remaining cognitive tasks. Subjects will also be asked to have a PET-CT scan during visit three (to occur within 3 months of visits 1 and 2).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Prior enrollment as a participant in the NYU Alzheimer's Disease Center (ADC) and completion of the ADC Clinical Evaluation within the past year.
- Clinical diagnosis of "cognitively normal" or "amnestic mild cognitive impairment" based on recent (within 1 year) consensus meeting cross-referenced with standard neuropsychological scores.
- Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).
Exclusion Criteria:
- Significant history of mental illness, drug or alcohol abuse; severe trauma preventing normal use of dominant hand (needed to move the mouse cursor); clinical depression (unless medically controlled); other neurologic conditions (i.e. stroke), or learning disability; ophthalmologic/visual problems that prevent viewing a computer screen at a normal distance (such as legal blindness, detached retinas, occlusive cataracts).
- Lack of capacity to give informed consent and no legally authorized representative to provide consent.
- Having pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in body and therefore, unable to receive MRI.
- Pregnancy, breastfeeding or planning to have a baby.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
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Cognitively Normal
Participants will be deemed cognitively normal based on criteria set forth by the National Alzheimer's Disease Coordinating Center/Alzheimer's Disease Centers (ADCC/ADC).
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Amnestic Mild Cognitive Impairment (aMCI)
Participants will be deemed aMCI based on criteria set forth by the National Alzheimer's Disease Coordinating Center/Alzheimer's Disease Centers (ADCC/ADC).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Correlation of composite score on cognitive tests with biomarkers
Periodo de tiempo: 3 months
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The overall score on the cognitive tests will be correlated via a linear regression with biomarker data collected during the study.
Each biomarker will be regressed individually.
Biomarker data includes: MRI hippocampus (hipp) volume, entorhinal cortex (EC) volume, EC standard uptake value ratios (SUVRs), Hipp SUVR, precuneus (PCu) SUVR, PET-[18F] Flutemetamol SUVR, CSF Aβ and tau levels, levels of diffusion tensor imaging mean diffusivity, and levels of fractional anisotropy.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Presence of ApoE allele
Periodo de tiempo: 3 months
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3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Martin Sadowski, PhD, NYU Langone Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-00706
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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