Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations

Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations

Patrocinadores

Patrocinador principal: Columbia University

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente Columbia University
Resumen breve

The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. Up to three 18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.

Descripción detallada

Approximately 40% of cases of Frontotemporal lobar Degeneration (FTLD) are also associated with abnormal deposition of tau protein. The purpose of this study is to image MAPT mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in Frontotemporal Lobar Degeneration with tau deposition (FTLD-tau).

Estado general Completed
Fecha de inicio April 2016
Fecha de Terminación November 25, 2018
Fecha de finalización primaria November 25, 2018
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
SUVR of 18F-AV-1451 Baseline, 12-month follow up
Inscripción 7
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: 18F-AV-1451

Descripción: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.

Etiqueta de grupo de brazo: 18F-AV-1451

Otro nombre: [18F]AV-1451

Elegibilidad

Criterios:

Inclusion Criteria:

- Members of families with established MAPT mutations, who either have the capacity to consent to participate in the protocol, or else have designated a surrogate/proxy to consent to participate in this study

Exclusion Criteria:

- Unwillingness to participate

- Usage of medication which significantly prolongs QT interval

- Pregnancy or plans for pregnancy within 90 days after participating in study

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Edward Huey, MD Principal Investigator Columbia University
Ubicación
Instalaciones: Morton A. Kreitchman PET Center
Ubicacion Paises

United States

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Columbia University

Nombre completo del investigador: Edward D Huey, MD

Título del investigador: Assistant Professor of Psychiatry and Neurology

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: 18F-AV-1451

Tipo: Experimental

Descripción: Subjects who are microtubule associated protein tau (MAPT) family carriers and non-carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.

Datos del paciente Yes
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Diagnostic

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov