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The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography With Vesicular Monoamine Transporter Ligand (18F-DTBZ)

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

18F-FDG

Medicamento
Quiénes están siendo reclutados

Sinucleinopatías+4

+ Enfermedades de los Ganglios Basales

+ Enfermedades del Cerebro

De 20 a 80 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio Diagnóstico

Fase 2
Intervencional
Inicio del estudio: agosto de 2010
Ver detalles del protocolo

Resumen

Patrocinador PrincipalChang Gung Memorial Hospital
Última actualización: 13 de noviembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2010

Fecha en la que se inscribió al primer participante.

40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, will be enrolled. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit. Safety measurement will be evaluated by medical history, vital signs, physical examinations,

Patrocinador PrincipalChang Gung Memorial Hospital
Última actualización: 13 de noviembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 120 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio Diagnóstico

Los estudios diagnósticos se centran en mejorar como se detecta o confirma una enfermedad. Prueban nuevas herramientas o técnicas que podrían ofrecer diagnósticos más rápidos o precisos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 20 a 80 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

SinucleinopatíasEnfermedades de los Ganglios BasalesEnfermedades del CerebroEnfermedades del Sistema Nervioso CentralTrastornos del MovimientoEnfermedades del sistema nerviosoEnfermedad de Parkinson

Criterios

Inclusion Criteria: Forty subjects with a diagnosis of PD whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Forty subjects with a diagnosis of MSA whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II). iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Twenty subjects with a diagnosis of PSP whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP of "possible" or "probable" PSP35 (Appendix III). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Twenty subjects with a diagnosis of CBD whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Exclusion Criteria: Pregnant or becoming pregnant during the study or current breast feeding. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness. i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances. ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. History or presence of QTc prolongation. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed. Patients who have the evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded. General PET exclusion criteria.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
This study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Chang Gung Memory Hpspital

Taoyuan, TaiwanAbrir Chang Gung Memory Hpspital en Google Maps
Completado1 Centros de Estudio