- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01465360
Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup-A Pilot Descriptive Study
Descripción general del estudio
Estado
Descripción detallada
The objective of this study is to apply AclarusDx™ signature in a reference US Center in 160 patients newly referred to one of the three study centers within the Cleveland Clinic, Center for Brain Health network, for diagnostic workup. Only AclarusDx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of AclarusDx™ to provide Primary Care Physicians (PCPs) with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).
The primary objectives are :
- To obtain an estimate of the capability of AclarusDx™ to identify AD patients among a US-based population of newly referred patients suffering from objective memory impairment which maybe potentially related to multiple and different etiologies.
- To compare the performance of AclarusDx™ in a US-based population of newly referred patients with memory impairment with the performance of AclarusDx™ observed in one comparable European population.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Cleveland Clinic Lou Ruvo Center for Brain Health
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Center for Brain Health - Mellen Center
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Lakewood, Ohio, Estados Unidos, 44107
- Cleveland Clinic Senior Care Assessment - Lakewood Hospital
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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:
- Male or female patient referred to the center for memory impairment.
- The memory impairment has previously been observed by a caregiver or documented by a physician.
- The memory impairment is confirmed by the memory center.
- Caucasian ethnicity.
- A written informed consent approved by an ethical review board or similar body must be obtained from the patient prior to any study-related procedures.
- If applicable, standard treatment with cholinesterase inhibitor and/or memantine is acceptable.
- Patient estimated to be compliant with study procedures.
- Patient has a level of understanding sufficient to agree to all procedures required by the protocol and must be able to cooperate. Under no circumstances will a subject who does not understand the procedure, be allowed to consent to the procedure.
Exclusion Criteria:
- Recent acute pathology or medical condition or surgery which may alter the inflammatory homeostasis, according to the opinion of the investigator.
- Non-Caucasian ethnicity.
- Patient with severe uncontrolled or unstable medical condition.
- Need for a legal representative for the medical condition of the patient.
- Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
- Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions that are considered stable are accepted, provided that they are compatible with other study selection criteria.
- Current or recent history of drug or alcohol abuse or dependence.
- Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition text revised (DSM-IV TR), or significant symptoms (eg, hallucinations).
- Woman of childbearing potential is not allowed to participate in the study. (A woman of childbearing potential is a woman who is biologically capable of becoming pregnant).
- Current participation in another study using an investigational non-marketed product.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Study patients
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sensitivity of AclarusDx™ in AD patients
Periodo de tiempo: Outcome measured during one single study visit
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The determination of the sensitivity of the test, being the percentage of positive AclarusDx™ calls among referred patients being confirmed clinically as having AD at the Memory Center will be calculated.
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Outcome measured during one single study visit
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles B. Bernick, MD, Cleveland Clinic Lou Ruvo Center for Brain Health
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades metabólicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Manifestaciones neurológicas
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Proteinopatías TDP-43
- Deficiencias de proteostasis
- Tauopatías
- Trastornos cognitivos
- Trastornos del lenguaje
- Desordenes comunicacionales
- Enfermedades Arteriales Intracraneales
- Trastornos del habla
- Degeneración del lóbulo frontotemporal
- Arteriosclerosis intracraneal
- Leucoencefalopatías
- Enfermedad de Parkinson
- Demencia
- Enfermedad de Alzheimer
- Disfunción congnitiva
- Afasia
- Demencia frontotemporal
- Afasia Primaria Progresiva
- Elija la enfermedad del cerebro
- Demencia Vascular
Otros números de identificación del estudio
- EHTAD/003
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