TRACK-ADTRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades Oclusivas Arteriales+14
+ Trastornos Cerebrovasculares
+ Sinucleinopatías
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de enero de 2022
Fecha en la que se inscribió al primer participante.This study consist of three sub-studies. In study 1, participants diagnosed with mild cognitive impairment due to AD or mild to moderate AD will be followed for up to 24 months with repeated blood samples, pupillometry, actigraphy, cognitive tests and a control brain scan. In study 2, patients under investigation of a neurodegenerative disease who have a planned lumbar puncture in the Memory clinic will be invited to this study. Participants will undergo pupillometry and blood samples two times approximately one and four weeks after the lumbar puncture. In study 3, participants with a dementia diagnosis will undergo pupillometry and actigraphy at a single visit.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 350 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 110 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
Criterios
1. Longitudinal study: Inclusion criteria: * MCI due to AD, or mild or moderate AD dementia according to the National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria * Caregiver willing to participate as an informant * MMSE \>19 at inclusion * Brain FDG-PET/MRI or FDG/PET-CT * Able to cooperate to the investigations and give informed consent Exclusion criteria: * Other neurological or psychiatric illness that may affect neurofilament light (NfL) levels (severe neuropathy, multiple sclerosis (MS), stroke within the last 3 months, Wernicke encephalopathy) * Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years * Excessive alcohol intake or substance abuse within the last 2 years * Ophthalmological disorders that may affect pupillometry * Participating in drug trials or other intervention trials 2. Short-term study: Inclusion criteria: * Patients under investigation of a neurodegenerative disease * MMSE \>19 * Scheduled lumbar puncture/lumbar puncture performed within the last week prior to inclusion * Written consent form to the Danish Dementia Biobank * Able to cooperate to the investigations Exclusion criteria: * Other neurological or psychiatric illness that may affect NfL levels (severe neuropathy, MS, stroke within the last 3 months, Wernicke encephalopathy) * Excessive alcohol intake or substance abuse within the last 2 years * Ophthalmological disorders that may affect pupillometry * Participating in drug trials or other intervention trials 3. Cross-sectional study: Inclusion criteria - Patients: * A diagnosis of a dementia disorder * Caregiver willing to participate as an informant * MMSE \>15 at inclusion * Able to cooperate to the investigations * Able to give informed consent Exclusion criteria - Patients: * Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years * Excessive alcohol intake or substance abuse within the last 2 years * Other known brain disorder * Ophthalmological disorders that may affect pupillometry * Participating in drug trials or other intervention trials Inclusion criteria - Healthy Controls: * Able to cooperate to the investigations * Normal cognition * Age 50-90 year Exclusion criteria - Healthy Controls: * Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years * Excessive alcohol intake or substance abuse within the last 2 years * Other known brain disorder * Ophthalmological disorders that may affect pupillometry
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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
Danish Dementia Research Centre
Copenhagen, DenmarkAbrir Danish Dementia Research Centre en Google Maps