TRACK-ADTRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveSynucléinopathies+22
+ Maladie d'Alzheimer
+ Artériosclérose
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 janvier 2022
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.350 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 30 à 110 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Danish Dementia Research Centre
Copenhagen, DenmarkOuvrir Danish Dementia Research Centre dans Google Maps