- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03846245
Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals (AlfaAge)
AlfaAge: Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals
Ageing is clearly the most important risk factor for AD and other dementias but, despite the amount of evidence supporting this fact, the exact mechanism that link ageing and AD is still unknown and, up to now, potential therapies for AD by targeting ageing have been poorly explored. This study aims to provide a better understanding of the link between ageing and AD by means of measuring in human blood those factors that have been found to be 'pro-youthful' (GDF-11, CSF2, TIMP-2, oxytocin) or 'pro-aging' (CCL2, CCL11, CCL19, Haptoglobine, B2-microglobuline) in experimental animal models, but have not been comprehensively studied in humans.
In this proof-of-concept study these blood factors in extreme groups of age, namely young adults (18-25 yo) and old adults (≥70 yo) will be measured and the hypothesis of whether the 'pro-youthful' and 'pro-ageing' blood factors change throughout age tested. In order to include a wider range of age, human umbilical cord blood and plasma from teenagers (which is already available from a previous study) will also be included.
The ultimate goal of this study is to select the more promising blood factors and obtain data on the effect size of the differences that may allow us in the future to design a larger study.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Barcelona, Espagne, 08005
- BarcelonaBeta Brain Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Men and women between 18 and 25 years (young adults group) or older than 70 for persons at the time of inclusion (old adults group).
- Subjects with no subjective cognitive complaints.
- Individuals interested in participating in the study who fully understand all the procedures that will be performed.
Explicit participant agreement to undergo all the study procedures, which encompass:
- Collection of basic demographic data.
- Collection of a blood sample.
- Give informed consent and agree that no data resulting from the study (which is no clinically relevant) will be given to the participant
Exclusion Criteria:
- No signs of subjective cognitive impairment.
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol. Including: auditive and visual impairment, renal insufficiency under hemodialysis treatment, hepatic cirrhosis, chronic pneumopathy under oxygen therapy, solid organ transplantation, fibromyalgia, active oncologic disease under treatment (excluding localized tumours).
- Any significant major psychiatric illness (following DSM-IV diagnosis manual) o diseases that interfere with cognitive function (including major depression disorder, bipolar disorder, schizophrenia).
- Acquired brain injury: brain traumatic injury with parenchymal or extra-axial macroscopic injury, large vessel ischemic stroke or hemorrhagic stroke, brain tumors or other conditions that may cause acquired brain injury (brain radio- or chemotherapy).
- Parkinson's disease, epilepsy under treatment and with frequent seizures (>1 /month) in the last year, multiple sclerosis or any other neurodegenerative disease.
- Researcher criteria: individuals that have any condition which, under researcher's view, could lead to difficulty complying with the protocol.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Young adults group
Cognitively unimpaired 18-25 years old
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Aucune intervention
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Old adults group
Cognitively unimpaired >= 70 years old
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Aucune intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Concentration of CCL2
Délai: at inclusion
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Differences in the concentration of CCL2 between age groups
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at inclusion
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Concentration of CCL11
Délai: at inclusion
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Differences in the concentration of CCL11 between age groups
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at inclusion
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Concentration of CCL19
Délai: at inclusion
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Differences in the concentration of CCL19 between age groups
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at inclusion
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Concentration of Haptoglobin
Délai: at inclusion
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Differences in the concentration of Haptoglobin between age groups
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at inclusion
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Concentration of B2-microglobulin
Délai: at inclusion
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Differences in the concentration of B2-microglobulin between age groups
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at inclusion
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Concentration of TIMP2
Délai: at inclusion
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Differences in the concentration of TIMP2 between age groups
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at inclusion
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Concentration of CSF2
Délai: at inclusion
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Differences in the concentration of CSF22 between age groups
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at inclusion
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Concentration of GDF11
Délai: at inclusion
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Differences in the concentration of GDF11 between age groups
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at inclusion
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Concentration of oxytoxin
Délai: at inclusion
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Differences in the concentration of oxytoxin between age groups
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at inclusion
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Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- AlfaAge/BBRC2018
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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