- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Barcelona, España, 08005
- BarcelonaBeta Brain Research Center
-
-
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:
- 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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Young adults group
Cognitively unimpaired 18-25 years old
|
Sin intervención
|
Old adults group
Cognitively unimpaired >= 70 years old
|
Sin intervención
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Concentration of CCL2
Periodo de tiempo: at inclusion
|
Differences in the concentration of CCL2 between age groups
|
at inclusion
|
Concentration of CCL11
Periodo de tiempo: at inclusion
|
Differences in the concentration of CCL11 between age groups
|
at inclusion
|
Concentration of CCL19
Periodo de tiempo: at inclusion
|
Differences in the concentration of CCL19 between age groups
|
at inclusion
|
Concentration of Haptoglobin
Periodo de tiempo: at inclusion
|
Differences in the concentration of Haptoglobin between age groups
|
at inclusion
|
Concentration of B2-microglobulin
Periodo de tiempo: at inclusion
|
Differences in the concentration of B2-microglobulin between age groups
|
at inclusion
|
Concentration of TIMP2
Periodo de tiempo: at inclusion
|
Differences in the concentration of TIMP2 between age groups
|
at inclusion
|
Concentration of CSF2
Periodo de tiempo: at inclusion
|
Differences in the concentration of CSF22 between age groups
|
at inclusion
|
Concentration of GDF11
Periodo de tiempo: at inclusion
|
Differences in the concentration of GDF11 between age groups
|
at inclusion
|
Concentration of oxytoxin
Periodo de tiempo: at inclusion
|
Differences in the concentration of oxytoxin between age groups
|
at inclusion
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AlfaAge/BBRC2018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Sin intervención
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia