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L'essai clinique NCT07373444 pour Vieillissement, Cognition Improvement, Troubles de la cognition, Cognition est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Westlake Aging Cohort (WeAC) 2 800 Mode de vie Diététique Suivi long terme
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L'essai clinique NCT07373444 est une étude observationnel pour Vieillissement, Cognition Improvement, Troubles de la cognition, Cognition. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 janvier 2026, avec un objectif de 2 800 participants. Dirigée par Westlake University, l'étude devrait être terminée d'ici le 31 décembre 2031. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 janvier 2026.
Résumé succinct
The Westlake Ageing Cohort (WeAC) is a longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The investigators aim to enroll 2,800 participants aged 55 years and older for long-term follow-up. The population will include individuals with neurodegenerative diseases or those at the prodromal stage of cognitive impairment, as well as healthy middle-aged and older adults serving as controls. The inve...Afficher plus
Description détaillée
The investigators will recruit middle-aged and aged participants, including healthy controls and individuals with neurodegenerative disorders such as mild cognitive impairment (MCI), Alzheimer's disease (AD), Parkinson's disease dementia (PDD), and dementia with Lewy bodies (DLB), etc. The aim of this study is to construct a longitudinal database that includes sociodemographic, lifestyle, clinical, neuroimaging, and ...Afficher plus
Titre officiel
Westlake Aging Cohort
Pathologies
VieillissementCognition ImprovementTroubles de la cognitionCognitionAutres identifiants de l'étude
- 20251023ZJS001
Numéro NCT
Date de début (réel)
2026-01-01
Dernière mise à jour publiée
2026-01-28
Date de fin (estimée)
2031-12-31
Inscription (estimée)
2 800
Type d'étude
Observationnel
Statut
Pas encore en recrutement
Mots clés
aging
cognition
gut microbiota
multi-omics
brain
cognition
gut microbiota
multi-omics
brain
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Cognitive function | Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE, score range: 0-30, with higher scores indicating better cognitive function) and clinical diagnosis provided by physicians. | 48 months |
Gut microbiome | The gut microbiome will be profiled by metagenomic sequencing or ITS rRNA sequencing. In addition, fecal microbiota will be cultured, isolated, and identified. | 48 months |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Brain magnetic resonance imaging | Use brain magnetic resonance imaging (MRI) to measure the brain structure and function of participants. | 48 months |
Positron emission tomography | Assess the brain function and neurological disorders by positron emission tomography (PET). | 48 months |
Brain images relevant inspections | Other brain image relevant inspections required for study to measure brain structure and function of participants. | 48 months |
Electroencephalogram | Electroencephalogram (EEG) monitors the electrical activity of the brain. And further measure based on coupled EEG/MEG and eye-tracking. | 48 months |
Blood biochemical parameters | Blood biochemical parameters, including glucose and lipids, will be analyzed using an automated biochemical analyzer. | 48 months |
Serum inflammatory factors | Detect and assess serum inflammatory factors such as IL-1β, IL-6, and IL-12, in serum from participants. | 48 months |
Health and behavior monitoring | Use fitness trackers to record the physiological and behavioral data of participants. | 48 months |
Sleep data measurement | Use the polysomnography (PSG) to record the sleep data of participants to evaluate the sleep quality. | 48 months |
Continuous glucose monitoring | Use the continuous glucose monitoring (CGM) for dynamic blood glucose recording to determine the glycemic control of participants. | 48 months |
Environmental measurement | Use the environmental monitoring device to measure various exposure factors in the participants' living environment. | 48 months |
Multi-omics data | Multi omics results of detecting biological samples such as plasma, peripheral blood mononuclear cells (PBMCs), urine, feces, saliva, etc. | 48 months |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
55 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Age between 55 and 90 years (inclusive) at baseline.
- Availability of a companion capable of providing independent functional assessments and fluent in Chinese.
- Willingness and ability to regularly complete required surveys and physical examinations as per study protocol.
- MMSE scores were required to be 24-30 (inclusive) for healthy controls and MCI; and 20-24 (inclusive) for AD and DLB/PDD patients.
- Healthy controls: CDR = 0, memory box = 0. MCI: CDR = 0.5, memory box ≥ 0.5. AD: CDR = 0.5 or 1. The DLB/PDD meets the core features of diagnosis.
- Healthy controls exhibit no significant cognitive or functional decline. Patients with MCI have objective cognitive impairment not sufficient for an AD diagnosis. AD patients fulfill the NINCDS-ADRDA criteria. DLB/PDD patients meet their respective international consensus diagnostic criteria. Other neurodegenerative diseases meet the diagnostic criteria.
- Participants with major medical or neuropsychiatric conditions unrelated to the study purposes were excluded. These included, but were not limited to, psychiatric disorders, cancer, infectious diseases, structural brain abnormalities, and epilepsy.
- Current use of psychoactive medications or any other drugs that may affect the study.
- Participants with cardiac pacemakers, artificial heart valves, or metallic implants in the eyes, skin, or any other part of the body.
- Participants with any other diseases that may affect the study.
Westlake University- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
- The Third People's Hospital of Hangzhou
Contact central de l'étude
Contact: Ju-Sheng Zheng, PhD, 86-0571-86915303, [email protected]
2 Centres de l'étude dans 1 pays
Zhejiang
Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310058, China
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310058, China