- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373444
Westlake Aging Cohort (WeAC)
January 19, 2026 updated by: Westlake University
Westlake Aging Cohort
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 investigators will collect their sociodemographic, dietary, lifestyle, clinical, and neuroimaging data, as well as biological samples.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
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 multi-omics data.
This database will be used to characterize the molecular signatures of neurodegenerative disorders.
In addition, the investigators will identify biomarkers associated with neurodegenerative diseases.
Furthermore, the investigators aim to uncover the mechanisms underlying the progression of mild cognitive impairment (MCI) and other neurodegenerative disorders.
Study Type
Observational
Enrollment (Estimated)
2800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ju-Sheng Zheng, PhD
- Phone Number: 86-0571-86915303
- Email: zhengjusheng@westlake.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310058
- Hangzhou First People's Hospital
-
Hangzhou, Zhejiang, China, 310058
- Hangzhou Third people's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
All participants must be Chinese residents, regardless of their ethnicity.
Description
Inclusion Criteria:
- 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.
Exclusion 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: 48 months
|
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
Time Frame: 48 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain magnetic resonance imaging
Time Frame: 48 months
|
Use brain magnetic resonance imaging (MRI) to measure the brain structure and function of participants.
|
48 months
|
|
Positron emission tomography
Time Frame: 48 months
|
Assess the brain function and neurological disorders by positron emission tomography (PET).
|
48 months
|
|
Brain images relevant inspections
Time Frame: 48 months
|
Other brain image relevant inspections required for study to measure brain structure and function of participants.
|
48 months
|
|
Electroencephalogram
Time Frame: 48 months
|
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
Time Frame: 48 months
|
Blood biochemical parameters, including glucose and lipids, will be analyzed using an automated biochemical analyzer.
|
48 months
|
|
Serum inflammatory factors
Time Frame: 48 months
|
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
Time Frame: 48 months
|
Use fitness trackers to record the physiological and behavioral data of participants.
|
48 months
|
|
Sleep data measurement
Time Frame: 48 months
|
Use the polysomnography (PSG) to record the sleep data of participants to evaluate the sleep quality.
|
48 months
|
|
Continuous glucose monitoring
Time Frame: 48 months
|
Use the continuous glucose monitoring (CGM) for dynamic blood glucose recording to determine the glycemic control of participants.
|
48 months
|
|
Environmental measurement
Time Frame: 48 months
|
Use the environmental monitoring device to measure various exposure factors in the participants' living environment.
|
48 months
|
|
Multi-omics data
Time Frame: 48 months
|
Multi omics results of detecting biological samples such as plasma, peripheral blood mononuclear cells (PBMCs), urine, feces, saliva, etc.
|
48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2031
Study Registration Dates
First Submitted
December 24, 2025
First Submitted That Met QC Criteria
January 19, 2026
First Posted (Actual)
January 28, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20251023ZJS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognition Disorders
-
ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRLNot yet recruiting
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
Wageningen UniversityWithdrawnAging | Cognitive Decline | Cognition Disorders in Old Age
-
Eye & ENT Hospital of Fudan UniversityUnknownCognition Disorders in Old AgeChina
-
University of California, Los AngelesCompleted
-
Institut GuttmannUniversidad Politecnica de MadridEnrolling by invitationCognitive Decline | Cognition | Prevention | Brain Health ActivitiesSpain
-
Amsterdam UMC, location VUmcCompletedDepression | Impaired Cognition | Alteration in Cognition | Late Life Mood Disorder | Alteration in MoodNetherlands
-
German University in CairoRecruitingCognition Disorders in Old Age | Cognitive and Behavioral ImpairmentEgypt
-
George Mason UniversityCompletedImpaired Cognition | EmotionUnited States
-
Distribuidora Biolife SA de CVRecruiting