Westlake Aging Cohort (WeAC) | NCT07373444

Studies
Westlake Aging Cohort (WeAC)

NCT07373444

Sponsor

Westlake University

Status

Not yet recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

2,800Estimated

Phase

Not provided

Conditions

Aging
Cognition Improvement
Cognition Disorders
Cognition

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Dec 24, 2025

First Submission Date that Met QC Criteria

Jan 19, 2026

First Posted Date

Jan 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2026

Last Update Posted Date

Jan 28, 2026Actual

Name	Class
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University	UNKNOWN
The Third People's Hospital of Hangzhou	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

All participants must be Chinese residents, regardless of their ethnicity.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ju-Sheng Zheng, PhD	Contact	86-0571-86915303		zhengjusheng@westlake.edu.cn

Name	Affiliation	Role
Ju-Sheng Zheng, PhD	Westlake University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hangzhou First People's Hospital		Hangzhou	Zhejiang	310058	China
Hangzhou Third People's Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019965	Neurocognitive Disorders
D001523	Mental Disorders