NCT07373444

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Dec 2031

First Submitted

Initial submission to the registry

December 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 24, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

agingcognitiongut microbiotamulti-omicsbrain

Outcome Measures

Primary Outcomes (2)

  • 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 (11)

  • Brain magnetic resonance imaging

    48 months

  • Positron emission tomography

    48 months

  • Brain images relevant inspections

    48 months

  • Electroencephalogram

    48 months

  • Blood biochemical parameters

    48 months

  • +6 more secondary outcomes

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310058, China

Location

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Study Officials

  • Ju-Sheng Zheng, PhD

    Westlake University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 28, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations