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NCT Number: NCT07373444

Westlake Aging Cohort (WeAC)

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.

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Key information

Conditions

Aging Cognition Cognition Disorders Cognition Improvement Mental Disorders Neurocognitive Disorders

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou First People's Hospital, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Brain magnetic resonance imaging

    Time frame: 48 months

    Use brain magnetic resonance imaging (MRI) to measure the brain structure and function of participants.

  2. Positron emission tomography

    Time frame: 48 months

    Assess the brain function and neurological disorders by positron emission tomography (PET).

  3. Brain images relevant inspections

    Time frame: 48 months

    Other brain image relevant inspections required for study to measure brain structure and function of participants.

  4. 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.

  5. Blood biochemical parameters

    Time frame: 48 months

    Blood biochemical parameters, including glucose and lipids, will be analyzed using an automated biochemical analyzer.

  6. 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.

  7. Health and behavior monitoring

    Time frame: 48 months

    Use fitness trackers to record the physiological and behavioral data of participants.

  8. Sleep data measurement

    Time frame: 48 months

    Use the polysomnography (PSG) to record the sleep data of participants to evaluate the sleep quality.

  9. 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.

  10. Environmental measurement

    Time frame: 48 months

    Use the environmental monitoring device to measure various exposure factors in the participants' living environment.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ju-Sheng Zheng, PhD

CONTACT

[email protected]

86-0571-86915303

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
  • The Third People's Hospital of Hangzhou

Registry information

Official study title

Westlake Aging Cohort

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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