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RecruitingNCT07912710Updated Nov 3, 2026

China HEalthy Aging and Dementia Study (HEAD)

An observational study in Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Dementia, sponsored by Fudan University. Recruiting at 30 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 3 months later.
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years and older
Sex
All
01

Study summary

The China HEalthy Aging and Dementia (HEAD) study is a large-scale, community-based, multi-center prospective cohort study covering eastern, northern, southern, and central-western regions of China. By integrating comprehensive clinical, neuroimaging, biospecimen, and multi-omics data, the study aims to advance the early prediction and diagnosis of Alzheimer's disease and related dementias (ADRD) and provide a foundation for future intervention studies in the Chinese population.

The primary aims of the China HEAD study are as follows:

  1. To establish a community-based prospective cohort by recruiting over 20,000 participants from eastern, northern, southern, western, and middle regions of China.
  2. To build a comprehensive biobank by collecting demographic information, disease history, cognitive function, physical measures, electrophysiologic data, multimodal imaging data, as well as biospecimens and derived multi-omics data.
  3. To conduct early prediction and diagnosis studies for ADRD and support future intervention studies based on the above-mentioned cohort and biobank.
Read the detailed description

The China HEalthy Aging and Dementia (HEAD) study is a large prospective community study aiming to recruit 20,000 participants. The participants are recruited from 14 provinces distributed in eastern, northern, southern, western, and middle regions of China by investigators from 33 centers. The study was approved by the Ethics Committee of Huashan Hospital of Fudan University with approval number KY2022-879. Written informed consent is obtained from each participant at recruitment.

At baseline, all participants undergo questionnaires, neuropsychological assessment, physical measures, and biospecimen collection. Part of the participants further receive electrophysiologic and imaging examinations. Long-term follow-up is planned for up to 50 years, with assessments conducted approximately annually, subject to participant availability and continued participation. Biospecimen collection and imaging examinations are performed as feasible and are not necessarily repeated at every follow-up visit.

The main research contents are as follows:

  1. Cohort establishment and cognitive aging research. The HEAD study aims to establish a nationwide community-based prospective cohort and investigate the natural progression of cognitive aging, cognitive impairment, and Alzheimer's disease and related dementias (ADRD) in the Chinese population. The study will investigate cognitive changes and the progression from normal cognition to mild cognitive impairment (MCI) and dementia through longitudinal follow-up.
  2. Questionnaires and neuropsychological assessment. A standardized questionnaire administered by trained interviewers is used to collect demographic information, lifestyle and environmental factors, family history, disease history, medication intake, and the status of specific peripheral organs. The HEAD cohort evaluates cognition, emotion, living ability, and sleep quality with a battery of neuropsychological tests. Global cognitive function is assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). Cognitive subdomains including memory, working memory, attention, executive function, visuospatial function, and language are assessed using standardized neuropsychological tests. Emotional status, activity of daily living, and sleep quality are also evaluated.
  3. Physical measures and biospecimen collection. Anthropometric and hemodynamic parameters, including height, weight, neck circumference, waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure, and pulse rate, are measured according to standardized protocols. All enrolled participants are consented to the collection of blood, urine, and stool. Some participants also provide mucosal secretions, including nasopharyngeal swabs, tears, and saliva, while a subset undergoes lumbar puncture for cerebrospinal fluid (CSF) collection. All biospecimens are collected, processed, transported, and stored according to standardized protocols.
  4. Electrophysiologic and imaging examinations. Some participants undergo electrophysiologic examinations, including electrocardiography (ECG) and electroencephalography (EEG). Participants without contraindications to magnetic resonance imaging (MRI) are offered multimodal brain MRI scans, including structural MRI, diffusion tensor imaging (DTI), resting-state functional MRI (fMRI), arterial spin labeling (ASL), and quantitative susceptibility mapping (QSM). Positron emission tomography (PET) scans are also provided to detect cerebral amyloid-β (Aβ) and tau deposition and glucose metabolism. Additional examinations include carotid artery ultrasound, echocardiography, abdominal ultrasound, lower extremity vascular ultrasound, and dual-energy X-ray absorptiometry (DXA) assessment.
  5. Biospecimen assays and multi-omics studies. The collected biospecimens are used for routine laboratory examinations, AD biomarker measurements, and multi-omics investigations. The detection of core AD biomarkers in plasma and CSF is performed using standardized protocols, mainly based on single molecule array (SIMOA) technology and enzyme-linked immunosorbent assay (ELISA). The biomarkers include Aβ1-42, Aβ1-40, phosphorylated tau (p-tau) 181, p-tau 217, total tau (t-tau), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP). Whole-genome sequencing (WGS), transcriptomics, proteomics, metabolomics, metagenomics, and epigenomics are also performed to investigate the molecular characteristics of ADRD.
  6. Risk factors and prediction study. The risk factors for ADRD incidence and progression will be investigated, incorporating both cross-sectional data across different stages of ADRD and longitudinal data. Genetic factors detected in genome sequencing and modifiable factors, mainly extracted from questionnaires and physical measures, are considered. Based on identified factors, the study aims to establish a generalizable risk prediction model for ADRD.
  7. Biomarkers and diagnosis study. Fluid and imaging biomarkers will be screened and validated for early and precise diagnosis of ADRD. Based on identified biomarkers, diagnostic criteria will be developed and compared with the well-accepted amyloid-β, tau, and neurodegeneration (ATN) framework.
02

Conditions studied

  • Alzheimer Disease (AD)
  • Mild Cognitive Impairment (MCI)
  • Dementia
  • Vascular Dementia (VaD)
  • Cognitive Decline
  • Familial Alzheimer Disease (FAD)
  • Non-Alzheimer Degenerative Dementia

Keywords

  • China HEalthy Aging and Dementia Study
  • Cognitive aging
  • Alzheimer's disease and related dementias
  • Early prediction
  • Early diagnosis
  • Risk factors
  • Neuropsychological assessment
  • Biomarkers
  • Multimodal neuroimaging
  • Multi-omics
  • Longitudinal study
  • Community-based cohort
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The China HEalthy Aging and Dementia (HEAD) study is a nationwide, multicenter, community-based prospective cohort study aiming to recruit at least 20,000 participants from eastern, northern, southern, western, and central regions of China. The study comprises four regional community cohorts of individuals aged 50-79 years and a familial HEAD sub-cohort of individuals aged 18 years or older with a family history of Alzheimer's disease. Participants are recruited using standardized protocols to ensure harmonized data collection and quality control across participating centers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

China HEAD Community Cohort:

  1. Resident in a Chinese community.
  2. Aged 50-79 years.
  3. Have adequate vision and hearing (with glasses or hearing aids if necessary), and be able to walk, communicate, and complete study-related assessments (including questionnaires, physical examinations, neuropsychological assessments, and biospecimen collection) independently or with assistance.
  4. Willing to provide written for baseline assessments, follow-up, biospecimen donation, and data collection.

China HEAD Familial Sub-cohort:

  1. Resident in a Chinese community.
  2. Aged 18 years or older.
  3. Have a family history of Alzheimer's disease (AD) involving at least two first-degree relatives across at least two consecutive generations, with AD diagnoses previously established at tertiary hospitals and verified through medical history.
  4. Meet the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for AD.
  5. Have adequate vision and hearing (with glasses or hearing aids if necessary), and be able to walk, communicate, and complete study-related assessments (including questionnaires, physical examinations, neuropsychological assessments, and biospecimen collection) independently or with assistance.
  6. Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.

Exclusion criteria

Exclusion Criteria:

The following exclusion criteria apply to participants in the HEAD study:

  1. Refusal to provide written .
  2. Refusal to participate in questionnaires or other data collection procedures.
  3. Refusal to provide blood or other biological samples.
  4. Self-reported stroke events (e.g., cerebral hemorrhage or cerebral infarction) within the past six months.
  5. Self-reported diseases potentially impairing cognition, including congenital intellectual disability, intracranial tumors, epilepsy, Parkinson's disease, or severe psychiatric disorders such as schizophrenia requiring medication.
  6. Self-reported major organ failure (e.g., liver or kidney failure), , or other conditions associated with a shortened that prevent completion of follow-up assessments.

Additional exclusion criteria for participants undergoing magnetic resonance imaging (MRI):

1. Inability to tolerate MRI examinations or to MRI, including claustrophobia; MRI-incompatible implanted pacemakers, aneurysm clips, artificial heart valves, cochlear implants, or other metallic implants; or other clinical conditions or examination findings that investigators consider potentially harmful during MRI.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Target follow-up
50 Years
Patient registry
Yes

Groups and cohorts

  • China HEAD Community Cohort

    A nationwide, multicenter, community-based prospective cohort of individuals aged 50-79 years from eastern, northern, southern, western, and central regions of China, established using standardized protocols to ensure harmonized data collection and quality control across participating centers.

  • China HEAD Familial Sub-cohort

    A nationwide, multicenter prospective sub-cohort of individuals aged 18 years or older with a family history of Alzheimer's disease, established using standardized protocols to ensure harmonized data collection and quality control across participating centers.

06

What researchers measure

Primary outcomes

  1. Mild cognitive impairment (MCI)

    MCI is diagnosed according to the 2004 International Working Group (IWG) broad clinical criteria. Diagnostic status is assessed at baseline and during follow-up.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  2. Dementia

    Dementia is diagnosed according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for all-cause dementia. Diagnostic status is assessed at baseline and during follow-up.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  3. Mild cognitive impairment due to Alzheimer's disease (MCI due to AD)

    MCI due to AD is diagnosed according to the 2011 NIA-AA clinical criteria, based on the presence of MCI and clinical evidence consistent with AD etiology. Diagnostic status is assessed at baseline and during follow-up.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  4. Dementia due to Alzheimer's disease (AD dementia)

    AD dementia is diagnosed according to the 2011 NIA-AA clinical criteria for probable or possible Alzheimer's disease dementia among participants meeting the criteria for all-cause dementia. Diagnostic status is assessed at baseline and during follow-up.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  5. Mini-Mental State Examination (MMSE) total score

    Global cognitive function is assessed using the MMSE (range: 0-30; higher scores indicate better cognition). Longitudinal changes are used to evaluate the rate of cognitive decline.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  6. Montreal Cognitive Assessment (MoCA) total score

    Global cognitive function is assessed using the MoCA (range: 0-30; higher scores indicate better cognition). Longitudinal changes are used to evaluate the rate of cognitive decline.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  7. Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score

    Cognitive and functional impairment is assessed using CDR-SB (range: 0-18; higher scores indicate greater impairment). Longitudinal changes are used to evaluate the rate of decline.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

Secondary outcomes

  1. Auditory Verbal Learning Test (AVLT) learning score

    Verbal learning is assessed using the sum of correctly recalled words across AVLT learning trials N1-N3. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  2. Auditory Verbal Learning Test (AVLT) short-delay recall score

    Short-delay memory is assessed using the number of correctly recalled words in AVLT N4. Higher scores indicate better memory performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  3. Auditory Verbal Learning Test (AVLT) long-delay recall score

    Long-delay memory is assessed using the number of correctly recalled words in AVLT N5. Higher scores indicate better memory performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  4. Forward Digit Span Test score

    Attention and immediate memory are assessed using the maximum number of digits correctly recalled in forward order. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  5. Backward Digit Span Test score

    Working memory is assessed using the maximum number of digits correctly recalled in reverse order. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  6. Trail Making Test Part A (TMT-A) completion time

    Attention and processing speed are assessed using TMT-A completion time in seconds. Longer times indicate poorer performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  7. Trail Making Test Part B (TMT-B) completion time

    Executive function is assessed using TMT-B completion time in seconds. Longer times indicate poorer performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  8. Clock Drawing Test (CDT) total score

    Visuospatial function is assessed using the CDT (range: 0-30; higher scores indicate better performance). Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  9. Verbal Fluency Test (VFT) total score

    Verbal fluency is assessed using the total number of valid words generated across the administered categories. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments.

    Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)

  10. Plasma amyloid-β 1-42 (Aβ1-42) concentration

    Plasma Aβ1-42 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  11. Plasma amyloid-β 1-40 (Aβ1-40) concentration

    Plasma Aβ1-40 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  12. Plasma amyloid-β 1-42/1-40 ratio (Aβ1-42/Aβ1-40)

    The plasma Aβ1-42/Aβ1-40 ratio is calculated from measured plasma concentrations (unitless). Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  13. Plasma phosphorylated tau 181 (p-tau181) concentration

    Plasma p-tau181 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  14. Plasma phosphorylated tau 217 (p-tau217) concentration

    Plasma p-tau217 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  15. Plasma total tau (t-tau) concentration

    Plasma t-tau concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  16. Plasma neurofilament light chain (NfL) concentration

    Plasma NfL concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  17. Plasma glial fibrillary acidic protein (GFAP) concentration

    Plasma GFAP concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  18. Cerebrospinal fluid amyloid-β 1-42 (Aβ1-42) concentration

    CSF Aβ1-42 concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  19. Cerebrospinal fluid amyloid-β 1-40 (Aβ1-40) concentration

    CSF Aβ1-40 concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  20. Cerebrospinal fluid amyloid-β 1-42/1-40 ratio (Aβ1-42/Aβ1-40)

    The CSF Aβ1-42/Aβ1-40 ratio is calculated from measured CSF concentrations (unitless). Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  21. Cerebrospinal fluid phosphorylated tau 181 (p-tau181) concentration

    CSF p-tau181 concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  22. Cerebrospinal fluid phosphorylated tau 217 (p-tau217) concentration

    CSF p-tau217 concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  23. Cerebrospinal fluid total tau (t-tau) concentration

    CSF t-tau concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  24. Cerebrospinal fluid neurofilament light chain (NfL) concentration

    CSF NfL concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  25. Cerebrospinal fluid glial fibrillary acidic protein (GFAP) concentration

    CSF GFAP concentration is measured in participants with available CSF samples. Longitudinal changes are evaluated when repeated measurements are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  26. Regional brain atrophy assessed by structural MRI

    Regional brain atrophy is assessed using structural MRI in participants with available imaging data. Longitudinal changes are evaluated when repeated scans are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

  27. Cerebral amyloid-β burden assessed by PET

    Cerebral amyloid-β deposition is assessed using amyloid PET in participants with available imaging data. Longitudinal changes are evaluated when repeated scans are available.

    Time frame: Baseline and follow-up assessments (up to 50 years)

07

Study locations

30 of 30 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912710
Lead sponsor
Fudan University
Collaborators
Beijing Normal University, Fujian Medical University, Wuhan University of Science and Technology, Beijing University of Posts and Telecommunications, Qingdao University, BGI-research, Peking University, Sun Yat-sen University, Sichuan University, Jilin University, Tongji University, Southeast University, China, Peking Union Medical College Hospital, Chinese PLA General Hospital, Ruijin Hospital, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Tianjin Medical University, Shandong First Medical University, Shanghai University, Shenzhen University, Zhoukou Central Hospital, Fudan University Taizhou Institute of Health Sciences, Qinghai People's Hospital, Shenzhen Bay Laboratory, The First Affiliated Hospital of Xiamen University, Southern Medical University, China, United Imaging Healthcare North America, Inc., Army Medical University, China, The First Affiliated Hospital of University of Science and Technology of China, Shanghai University of Medicine and Health Sciences, Tianchangyuan Pharmaceutical (Jilin) Co., Ltd., Xuanwu Hospital, Beijing, Beijing Tiantan Hospital
Responsible party
Jintai Yu (Professor of Neurology, Fudan University) — Principal investigator
First posted
Nov 3, 2026
Start date
Aug 1, 2022
Primary completion
Aug 1, 2072 (estimated)
Completion
Aug 1, 2072 (estimated)
Last update
Nov 3, 2026

Study contacts

Jin-Tai Yu, MD, PhD
Contact
jintai_yu@fudan.edu.cn
+86 18678999982
Jin-Tai Yu, MD, PhD
study chair · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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