Alzheimer Disease (AD)NCT07912710
China HEalthy Aging and Dementia Study (HEAD)
An observational study of Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by Fudan University at 30 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia
- How many people
- 20,000 participants
- Where
- 30 sitesChina
- Study dates
- 1 Aug 2022to 1 Aug 2072
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- China HEAD Community Cohort:
- Resident in a Chinese community.
- Aged 50-79 years.
- 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.
- Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.
- China HEAD Familial Sub-cohort:
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- Resident in a Chinese community.
- Aged 18 years or older.
- 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.
- Meet the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for AD.
- 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.
- Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.
Who cannot join
- The following exclusion criteria apply to participants in the HEAD study:
- Refusal to provide written informed consent.
- Refusal to participate in questionnaires or other data collection procedures.
- Refusal to provide blood or other biological samples.
- Self-reported stroke events (e.g., cerebral hemorrhage or cerebral infarction) within the past six months.
- 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.
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- Self-reported major organ failure (e.g., liver or kidney failure), malignancy, or other conditions associated with a shortened life expectancy that prevent completion of follow-up assessments.
- Additional exclusion criteria for participants undergoing magnetic resonance imaging (MRI):
- 1. Inability to tolerate MRI examinations or contraindications 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Beijing Normal University
Beijing
Zhan-Jun Zhang, +86 13601017639, zhang_rzs@bnu.edu.cn
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Lin Ai, +86 13601085250, ttnmal@126.com
- Recruiting
Beijing University of Posts and Telecommunications
Beijing
Yong Liu, +86 13693065534, yongliu@bupt.edu.cn
- Recruiting
Chinese PLA General Hospital
Beijing
Hong-Xiang Yao, +86 15901153301, yaohx301@163.com
- Recruiting
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing
Jun-Ying Zhang, +86 15110259921, zhangjuny1985@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing
Na Niu, +86 13146622493, niunayy@sina.com
- Recruiting
Peking University
Beijing
Jun-Liang Yuan, +86 13401139148, junliangyuan@bjmu.edu.cn
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Long-Fei Jia, +86 13699225589, longfei@mail.ccmu.edu.cn
- Recruiting
Jilin University
Changchun
Yu Yang, +86 15804301809, yang_yu@jlu.edu.cn
- Recruiting
Sichuan University
Chengdu
Xue-Ping Chen, +86 13540889996, chenxueping0606@sina.com
- Recruiting
Army Medical University, China
Chongqing
Xian-Le Bu, +86 13635461109, buxianle@sina.cn
- Recruiting
Fujian Medical University
Fuzhou
Xiao-Chun Chen, +86 13905016998, chenxc998@163.com
- Recruiting
Southern Medical University
Guangzhou
Wei-Dong Cheng, +86 18665000116, chengweidong888@sina.com
- Recruiting
Sun Yat-sen University
Guangzhou
Ya-Mei Tang, +86 13556001992, tangym@mail.sysu.edu.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei
Xi-Ping Ding, +86 18963781399, dingxipingyx@163.com
- Recruiting
Shandong First Medical University
Jinan
Lin Song, +86 15254125957, zzusonglin@163.com
- Recruiting
Southeast University, China
Nanjing
Chun-Ming Xie, +86 13357813969, chmxie@163.com
- Recruiting
Qingdao University
Qingdao
Hui-Fu Wang, wanghuifu2010@126.com
- Recruiting
Fudan University
Shanghai
Jin-Tai Yu, +86 18678999982, jintai_yu@fudan.edu.cn
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Jian-Fang Ma, +86 13761136468, mjf10924@rjh.com.cn
- Recruiting
Shanghai University
Shanghai
Jie-Hui Jiang, +86 13918920926, jiangjiehui@shu.edu.cn
- Recruiting
Tongji University
Shanghai
Yun-Xia Li, +86 13636370312, doctorliyunxia@163.com
- Recruiting
Shenzhen Bay Laboratory
Shenzhen
Zhen Liu, +86 17685736893, liuzhen@szbl.ac.cn
- Recruiting
Shenzhen University
Shenzhen
Qing Guan, +86 18926784505, guanqing@szu.edu.cn
- Recruiting
Fudan University Taizhou Institute of Health Sciences
Taizhou
Ke-Lin Xu, +86 17717393652, xukelin@fudan.edu.cn
- Recruiting
Tianjin Medical University
Tianjin
Nan Zhang, +86 13752128310, nanzhang@tmu.edu.cn
- Recruiting
Wuhan University of Science and Technology
Wuhan
Yan Zeng, +86 15972921169, Yanzeng11@foxmail.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Kun-Mu Zheng, +86 13799781569, kumuzheng@163.com
- Recruiting
Qinghai Provincial People's Hospital
Xining
Ai-Qin Zhu, +86 13139069938, xygzrq@126.com
- Recruiting
Zhoukou Central Hospital
Zhoukou
Lei Zhang, +86 15239455777, zlzl10169033@126.com
About this study
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:
- To establish a community-based prospective cohort by recruiting over 20,000 participants from eastern, northern, southern, western, and middle regions of China.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia, Vascular Dementia (VaD), Cognitive Decline, Familial Alzheimer Disease (FAD)
- 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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Dementia, Vascular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
Secondary outcomes (27)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
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.
Measured: Baseline and follow-up assessments (up to 50 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Aug 2022
- Primary completion1 Aug 2072 (estimated)
- Study completion1 Aug 2072 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- 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, 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
- Principal investigator, Jintai Yu, Fudan University
- Investigators
- Jin-Tai Yu, MD, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912710
- Sponsor's protocol ID
- KY2022-879
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China HEalthy Aging and Dementia Study (HEAD)
- ClinicalTrials.gov ID
- NCT07912710
- Acronym / sponsor ID
- KY2022-879
- Conditions
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia, Vascular Dementia (VaD), Cognitive Decline, Familial Alzheimer Disease (FAD)
- Keywords
- China HEalthy Aging and Dementia Study, Cognitive aging, Alzheimer's disease and related dementias, Early prediction, Early diagnosis, Risk factors, Neuropsychological assessment, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- 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, 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
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2072 (estimated)
- Study completion
- 1 Aug 2072 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish a community-based prospective cohort by recruiting over 20,000 participants from eastern, northern, southern, western, and middle regions of China.
- 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.
- To conduct early prediction and diagnosis studies for ADRD and support future intervention studies based on the above-mentioned cohort and biobank.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Resident in a Chinese community.
- Aged 50-79 years.
- 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.
- Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.
- Resident in a Chinese community.
Key exclusion criteria (9 listed)
- Refusal to provide written informed consent.
- Refusal to participate in questionnaires or other data collection procedures.
- Refusal to provide blood or other biological samples.
- Self-reported stroke events (e.g., cerebral hemorrhage or cerebral infarction) within the past six months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mild cognitive impairment (MCI)
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
MCI is diagnosed according to the 2004 International Working Group (IWG) broad clinical criteria. Diagnostic status is assessed at baseline and during follow-up.
Dementia
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Mild cognitive impairment due to Alzheimer's disease (MCI due to AD)
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Dementia due to Alzheimer's disease (AD dementia)
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Mini-Mental State Examination (MMSE) total score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Montreal Cognitive Assessment (MoCA) total score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
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.
27 secondary outcomes
Auditory Verbal Learning Test (AVLT) learning score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Auditory Verbal Learning Test (AVLT) short-delay recall score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Auditory Verbal Learning Test (AVLT) long-delay recall score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Forward Digit Span Test score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Backward Digit Span Test score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Trail Making Test Part A (TMT-A) completion time
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Trail Making Test Part B (TMT-B) completion time
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Clock Drawing Test (CDT) total score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Verbal Fluency Test (VFT) total score
Time frame: Baseline and approximately annual follow-up assessments (up to 50 years)
Plasma amyloid-β 1-42 (Aβ1-42) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma amyloid-β 1-40 (Aβ1-40) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma amyloid-β 1-42/1-40 ratio (Aβ1-42/Aβ1-40)
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma phosphorylated tau 181 (p-tau181) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma phosphorylated tau 217 (p-tau217) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma total tau (t-tau) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma neurofilament light chain (NfL) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Plasma glial fibrillary acidic protein (GFAP) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid amyloid-β 1-42 (Aβ1-42) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid amyloid-β 1-40 (Aβ1-40) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid amyloid-β 1-42/1-40 ratio (Aβ1-42/Aβ1-40)
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid phosphorylated tau 181 (p-tau181) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid phosphorylated tau 217 (p-tau217) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid total tau (t-tau) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid neurofilament light chain (NfL) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebrospinal fluid glial fibrillary acidic protein (GFAP) concentration
Time frame: Baseline and follow-up assessments (up to 50 years)
Regional brain atrophy assessed by structural MRI
Time frame: Baseline and follow-up assessments (up to 50 years)
Cerebral amyloid-β burden assessed by PET
Time frame: Baseline and follow-up assessments (up to 50 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin-Tai Yu, MD, PhD study chair
Fudan University
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by Fudan University at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tai Yu, MD, PhD (+86 18678999982, jintai_yu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mild cognitive impairment (MCI) (time frame: Baseline and approximately annual follow-up assessments (up to 50 years)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.