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Life sciences · Observational Study
ClinicalTrials.gov · November 3, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07912710). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 20000 participants (ESTIMATED). Conditions: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia, Vascular Dementia (VaD), Cognitive Decline, Familial Alzheimer Disease (FAD), Non-Alzheimer Degenerative Dementia. Primary outcome measures: Mild cognitive impairment (MCI) , Baseline and approximately annual follow-up assessments (up to 50 years); Dementia , Baseline and approximately annual follow-up assessments (up to 50 years); Mild cognitive impairment due to Alzheimer's disease (MCI due to AD) , Baseline and approximately annual follow-up assessments (up to 50 years); Dementia due to Alzheimer's disease (AD dementia) , Baseline and approximately annual follow-up assessments (up to 50 years); Mini-Mental State Examination (MMSE) total score , Baseline and approximately annual follow-up assessments (up to 50 years); Montreal Cognitive Assessment (MoCA) total score , Baseline and approximately annual follow-up assessments (up to 50 years); Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score , Baseline and approximately annual follow-up assessments (up to 50 years). Brief 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.