An observational study in Dementia, Alzheimer Dementia (AD) and Mild Cognitive Impairment (MCI), sponsored by Fujian Medical University Union Hospital. Recruiting at 4 sites in China. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Fujian Medical University Union Hospital · Observational
The goal of this observational study is to learn about the pathophysiological characterization and evolutionary patterns of Alzheimer's disease (AD) in older adults in Fujian Province, China. The primary purposes are as follows:
Alzheimer's disease (AD) represents a major public health challenge in China's aging society, and early screening and intervention are key to reducing the incidence of AD dementia. This project, in collaboration with multiple community health service centers in Fujian Province, China, aims to establish a retrospective and prospective, multi-center AD cohort. We plan to enroll approximately 3,000 elderly volunteers and collect comprehensive baseline and longitudinal follow-up data, including multi-dimensional digital-intelligence screening, plasma/cerebrospinal fluid biomarkers (Aβ42/Aβ40, p-Tau217, NfL, GFAP, sTREM2, etc.), APOE genotyping, electroencephalographic features, multi-modal MRI, and Aβ/tau PET imaging.
All participants will undergo cognitive assessment, genetic screening, and blood sample collection. Some participants will also undergo cerebrospinal fluid (CSF) collection, electroencephalography (EEG), digital cognitive testing, MRI scans, Aβ PET scans, and tau PET scans. Annual follow-up will be conducted for all participants.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 250 across 500 observational studies indexed under Dementia.
Browse Dementia studies →Fujian Medical University Union Hospital is the lead sponsor of 104 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants meeting NIA-AA 2024 criteria for probable AD dementia. Included for multi-modal data validation and characterization of late-stage disease features.
Diagnostic Test: Fluids biomarker and neuroimaging of AD diagnosis
Early diagnosis of Alzheimer's disease using fluids biomarker and neuroimaging.
Longitudinal cognitive function _ Clinical Dementia Rating
Clinical Dementia Rating (CDR). The CDR is used to assess cognitive and functional performance. Scores range from 0 to 3, where 0 indicates no dementia, 0.5 indicates questionable dementia, and higher scores (1, 2, 3) indicate mild, moderate, and severe dementia, respectively. Higher scores indicate a worse outcome.
Time frame: through study completion, an average of 1 year
Longitudinal changes of cognitive function _ Montreal Cognitive Assessment Basic
Montreal Cognitive Assessment Basic (MoCA-Basic). The MoCA-Basic is a cognitive screening tool with a total score ranging from 0 to 30. Higher scores indicate better cognitive function, while lower scores indicate a worse outcome.
Time frame: through study completion, an average of 1 year
Longitudinal changes of cognitive function _ Mini-mental State Examination, the Chinese version
Mini-mental State Examination (MMSE, Chinese version). The MMSE is a 30-point questionnaire used to assess cognitive impairment. Scores range from 0 to 30. Higher scores indicate better cognitive function, while lower scores indicate a worse outcome (more severe cognitive impairment).
Time frame: through study completion, an average of 1 year
Longitudinal changes of cognitive function _ Alzheimer's Disease Assessment Scale - Cognitive Subscale
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). The ADAS-Cog is a 70-point scale used to assess cognitive function in Alzheimer's disease. Scores range from 0 to 70. Higher scores indicate a worse outcome (more severe cognitive impairment).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _ Neuropsychiatric Inventory
Neuropsychiatric Inventory (NPI). The NPI is a 144-point scale used to assess neuropsychiatric symptoms in patients with dementia. Scores range from 0 to 144. Higher scores indicate a worse outcome (more severe neuropsychiatric symptoms).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _ Geriatric Depression Scale
Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item scale used to assess depression in older adults. Scores range from 0 to 15. Higher scores indicate a worse outcome (more severe depressive symptoms).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _ Function Activities Questionnaire
Function Activities Questionnaire (FAQ). The FAQ is a 30-point scale used to assess functional activities in older adults. Scores range from 0 to 30. Higher scores indicate a worse outcome (greater functional impairment/dependency).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _Activity of Daily Living Scale
Activity of Daily Living Scale (ADL). The ADL scale is a 20-item instrument used to assess functional independence in daily living activities, including both basic ADL and instrumental ADL (IADL). Scores range from 20 to 80. Lower scores indicate a better outcome (greater independence), while higher scores indicate a worse outcome (greater dependency).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 21-point scale used to assess sleep quality and disturbances over a 1-month interval. Scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Time frame: through study completion, an average of 1 year
Longitudinal functional and behavioral function _ REM Sleep Behavior Disorder Screening Questionnaire
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). The RBDSQ is a 13-point self-rating questionnaire used to screen for REM sleep behavior disorder. Scores range from 0 to 13, with higher scores indicating a worse outcome (greater likelihood of RBD).
Time frame: through study completion, an average of 1 year
Longitudinal changes of plasma biomarkers
Longitudinal changes of disease status as categorized by plasma biomarkers of Alzheimer's diseases over time.
Time frame: through study completion, an average of 1 year
Longitudinal changes of cerebrospinal fluid biomarkers
Longitudinal changes of disease status as categorized by cerebrospinal fluid (CSF) biomarkers of Alzheimer's diseases over time.
Time frame: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Magnetic Resonance Imaging
Longitudinal change in brain structure using magnetic resonance imaging (MRI)
Time frame: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Amyloid PET images
Longitudinal changes in amyloid deposition
Time frame: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Tau PET images
Longitudinal changes in tau deposition
Time frame: through study completion, an average of 1 year
Longitudinal changes in Electroencephalogram Features
Longitudinal Changes in AD-Related Electroencephalogram (EEG) Features
Time frame: through study completion, an average of 1 year
Longitudinal changes in digital cognitive phenotype
Based on multimodal data including eye tracking (fixation duration, saccadic velocity, pupillary response), behavioral responses (reaction time, accuracy, task completion patterns), and spatial navigation (path efficiency, spatial memory error), construct a digital cognitive phenotype of AD and investigate the longitudinal changes in the digital cognitive phenotype.
Time frame: through study completion, an average of 1 year
Correlation of the Evolutionary Patterns of AD Pathological Features
To explore the associations between parameters such as genetic factors, environmental factors, neuroimmune factors, and cerebrovascular factors and plasma markers as well as the aggregation of Aβ plaques and tau tangles in the cerebral cortex.
Time frame: through study completion, an average of 1 year
Correlation of AD Risk Genes and Their Mechanisms of Action
To investigate the relationships between genetic susceptibility genes and AD pathological features and disease evolution.
Time frame: through study completion, an average of 1 year
Distribution and Carrier Status of AD Genetic Susceptibility Genes and Risk Loci
To observe the distribution and carrier status of AD genetic susceptibility genes and risk loci. Carrier status will be reported as positive or negative for specific risk alleles (e.g., APOE4).
Time frame: Baseline
Correlation of Biomarkers and PET Molecular Imaging
To evaluate the efficacy of plasma/cerebrospinal fluid biomarkers, Aβ PET, tau PET, and digital-intelligent screening indicators in the early diagnosis, staging, and progression prediction of AD.
Time frame: through study completion, an average of 1 year
Genetic Susceptibility Genes and Indicators Related to AD Pathogenesis in Individuals with a Positive Family History
To investigate the genetic susceptibility genes and indicators related to AD pathogenesis in individuals with a positive family history. Genetic variants will be reported as genotype frequencies and odds ratios.
Time frame: Baseline
Correlation Between Digital-Intelligent Screening Indicators and AD Pathological Features
To evaluate the concurrent validity, test-retest reliability, and discriminant validity of multidimensional digital-intelligent screening in the elderly population, and to determine its optimal threshold scores and sensitivity/specificity; to analyze the correlations between digital-intelligent screening indicators and plasma markers as well as indicators such as Aβ PET and tau PET.
Time frame: through study completion, an average of 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Aug 2036, 151 months after the start.
Of 235 non-industry observational studies under Dementia, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 208. This study's planned 151 months is above that.
Counting every sponsor, half of 256 studies reached it within 81 months; a quarter within 29 and three quarters within 203.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fujian Medical University Union Hospital →