An observational study in Alzheimer's Disease Diagnosis, sponsored by Anhui Provincial Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Anhui Provincial Hospital · Observational
Background: Blood-based biomarkers show promise in predicting Alzheimer's disease (AD) pathology and progression; however, inconsistencies in detection standards hinder clinical application. A head-to-head comparison of commercially available biomarkers is crucial for optimizing the clinical pathway for AD screening and diagnosis.
Method: The CLEAR-AD study is an ongoing population-based cross-sectional study, currently recruiting 400 participants in ten centers in China. The study includes cognitively normal controls, individuals with mild cognitive impairment (MCI) - categorized as amyloid-positive and amyloid-negative - as well as patients with dementia, also divided into amyloid-positive and amyloid-negative groups. All participants undergo amyloid PET scans using tracers such as AV1, AV45, and PIB. Blood samples are collected within three months prior to the PET scan or from existing samples collected after January 1, 2024, that meet quality standards. After collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau181/217. The detection technologies included single-molecule immunoassay, digital immunoassay chips, magnetic particle chemiluminescence, and flow cytometry fluorescence. The objective is to assess the sensitivity and specificity of different plasma biomarker levels in predicting amyloid pathology confirmed by Aβ-PET.
Result: The study uses Aβ-PET as the reference standard to evaluate the sensitivity and specificity of various AD plasma biomarkers across different detection methods in diagnosing amyloid pathology. The analysis included generating receiver operating characteristic (ROC) curves, determining optimal cut-off values, and developing a predictive model that integrates multiple biomarker parameters and clinical data. Results is considered statistically significant with a p-value of less than 0.05.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
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The CLEAR-AD study is an ongoing population-based cross-sectional study, currently recruiting 400 participants in ten centers in China. The study includes cognitively normal controls, individuals with mild cognitive impairment (MCI) - categorized as amyloid-positive and amyloid-negative - as well as patients with dementia, also divided into amyloid-positive and amyloid-negative groups. All participants undergo amyloid PET scans using tracers such as AV1, AV45, and PIB.
Patient Group (including MCI, AD, and Non-AD Dementia):
Normal Control Group:
Exclusion Criteria:
There are clear complaints of cognitive impairment, and the diagnoses of AD meet the NIA-AA 2011 diagnostic criteria.
Diagnostic Test: After Blood samples collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau
There are clear complaints of cognitive impairment, and the diagnoses of MCI meet the NIA-AA 2011 diagnostic criteria. Amyloid protein PET indicated positive within the last 3 months."
Diagnostic Test: After Blood samples collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau
There are clear complaints of cognitive impairment, and the diagnoses of MCI meet the NIA-AA 2011 diagnostic criteria.Amyloid protein PET indicated negative within the last 3 months
Diagnostic Test: After Blood samples collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau
Non-AD dementia is defined as patients who have a decline in cognitive abilities but are diagnosed with dementia due to other reasons (including but not limited to FTD, DLB, VD, PDD, etc.
Diagnostic Test: After Blood samples collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau
No complaints of cognitive impairment, scores within the normal range, and amyloid protein PET negative
Diagnostic Test: After Blood samples collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau
The CLEAR-AD study is an ongoing population-based cross-sectional study, currently recruiting 400 participants in ten centers in China. The study includes cognitively normal controls, individuals with mild cognitive impairment (MCI) - categorized as amyloid-positive and amyloid-negative - as well as patients with dementia, also divided into amyloid-positive and amyloid-negative groups. All participants undergo amyloid PET scans using tracers such as AV1, AV45, and PIB. Blood samples are collected within three months prior to the PET scan or from existing samples collected after January 1, 2024, that meet quality standards. After collection, these samples are analyzed at a central laboratory under blinded conditions using multiple detection methods to measure plasma levels of Aβ40, Aβ42, t-tau, and p-tau181/217. The detection technologies included single-molecule immunoassay, digital immunoassay chips, magnetic particle chemiluminescence, and flow cytometry fluorescence. The objective i
Evaluate the sensitivity and specificity of blood biomarkers in predicting amyloid pathology confirmed by Aβ-PET under different testing methods
Time frame: 2025.08
Plan to share: No — All interested researchers can obtain relevant information through the contact details of the researchers
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Anhui Provincial Hospital