Alzheimer's Disease DiagnosisCLEAR ADNCT06889896
Clinical Evaluation of Blood-Based Assays for Rapid Detection of Aβ Pathology in Alzheimer's Disease
An observational study of Alzheimer's Disease Diagnosis, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Background: Blood-based biomarkers show promise in predicting Alzheimer's disease (AD) pathology and progression; however, inconsistencies in detection standards hinder clinical application. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease Diagnosis
- What is being tested?
- 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
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patient Group (including MCI, AD, and Non-AD Dementia):
- Clear complaints of cognitive impairment, with MCI and AD diagnoses meeting the NIA-AA 2011 diagnostic criteria. Non-AD dementia is defined as patients with cognitive decline diagnosed with dementia due to other reasons (including but not limited to FTD, DLB, VD, PDD, etc.).
- Able to provide informed consent or have a legal guardian who can sign the consent form.
- Completed a full set of cognitive assessments, including MMSE and CDR.
- Able to provide a history of chronic diseases, including cardiovascular diseases, diabetes, etc., and medication history.
- Have undergone amyloid protein PET scans that meet the quality requirements of this study (tracers PiB, AV1, or AV45), and can provide original imaging data for quantitative analysis without conflict.
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- Can provide frozen plasma from a biobank collected after January 1, 2024, with a time interval of ≤3 months from the amyloid protein PET scan. If no frozen plasma is available, willing to provide an additional 5ml of whole blood for biomarker testing in this project. The process of blood collection, plasma separation, storage, and transportation meets the quality requirements of this study (see blood testing SOP).
- Have 3D-T1 structural MRI images taken within 3 months before and after the amyloid protein PET scan and can provide original imaging data without conflict.
- Normal Control Group:
- Subjects with a CDR score of 0 and who have undergone amyloid protein PET scans that are negative.
- Able to provide informed consent.
- Completed a full set of cognitive assessments, including MMSE and CDR.
- Able to provide a history of chronic diseases, including cardiovascular diseases, diabetes, etc., and medication history.
- Have undergone amyloid protein PET scans that meet the quality requirements of this study (tracers PiB, AV1, or AV45), and can provide original imaging data for quantitative analysis without conflict.
- Can provide frozen plasma from a biobank collected after January 1, 2024, with a time interval of ≤3 months from the amyloid protein PET scan. If no frozen plasma is available, willing to provide an additional 5ml of whole blood for biomarker testing in this project. The process of blood collection, plasma separation, storage, and transportation meets the quality requirements of this study (see blood testing SOP).
- Have 3D-T1 structural MRI images taken within 3 months before and after the amyloid protein PET scan and can provide original imaging data without conflict.
Who cannot join
- History of Mental Illness:** Depression (Geriatric Depression Scale [GDS] > 7 points or Hamilton Depression Rating Scale [17-item version] > 7 points);
- History of Central Nervous System Diseases:** Including infections, epilepsy, multiple sclerosis, toxic metabolic diseases, familial hereditary diseases, neurotumors, etc.;
- Severe Stroke Sequelae:** mRS > 3 points or a documented history of stroke sequelae;
- Severe Liver and Kidney Dysfunction at Diagnosis:** ALT ≥ 5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml·min-¹·(1.73 m²)-¹, or patients requiring renal replacement therapy;
- History of Drug Abuse and Severe Alcoholism;**
- Prior Use of Anti-Aβ or Other Disease-Modifying Treatments,** unless there is clear evidence of a placebo group;
- Severe Hyperlipidemia:** Triglycerides ≥ 5.6 mmol/L or visible chylomicron changes in plasma.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Hefei, Anhui, 230000
About this study
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.
- Conditions
- Alzheimer's Disease Diagnosis
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-tauDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| AD | There are clear complaints of cognitive impairment, and the diagnoses of AD meet the NIA-AA 2011 diagnostic criteria. Receives: 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 | |
| MCI（Aβ PET+） | 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." Receives: 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 | |
| MCI（Aβ PET-） | 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 Receives: 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 | 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. Receives: 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 | |
| Cognitively normal controls | No complaints of cognitive impairment, scores within the normal range, and amyloid protein PET negative Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of blood biomarkers in predicting amyloid pathology confirmed by Aβ-PET under different testing methods
Measured: 2025.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease DiagnosisStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889896
- Sponsor's protocol ID
- 2024KY305
- Acronym
- CLEAR AD
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All interested researchers can obtain relevant information through the contact details of the researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Blood-Based Assays for Rapid Detection of Aβ Pathology in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06889896
- Acronym / sponsor ID
- CLEAR AD / 2024KY305
- Conditions
- Alzheimer's Disease Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 21 Mar 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AD | – | 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-tauThere are clear complaints of cognitive impairment, and the diagnoses of AD meet the NIA-AA 2011 diagnostic criteria. |
| MCI（Aβ PET+） | – | 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-tauThere 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." |
| MCI（Aβ PET-） | – | 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-tauThere 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 |
| Non-AD dementia | – | 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-tauNon-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. |
| Cognitively normal controls | – | 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-tauNo complaints of cognitive impairment, scores within the normal range, and amyloid protein PET negative |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- Clear complaints of cognitive impairment, with MCI and AD diagnoses meeting the NIA-AA 2011 diagnostic criteria. Non-AD dementia is defined as patients with cognitive decline diagnosed with dementia due to other reasons (including but not limited to FTD, DLB, VD, PDD, etc.).
- Able to provide informed consent or have a legal guardian who can sign the consent form.
- Completed a full set of cognitive assessments, including MMSE and CDR.
- Able to provide a history of chronic diseases, including cardiovascular diseases, diabetes, etc., and medication history.
- Have undergone amyloid protein PET scans that meet the quality requirements of this study (tracers PiB, AV1, or AV45), and can provide original imaging data for quantitative analysis without conflict.
Key exclusion criteria (7 listed)
- History of Mental Illness:** Depression (Geriatric Depression Scale [GDS] > 7 points or Hamilton Depression Rating Scale [17-item version] > 7 points);
- History of Central Nervous System Diseases:** Including infections, epilepsy, multiple sclerosis, toxic metabolic diseases, familial hereditary diseases, neurotumors, etc.;
- Severe Stroke Sequelae:** mRS > 3 points or a documented history of stroke sequelae;
- Severe Liver and Kidney Dysfunction at Diagnosis:** ALT ≥ 5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml·min-¹·(1.73 m²)-¹, or patients requiring renal replacement therapy;
- History of Drug Abuse and Severe Alcoholism;**
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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-tauThe 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 | Diagnostic test | AD, Cognitively normal controls, MCI（Aβ PET+）, MCI（Aβ PET-）, Non-AD dementia |
Primary outcome
Evaluate the sensitivity and specificity of blood biomarkers in predicting amyloid pathology confirmed by Aβ-PET under different testing methods
Time frame: 2025.08
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No. All interested researchers can obtain relevant information through the contact details of the researchers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease Diagnosis, run by Anhui Provincial Hospital at 1 site 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 16 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sensitivity and specificity of blood biomarkers in predicting amyloid pathology confirmed by Aβ-PET under different testing methods (time frame: 2025.08). 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 21 Mar 2025.