Status:
ENROLLING_BY_INVITATION
Clinical Evaluation of Blood-Based Assays for Rapid Detection of Aβ Pathology in Alzheimer's Disease
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Alzheimer's Disease Diagnosis
Eligibility:
All Genders
45-85 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06889896
Start Date
July 11 2024
End Date
August 1 2025
Last Update
March 21 2025
Active Locations (1)
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1
Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Hefei, Anhui, China, 230000