Alzheimers disease (AD)
Conditions
Interventions
Gold Standard:-Clinical Diagnostic Standard: Core clinical diagnostic criteria for Alzheimers disease (AD) established by the National Institute on Aging–Alzheimer's Association (NIA-AA)
-PET Diagnost
Index test:chemiluminescence immunoassay (CLIA) to measure peripheral blood biomarkers, including Aß1-40?Aß1-42?p-Tau-231?p-Tau-181?p-Tau-217?p-Tau-205?MTBR-tau243?NFL?GFAP etc.
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Cognitively Normal Controls: [1] Aged 50-85 years (inclusive), any gender; [2] Minimum elementary school education with ability to complete protocol-specified cognitive assessments; [3] No cognitive impairment; [4] Clinical Dementia Rating (CDR) = 0; [5] Mini-Mental State Examination (MMSE) score 27-30; [6] Hachinski Ischemic Score (HIS) 1.5cm, - No lacunes in critical areas (thalamus, hippocampus, entorhinal/parahippocampal cortices, or cortical/subcortical gray nuclei); [10] Signed informed consent before protocol-related procedures. 2. Inclusion Criteria for Alzheimer's Disease (AD) Patients: A. Probable AD Clinical Diagnosis Criteria: [1] Aged 50-85 years (inclusive), any gender; [2] Minimum elementary school education with ability to complete protocol-specified cognitive assessments; [3] Documented memory decline for >= 12 months with progressive worsening; [4] Meets NIA-AA core clinical criteria for probable AD; [5] Clinical Dementia Rating (CDR) >= 0.5; [6] Hachinski Ischemic Score (HIS) 1.5cm, - Absence of lacunes in critical regions (thalamus, hippocampus, entorhinal/parahippocampal cortices, or cortical/subcortical gray nuclei); [9] No significant neurological signs on examination; [10] Written informed consent from participant or legal guardian (if cognitive impairment precludes self-consent). B. Biomarker-Confirmed AD Criteria: [1] Fulfills all probable AD criteria above; [2] Positive Florbetapir-PET (AV-45) amyloid scan. 3. Inclusion Criteria for Non-Alzheimer's Cognitive Impairment: [1] Aged 50-85 years (inclusive), any gender; [2] Minimum elementary school education with ability to complete protocol-specified cognitive assessments; [3] Clinical Dementia Rating (CDR) >= 0.5; [4] Clinically diagnosed with either: a) Non-AD neurodegenerative disorders: - Frontotemporal dementia (FTD) - Parkinson's disease dementia (PDD) - Dementia with Lewy bodies (DLB) - Progressive supranuclear palsy (PSP) - Corticobasal degeneration (CBD), or b) Cerebral small vessel disease (CSVD); [5] Written informed consent from participant or legal guardian (if cognitive impairment precludes self-consent).
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Cognitively Normal Controls: [1] Contraindications to brain MRI at screening; [2] History of neurological disorders (stroke, neuromyelitis optica, Parkinson’s disease, epilepsy, etc.); [3] Visual/hearing impairment preventing neuropsychological testing; [4] Alcohol or substance abuse; [5] Psychiatric disorders (including major depressive disorder); [6] Myocardial infarction, unstable angina, severe coronary artery disease, or NYHA Class III/IV heart failure within 12 months; [7] Uncontrolled hypertension (SBP >160 mmHg or DBP >95 mmHg) or hypotension (SBP 2.5×ULN; - Vitamin B12 deficiency (<LLN); - HIV-positive status or confirmed at screening; - History/screening-positive neurosyphilis (RPR test); [9] History of cancer/malignant tumors; [10] Severe/unstable chronic systemic diseases per investigator judgment; [11] Pregnant (urine test-confirmed) or lactating women. 2. Exclusion Criteria for Alzheimer's Disease Patients: [1] Any medical or physical contraindications to brain MRI at screening; [2] Other potential causes of cognitive impairment including but not limited to: Other neurodegenerative disorders (frontotemporal dementia, Parkinson's disease dementia, dementia with Lewy bodies, PSP, CBD, etc.) Vascular cognitive impairment CNS infections (e.g., neurosyphilis, HIV/AIDS) Prion diseases (e.g., Creutzfeldt-Jakob disease) Huntington's disease Post-traumatic dementia Toxic/metabolic causes (drug/alcohol/CO intoxication) Systemic disorders (hepatic/pulmonary encephalopathy) Intracranial space-occupying lesions (subdural hematoma, brain tumors) Endocrine disorders (thyroid/parathyroid diseases) Vitamin deficiency Any other conditions potentially causing cognitive impairment; [3] Psychiatric disorders per DSM-5 criteria: Schizophrenia or other psychotic disorders Bipolar disorder Major depressive disorder Delirium; [4] Other severe systemic diseases; [5] Uncorrectable visual/auditory impairment preventing neuropsychological testing; [6] Alcohol or substance abuse; [7] Currently lactating or pregnant women (confirmed by urine test). 3. Exclusion Criteria for Non-Alzheimer's Cognitive Impairment: [1] Any contraindications to brain MRI examination at screening; [2] Other potential causes of cognitive impairment EXCEPT the clinically diagnosed non-AD neurodegenerative disorders (FTD, PDD, DLB, PSP, CBD, etc.) or CSVD, including but not limited to: Alzheimer's disease CNS infections (neurosyphilis, HIV/AIDS, etc.) Prion diseases (e.g., Creutzfeldt-Jakob disease) Huntington's disease Post-traumatic dementia Toxic/metabolic causes (drug/alcohol/CO intoxication) Severe systemic diseases (hepatic/pulmonary encephalopathy) Intracranial space-occupying lesions (subdural hematoma, brain tumors) Endocrine disorders (thyroid/parathyroid diseases) Vitamin deficiencies Any other conditions that may cause cognitive impairment; [3] Psychiatric disorders per DSM-5 criteria: Schizophrenia or other psychotic disorders Bipolar disorder Major depressive disorder Delirium; [4] Other severe systemic diseases; [5] Uncorrectable visual/auditory impairment preventing neuropsychological testing; [6] Alcohol or substance abuse; [7] Currently lactating or pregnant women (confirmed by urine test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s Disease-Related Peripheral Blood Biomarkers;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive Status; | — |
Countries
China
Contacts
Public ContactXu Qun
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed