Alzheimer's Disease
Conditions
Interventions
Observation group (Alzheimers disease):None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Study participants are between 40 and 85 years of age. 2.Study participants must provide informed consent (including broad consent for biobanking) and be willing to undergo comprehensive clinical and neuropsychological assessments. For participants lacking legal capacity, consent must be obtained from their guardian. 3.Inclusion is based on the 2018 NIA-AA criteria, requiring confirmed co-positivity for both Aß and tau pathology via CSF biomarkers or PET imaging. Specific staging criteria are: Cognitively Normal (Preclinical AD): Must have abnormal PET/CSF (Aß42/p-tau181) and objective cognitive impairment defined by Chinese MMSE (6 years education; 12 years; =1 cognitive domain, and reduced scores on Chinese MMSE (same cut-offs as CN) and MoCA (=12 years; <=21 for 7-12 years; <=18 for <=7 years). AD Dementia: Must fulfill the 2018 NIA-AA dementia criteria with abnormal PET/CSF (Aß42/p-tau181) results.
Exclusion criteria
Exclusion criteria: 1.other types of cognitive disorders; 2.central nervous system infections; 3.significant head trauma,; 4.other major neurological diseases; 5.major psychiatric disorders (e.g., schizophrenia, schizoaffective disorder); 6.intracranial masses that may impair cognition (e.g., glioma, meningioma); 7.systemic diseases that may cause cognitive deficits (e.g., multiple sclerosis, antiphospholipid antibody syndrome, Behçet's disease); 8.systemic conditions that may affect AD-related biomarker levels, including but not limited to: malignant tumors, history of myocardial infarction with cardiac dysfunction (NYHA Class III or above), chronic renal insufficiency (eGFR <30 ml/min/1.73 m²), severe hepatic impairment (Child-Pugh Class C), and active autoimmune diseases such as systemic lupus erythematosus;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cognitive subdomains;Changes in biomarkers; | — |
Countries
China
Contacts
Public ContactJintai Yu
Huashan Hospital, Fudan University
Outcome results
None listed