Alzheimers disease
Conditions
Interventions
Gold Standard:The criteria are based on the *Diagnostic and Statistical Manual of Mental Disorders, 5th Edition* (DSM-5) and the NIA-AA clinical diagnostic criteria
Index test:A combined diagnostic model incorporating retinal and choroidal structures (such as retinal thickness across different layers, retinal vascular density in the macular region, and choroidal
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Available cerebrospinal fluid, PET, CT or MRI data to assess the presence or absence of neurodegenerative disease (preferably obtained within one year of enrolment in this study); 2. OCT/OCTA image quality score (0–10) >= 7; 3. No ocular conditions likely to affect tear biochemistry parameters (including ocular infections, ocular inflammation, ocular surgery within the previous 28 days, or other acute ocular conditions); 4. Written informed consent obtained and on file; 5. Age > 50 years; 6. No indications of inability to undergo follow-up (up to 12 months); 7. Additional inclusion criteria for MCI/AD: The clinical diagnosis of dementia will be based on the criteria for Major Neurocognitive Disorder in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), in conjunction with the National Institute on Ageing–Alzheimer’s Association (NIA-AA) clinical diagnostic criteria, and the patient must be capable of providing informed consent (Mini-Mental State Examination (MMSE) score > 17/30). The diagnosis of MCI requires that patients exhibit impaired cognitive function but retain the ability to perform activities of daily living, consequently, they cannot be diagnosed with AD; 8. Additional inclusion criteria for cognitively healthy controls: baseline MMSE score of 26–30, no history of cognitive impairment or treatment, and no current or past history of seeking help for cognitive problems.
Exclusion criteria
Exclusion criteria: 1. Patients with other neurological conditions (such as Huntington’s disease or multiple sclerosis); 2. Patients with diabetes, kidney disease or other systemic conditions affecting choroidal circulation; 3. Patients on long-term steroid therapy; 4. Patients with eye conditions that may affect tear composition (such as eye infections, inflammation or eye surgery within the past 28 days); 5. Patients in a life-threatening critical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of tear biomarkers (Phosphorylated Tau, Amyloid-beta, Neurofilament light chain);Changes in the structural parameters of the fundus (retina and choroid); | — |
Secondary
| Measure | Time frame |
|---|---|
| area under the receiver operating characteristic curve (AUC);Sensitivity;accuracy;specificity; | — |
Countries
China
Contacts
Public ContactJin Li
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed