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Lacrimal biomarkers in Early Alzheimer's Diagnosis

Lacrimal biomarkers in Early Alzheimer's Diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102088
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-05-16
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease

Interventions

Gold Standard:Positron emission tomography (PET) imaging and CSF biomarker detection
Index test:Expression levels of specific protein biomarkers (Aß and tau proteins) in tears

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Adults over 35 years of age who complain of cognitive impairment; 2.Able to cooperate in providing tear samples. 3.Able to cooperate with the completion of the Alzheimer's disease diagnosis process. Biomarkers of Alzheimer's disease include blood ptau217 rise/CSFAß42/40 or Aß42 decline with or without ptau181 and total tau/Aß-PET-CT suggesting amyloid deposition in brain tissue; 4.It can be used in conjunction with other clinical and imaging examinations; 5.The patient or their family member signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Unable to cooperate with the examination staff. 2.Patients with cognitive impairment secondary to central nervous system infections (such as HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (such as diabetes, thyroid dysfunction); 3.Patients with cognitive impairment secondary to ocular diseases that may affect tear biochemical parameters (including ocular infections, ocular inflammation, or other acute ocular diseases); 4.Patients with significant dysfunction of major organs such as the heart, lungs, liver, or kidneys.

Design outcomes

Primary

MeasureTime frame
The ability of tear biomarkers to distinguish between Alzheimer's disease (AD) and non-AD populations (Area Under Curve, AUC);Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Correlation between tear markers and retinal and choroidal OCTA blood flow parameters;Differences in tear marker levels between AD patients and non-AD patients, as well as between patients with varying degrees within the AD group;

Countries

China

Contacts

Public ContactSheng Zhang

Zhejiang Provincial People's Hospital

zhangsheng@hmc.edu.cn+86 187 5818 8313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026