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Research on the Application of Alzheimer’s Disease Blood Biomarkers in Clinical Testing and the Construction of Related Predictive Models

Research on the Application of Alzheimer’s Disease Blood Biomarkers in Clinical Testing and the Construction of Related Predictive Models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121882
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Alzheimer’s disease

Interventions

Gold Standard:The patient has a clear complaint of cognitive decline. The diagnosis of Mild Cognitive Impairment (MCI) meets the NIA-AA 2011 diagnostic criteria. The diagnosis of Alzheimer's Disease (
Index test:The levels of p-tau217 and p-tau181 were measured in patients’ EDTA plasma.PCR-based assays were used to identify the most common alleles (e2, e3, e4).ApoE4 zygosity classification was dete

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.The samples are from the sample bank and have previously signed a broad informed consent form. 2.Participants were aged between 50 and 90 years; 3.PET results; 4.The subjects had undergone comprehensive clinical and neuropsychological assessments, including MMSE, MoCA, and CDR.

Exclusion criteria

Exclusion criteria: 1.Cognitive dysfunction or dementia caused by any non-AD diseases, including other neurodegenerative disorders (e.g., Lewy body dementia, frontotemporal dementia, Huntington's disease, Parkinson's disease, etc.), and non-neurodegenerative neurological conditions (e.g., vascular cognitive impairment or dementia, hydrocephalus, syphilis, encephalitis, hypoxic brain injury, traumatic brain injury, etc.); 2.cognitive dysfunction or dementia caused by non-neurological diseases, including endocrine disorders (e.g., hypothyroidism), hepatic insufficiency, pulmonary encephalopathy, dialysis encephalopathy, etc.; 3.Exclusion of toxic diseases (including alcoholism, drug dependence/abuse, delayed carbon monoxide encephalopathy, etc.); 4.Eliminate vitamin deficiencies (e.g., B12 deficiency, B1 deficiency, etc.) that may cause cognitive dysfunction or dementia; 5.Avoid testing for lipemia/hemolysis in samples;

Design outcomes

Primary

MeasureTime frame
The correlation p-tau217 and p-tau181 in the classification accuracy reflecting the status of ß-amyloid positive.;p-tau217 in the classification accuracy reflecting the status of ß-amyloid pathology.;p-tau181 in the classification accuracy reflecting the status of ß-amyloid pathology.;

Secondary

MeasureTime frame
The correlation between plasma ApoE4 zygosity classification and APOE genotyping.;

Countries

China

Contacts

Public ContactXia Yong

Peking University Shenzhen Hospital

sunmoonrain78@163.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026