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Diagnostic efficacy of blood biomarkers in different stages of Alzheimer's disease

Diagnostic efficacy of blood biomarkers in different stages of Alzheimer's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092226
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-11-18

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 AD group was divided into 6 stages according to the contents of the 2018 NIA-AA Biological Definition of Alzheimers disease research framework, that is, into 6 groups, each group =20
Index test:Human plasma Aß1-42, Aß1-40, p-Tau181, p-Tau217, NfL, GFAP were detected. The t

Sponsors

Sanbo Brain Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) All subjects were =18 years old. (2) The AD group met the diagnostic criteria of the NIA-AA Revised Draft Guidelines for the Diagnosis of Alzheimer's Disease (2023 edition) : the presence of any abnormal core AD biomarker, namely fluid Aß42/40, p-Tau181, p-Tau 217, amyloid PET, or Tau PET, combined with clinical diagnosis. (3) Complete medical history, scale, body fluid markers or imaging data can support the diagnosis of AD and the stage of cognitive function. (4) The healthy control group had no history of neuropsychiatric diseases, no manifestations of cognitive impairment and central nervous system diseases, and the core AD biomarkers were negative. (5) The subject himself or his family members sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) The subject's sample has severe hemolysis, lipemia or turbidity; (2) If patients take Aß and tau-related antibody drugs, the antibody drugs may combine with the tested substance and interfere with the test results, and the test can only be detected after A certain period of drug withdrawal, and the specific withdrawal period needs to be confirmed by clinicians according to pharmacokinetics.

Design outcomes

Primary

MeasureTime frame
Aß1-42/Aß1-40;p-Tau181;p-Tau217;NfL;GFAP;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactChen Shengyun

Sanbo Brain Hospital, Capital Medical University

csywindy@163.com+86 137 0109 0481

Outcome results

None listed

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