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Clinical Trials/NCT06477484
NCT06477484
Recruiting
Not Applicable

Blood-based Biomarkers for Early Alzheimer's Disease Screening

Peking University First Hospital1 site in 1 country180 target enrollmentJune 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Peking University First Hospital
Enrollment
180
Locations
1
Primary Endpoint
Evaluate the diagnostic accuracy of blood biomarkers of Aβ42, Aβ40, Aβ42/Aβ40, P-Tau181, P-Tau217, GFAP and NfL.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to estimate the screen performance of blood biomarkers of interest (Aβ40 and Aβ42, P-Tau181, P-Tau217, GFAP and NfL) in patients with Alzheimer's disease (AD), mild cognitive impairment due to AD, and cognitively normal individuals. The main questions it aims to answer are:

  • to identify core blood biomarker suitable for early screening of AD.
  • to establish a comprehensive model for the early identification of AD.
Registry
clinicaltrials.gov
Start Date
June 18, 2024
End Date
March 26, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 50 years;
  • AD (meets the 2011 NIA-AA AD diagnostic criteria), or MCI (meets the 2004 Peterson MCI diagnostic criteria), or cognitively normal subjects;
  • Signed informed consent form.

Exclusion Criteria

  • The presence of other disorders that can cause cognitive impairment;
  • Unable to cooperate with the completion of cognitive assessment;
  • Refusal to draw blood.

Outcomes

Primary Outcomes

Evaluate the diagnostic accuracy of blood biomarkers of Aβ42, Aβ40, Aβ42/Aβ40, P-Tau181, P-Tau217, GFAP and NfL.

Time Frame: 2 years

Secondary Outcomes

  • Evaluate the diagnostic accuracy of a comprehensive model combined with core blood biomarkers and clinical information.(2 years)

Study Sites (1)

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