NCT06477484RecruitingNot Applicable
Blood-based Biomarkers for Early Alzheimer's Disease Screening
Peking University First Hospital1 site in 1 country180 target enrollmentStarted: June 18, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- 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.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Study Sites (1)
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