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CompletedNCT06477484Updated Sep 28, 2026

Blood Biomarkers for Screening of Alzheimer's Disease

An observational study in Alzheimer's Disease and Blood Biomarkers, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Peking University First Hospital · Observational

Updated Sep 28, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
180
Ages
50 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Alzheimer's Disease
  • Blood Biomarkers

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 180 is close to the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Alzheimer's disease, mild cognitive impairment due to AD, and cognitively normal individuals.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • different stages of individuals with Alzheimer's disease

    Diagnostic Test: Blood biomarker

Interventions

  • Diagnostic testBlood biomarker

    Blood biomarker

06

What researchers measure

Primary outcomes

  1. 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

  1. Evaluate the diagnostic accuracy of a comprehensive model combined with core blood biomarkers and clinical information.

    Time frame: 2 years

07

Study locations

1 site
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 28, 2026
Sites
1 site added, 1 site removed
Show site
  • Peking University First Hospital · Beijing, China
Show 1 removed
  • Peking University First Hospital · Beijing, China
Sep 28, 2026
Start date
Jun 18, 2024→Jun 10, 2024
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Peking University First Hospital · Beijing, China
    Show 1 removed
    • Peking University First Hospital · Beijing, China
    Start date Jun 18, 2024→Jun 10, 2024
    + 2 other changes: index terms and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06477484
Lead sponsor
Peking University First Hospital
Responsible party
Sponsor
First posted
Jun 27, 2024
Start date
Jun 10, 2024
Primary completion
Mar 26, 2026
Completion
Mar 26, 2026
Last update
Sep 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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