NCT06477484

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

June 18, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2026

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

June 6, 2024

Last Update Submit

June 26, 2024

Conditions

Alzheimer's DiseaseBlood Biomarkers

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (1)

different stages of individuals with Alzheimer's disease

Diagnostic Test: Blood biomarker

Interventions

Blood biomarkerDIAGNOSTIC_TEST

Blood biomarker

different stages of individuals with Alzheimer's disease

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Chen Zhang

CONTACT

86+83572462chenzizm@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 27, 2024

Study Start

June 18, 2024

Primary Completion

March 26, 2026

Study Completion

March 26, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations

CN(1)