Blood Biomarkers for Screening of Alzheimer's Disease | NCT06477484

Studies
Blood Biomarkers for Screening of Alzheimer's Disease

NCT06477484

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Jun 27, 2024Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Alzheimer's Disease
Blood Biomarkers

Interventions

Blood biomarker

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2024Actual

Primary Completion Date

Mar 26, 2026Estimated

Completion Date

Mar 26, 2026Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jun 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2024

Last Update Posted Date

Jun 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
different stages of individuals with Alzheimer's disease			Diagnostic Test: Blood biomarker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood biomarker	Diagnostic Test	Blood biomarker	different stages of individuals with Alzheimer's disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the diagnostic accuracy of blood biomarkers of Aβ42, Aβ40, Aβ42/Aβ40, P-Tau181, P-Tau217, GFAP and NfL.		2 years

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the diagnostic accuracy of a comprehensive model combined with core blood biomarkers and clinical information.		2 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen Zhang	Contact	86+83572462		chenzizm@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital	Recruiting	Beijing	Beijing Municipality	100034	China

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided