Multimodal Ophthalmic Imaging and Plasma Biomarkers for t... | NCT06924359

Studies
Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease

NCT06924359

Sponsor

Peking University First Hospital

Status

Recruiting

Last Update Posted

Apr 11, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Alzheimer's Disease (AD)

Interventions

Multimodal Ophthalmic Imaging and plasma 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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2025Actual

Primary Completion Date

Aug 31, 2027Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Apr 6, 2025

First Submission Date that Met QC Criteria

Apr 6, 2025

First Posted Date

Apr 11, 2025Actual

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

Apr 6, 2025

Last Update Posted Date

Apr 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With the accelerating global aging population, dementia has become a pressing worldwide issue. This project aims to identify specific plasma biomarkers and ocular indicators for the early detection of Alzheimer's disease (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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Different stages of Alzheimer's disease			Diagnostic Test: Multimodal Ophthalmic Imaging and plasma biomarker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multimodal Ophthalmic Imaging and plasma biomarker	Diagnostic Test	Multimodal Ophthalmic Imaging and plasma biomarkers (Aβ42/40, p-tau181, p-tau217, NfL and GFAP）.	Different stages of Alzheimer's disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in Multimodal Ophthalmic Imaging parameter values among groups		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Concentration difference of plasma biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） among groups		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants aged ≥ 50 years;
Participants diagnosed with Alzheimer's Disease (AD), mild cognitive decline (MCI), subjective cognitive decline (SCD), or cognitively normal (CN);
Signed informed consent form

Exclusion Criteria:

Presence of other neurological disorders and systemic diseases that may cause cognitive impairment;
Inability to cooperate with cognitive assessments;
Refusal to undergo blood sampling.

Accepts Healthy Volunteers

Not provided

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

AD, MCI, SCD and CN

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided