Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease (Precision1000)

September 21, 2021 updated by: Shanghai Mental Health Center

Shanghai Mental Health Center

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tao Wang, M.D., Ph.D.
  • Phone Number: +862164387250
  • Email: wtshhwy@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NC, AD, DLB, FTD and MCI due to AD

Description

Inclusion Criteria:

  • 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

Exclusion Criteria:

  • Dementia caused by infection or substance
  • Thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal aged
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
MCI due to AD
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
Mild AD
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
Moderate AD
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
Severe AD
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
Dementia with Lewy body
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.
Frontotemporal dementia
Diagnostic test: MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.
Time Frame: 1 and half years
MicRNAs battery for diagnostic of MCI due to AD
1 and half years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WT20200808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

According to the approval of IRB.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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