A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

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%. 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. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. 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. [18F]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Department of Psychogeriatrics，Shanghai Mental Health Center
        • Contact:
          • Tao Wang, M.D., Ph.D.
          • Phone Number: 3440 +86-21-34289888
          • Email: wtshhwy@163.com
        • Sub-Investigator:
          • Qun Xu, M.D.
        • Sub-Investigator:
          • Gang Li, M.D.
        • Sub-Investigator:
          • Chenpeng Zhang, M.D.

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2011 NIA-AA criteria of MCI due to AD or AD

Exclusion Criteria:

  • Non AD dementia

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer's disease
Diagnostic test: MicRNAs battery
for MCI due to AD diagnosis
Experimental: MCI due to AD
Diagnostic test: MicRNAs battery
for MCI due to AD diagnosis
Experimental: Normal Elderly
Diagnostic test: MicRNAs battery
for MCI due to AD diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the diagnostic accuracy of biomarkers for MCI due to AD
Time Frame: 2 years
MicRNAs battery for diagnostic of MCI due to AD
2 years
Neropsychological test battery
Time Frame: 2 years
MicRNAs for intervene of MCI due to AD
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 2 years
Number of participants with treatment-related adverse events as assessed by MicRNAs.
2 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)

March 1, 2020

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (Actual)

October 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC2019ZD03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After the study is finished.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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