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

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04137926

Collaborator

(none)

360

Enrollment

Location

Arms

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Diagnostic Test: MicRNAs battery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

AD, MCI due to AD and Normal ControlAD, MCI due to AD and Normal Control

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

In this study, the clinical researchers are responsible for the clinical diagnosis of the subjects and the diagnosis of senile plaques. The biological sample testing agency receives the blind coded samples. After the repeated testing, the data are handed over to the blind statistical experts for statistics. The statistical experts only obtain the grouping information and biological sample data, but do not know the specific diagnosis grouping, so as to ensure the accuracy of the statistical results. The results were analyzed by the researchers after the completion of the statistics.

Primary Purpose:

Diagnostic

Official Title:

Shanghai Mental Health Center

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the diagnostic accuracy of biomarkers for MCI due to AD [2 years]
MicRNAs battery for diagnostic of MCI due to AD
Neropsychological test battery [2 years]
MicRNAs for intervene of MCI due to AD

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [2 years]
Number of participants with treatment-related adverse events as assessed by MicRNAs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Non AD dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychogeriatrics，Shanghai Mental Health Center	Shanghai	Shanghai	China	200030

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Mental Health Center

ClinicalTrials.gov Identifier:

NCT04137926

Other Study ID Numbers:

CRC2019ZD03

First Posted:

Oct 24, 2019

Last Update Posted:

Sep 23, 2021

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Sep 23, 2021