Back to resultsA Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MicRNAs battery
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- 2011 NIA-AA criteria of MCI due to AD or AD
Exclusion Criteria:
- Non AD dementia
Sites / Locations
- Department of Psychogeriatrics，Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Alzheimer's disease
MCI due to AD
Normal Elderly
Arm Description
Outcomes
Primary Outcome Measures
the diagnostic accuracy of biomarkers for MCI due to AD
MicRNAs battery for diagnostic of MCI due to AD
Neropsychological test battery
MicRNAs for intervene of MCI due to AD
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by MicRNAs.
Full Information
NCT ID
NCT04137926
First Posted
October 21, 2019
Last Updated
September 21, 2021
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04137926
Brief Title
A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease
Official Title
Shanghai Mental Health Center
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AD, MCI due to AD and Normal Control
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Title
MCI due to AD
Arm Type
Experimental
Arm Title
Normal Elderly
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MicRNAs battery
Intervention Description
for MCI due to AD diagnosis
Primary Outcome Measure Information:
Title
the diagnostic accuracy of biomarkers for MCI due to AD
Description
MicRNAs battery for diagnostic of MCI due to AD
Time Frame
2 years
Title
Neropsychological test battery
Description
MicRNAs for intervene of MCI due to AD
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of participants with treatment-related adverse events as assessed by MicRNAs.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
2011 NIA-AA criteria of MCI due to AD or AD
Exclusion Criteria:
Non AD dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yifeng Shen, M.D.
Phone
00862164387250
Email
shenyifeng@yahoo.com
Facility Information:
Facility Name
Department of Psychogeriatrics，Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wang, M.D., Ph.D.
Phone
+86-21-34289888
Ext
3440
Email
wtshhwy@163.com
First Name & Middle Initial & Last Name & Degree
Qun Xu, M.D.
First Name & Middle Initial & Last Name & Degree
Gang Li, M.D.
First Name & Middle Initial & Last Name & Degree
Chenpeng Zhang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After the study is finished.
Learn more about this trial
A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease
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