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

Study Overview
=================
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%. 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.

Official Title
-----------------
Shanghai Mental Health Center

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Diagnostic Test: MicRNAs battery kits


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal aged<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| MCI due to AD<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| Mild AD<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| Moderate AD<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| Severe AD<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| Dementia with Lewy body<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|
| Frontotemporal dementia<br> | Diagnostic Test: MicRNAs battery kits<br>* Novel peripheral blood diagnostic biomarker for MCI due to AD.<br>|

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. | MicRNAs battery for diagnostic of MCI due to AD | 1 and half years |