The Study of microRNA 107 (miRNA 107) and Beta-amyloid Precursor Protein-cleaving Enzyme 1 (BACE1) Messenger Ribonucleic Acid (mRNA) Gene Expression in Cerebrospinal Fluid and Peripheral Blood of Alzheimer's Disease
Shanghai Mental Health Center
1 other identifier
observational
300
1 country
1
Brief Summary
The miRNA 107 gene is increasingly appreciated to serve key functions in humans. The miRNA regulate gene expression involved in cell division, metabolism, stress response, and angiogenesis in vertebrate species. But the relationship and diagnosis capability of miRNA 107 and BACE1 mRNA gene expression in plasma and cerebrospinal fluid (CSF) of amnestic mild cognitive impairment (aMCI) and normal control is still a mystery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 24, 2013
CompletedFirst Posted
Study publicly available on registry
March 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 19, 2014
February 1, 2014
2.5 years
March 24, 2013
February 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma and CSF press of miRNA 107 and BACE1 mRNA
24 months
Study Arms (3)
Alzheimer's disease
no intervention
Mild cognitive impairment
no intervention
Normal aging
no intervention
Eligibility Criteria
the subjects were collected from Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine (Alzheimer's Disease and Related Disorders Center, ADRDC) and the of Shanghai Changning district, Huangpu district and Putuo district.
You may qualify if:
- Probable Alzheimer's disease (AD) was diagnosed according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria and the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorder's Association (NINCDS/ADRDA) criteria.
- AMCI was diagnosed based on the following criteria (Petersen et al., 2001): 1) memory complaint, preferably corroborated by a spouse or relative, 2) objective memory impairment, 3) normal general cognitive function, 4) intact activities of daily living, and 5) absence of dementia. We have amended the aMCI diagnostic criteria of the Petersen Mini-Mental State Examination (MMSE) cut-off score in order to be consistent with the low level of education in elderly Chinese people. Research (mingyuan Zhang et al, 1988) found that with the Chinese version of MMSE, AD subjects who had not been educated (NO ED) exhibited MMSE scores of \<18, those with elementary school education exhibited MMSE scores of \<21, and those with higher than middle school education exhibited MMSE scores of \<25. In the present study, the aMCI analysis was carried out on NO ED subjects with MMSE cut-off scores of over 18, elementary school educated subjects with MMSE cut-off scores of over 21, and higher than middle school educated subject with MMSE cut-off scores of over 25.
- The cognitively-normal elderly formed the normal control (NC) group, was independently-functioning community dwellers with no neurological or psychiatric conditions.
You may not qualify if:
- All participants underwent a screening process that included a review of their medical history, physical and neurological examinations, laboratory tests, and MRI analysis. The clinical assessment of mild cognitive impairment or dementia included neuropsychological tests, as well as behavioral and psychiatric interviews conducted by the attending psychiatrist. AD patients recorded scores of \< 4 on the Hachinski Ischemia Scale and showed no history of significant systemic or psychiatric conditions, or traumatic brain injuries that could compromise brain function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychogeriatrics，Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Related Publications (2)
Wang T, Shi F, Jin Y, Jiang W, Shen D, Xiao S. Abnormal Changes of Brain Cortical Anatomy and the Association with Plasma MicroRNA107 Level in Amnestic Mild Cognitive Impairment. Front Aging Neurosci. 2016 May 18;8:112. doi: 10.3389/fnagi.2016.00112. eCollection 2016.
PMID: 27242521DERIVEDWang T, Chen K, Li H, Dong S, Su N, Liu Y, Cheng Y, Dai J, Yang C, Xiao S. The feasibility of utilizing plasma MiRNA107 and BACE1 messenger RNA gene expression for clinical diagnosis of amnestic mild cognitive impairment. J Clin Psychiatry. 2015 Feb;76(2):135-41. doi: 10.4088/JCP.13m08812.
PMID: 25742200DERIVED
Biospecimen
Plasma miRNA107 and BACE1mRNA are to be retained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tao Wang, M.D., PhD.
Department of Psychogeriatrics，Shanghai Mental Health Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2013
First Posted
March 27, 2013
Study Start
January 1, 2012
Primary Completion
July 1, 2014
Study Completion
December 1, 2015
Last Updated
February 19, 2014
Record last verified: 2014-02