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Trial record 2 of 10 for:    microRNAs | Alzheimer Disease

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

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ClinicalTrials.gov Identifier: NCT01819545
Recruitment Status : Unknown
Verified February 2014 by Shanghai Mental Health Center.
Recruitment status was:  Recruiting
First Posted : March 27, 2013
Last Update Posted : February 19, 2014
Sponsor:
Collaborators:
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
Information provided by (Responsible Party):
Shanghai Mental Health Center

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.

Condition or disease
Alzheimer's Disease

Detailed Description:
The Real-Time PCR was the main method in the research.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Shanghai Mental Health Center
Study Start Date : January 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2015


Group/Cohort
Alzheimer's disease
no intervention
Mild cognitive impairment
no intervention
Normal aging
no intervention



Primary Outcome Measures :
  1. plasma and CSF press of miRNA 107 and BACE1 mRNA [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Plasma miRNA107 and BACE1mRNA are to be retained.


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819545


Contacts
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Contact: Tao Wang, M.D., Ph.D. +86-21-34289888 ext 3440 wtshhwy@163.com
Contact: Shifu Xiao, M.D., Ph.D. +86-21-34289888 ext 3441 xiaoshifu@msn.com

Locations
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China, Shanghai
Department of Psychogeriatrics,Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Tao Wang, M.D., Ph.D.    +86-21-34289888 ext 3440    wtshhwy@163.com   
Sub-Investigator: Shuhui Dong, M.D.         
Sub-Investigator: Cece Yang, M.D.         
Sub-Investigator: Yan Cheng, M.D.         
Sponsors and Collaborators
Shanghai Mental Health Center
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
Investigators
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Principal Investigator: Tao Wang, M.D., PhD. Department of Psychogeriatrics,Shanghai Mental Health Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01819545    
Other Study ID Numbers: 10ZR1425800
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Shanghai Mental Health Center:
Alzheimer's disease
diagnosis
MicRNA
mRNA
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders