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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

Tracking Information
First Submitted Date March 24, 2013
First Posted Date March 27, 2013
Last Update Posted Date February 19, 2014
Study Start Date January 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2013)
plasma and CSF press of miRNA 107 and BACE1 mRNA [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title 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.
Detailed Description The Real-Time PCR was the main method in the research.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma miRNA107 and BACE1mRNA are to be retained.
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.
Condition Alzheimer's Disease
Intervention Not Provided
Study Groups/Cohorts
  • Alzheimer's disease
    no intervention
  • Mild cognitive impairment
    no intervention
  • Normal aging
    no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 24, 2013)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01819545
Other Study ID Numbers 10ZR1425800
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shanghai Mental Health Center
Study Sponsor Shanghai Mental Health Center
Collaborators
  • Shanghai Municipal Science and Technology Commission
  • National Natural Science Foundation of China
Investigators
Principal Investigator: Tao Wang, M.D., PhD. Department of Psychogeriatrics,Shanghai Mental Health Center
PRS Account Shanghai Mental Health Center
Verification Date February 2014