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Status unknownNCT01819545Updated Feb 19, 2014

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

An observational study in Alzheimer's Disease, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Shanghai Mental Health Center · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
60 Years to 90 Years
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
  • diagnosis
  • MicRNA
  • mRNA
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Alzheimer's disease

    no intervention

  • Mild cognitive impairment

    no intervention

  • Normal aging

    no intervention

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What researchers measure

Primary outcomes

  1. plasma and CSF press of miRNA 107 and BACE1 mRNA

    Time frame: 24 months

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Study locations

1 of 1 sites recruiting
  • Department of Psychogeriatrics,Shanghai Mental Health Center
    Shanghai, Shanghai 200030, China
    • Tao Wang, M.D., Ph.D. · Contact · wtshhwy@163.com · +86-21-34289888
    • Shuhui Dong, M.D. · Sub investigator
    • Cece Yang, M.D. · Sub investigator
    • Yan Cheng, M.D. · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 27242521 ↗
  • Wang 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. PubMed 25742200 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01819545
Lead sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Municipal Science and Technology Commission, National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Jan 2012
Primary completion
Jul 2014 (estimated)
Completion
Dec 2015 (estimated)
Last update
Feb 19, 2014

Study contacts

Tao Wang, M.D., Ph.D.
Contact
wtshhwy@163.com
+86-21-34289888 ext. 3440
Shifu Xiao, M.D., Ph.D.
Contact
xiaoshifu@msn.com
+86-21-34289888 ext. 3441
Tao Wang, M.D., PhD.
principal investigator · Department of Psychogeriatrics,Shanghai Mental Health Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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