Alzheimer's Disease
Conditions
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%. 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. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. 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. \[18F\]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.
Interventions
DIAGNOSTIC_TESTMicRNAs battery
for MCI due to AD diagnosis
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
In this study, the clinical researchers are responsible for the clinical diagnosis of the subjects and the diagnosis of senile plaques. The biological sample testing agency receives the blind coded samples. After the repeated testing, the data are handed over to the blind statistical experts for statistics. The statistical experts only obtain the grouping information and biological sample data, but do not know the specific diagnosis grouping, so as to ensure the accuracy of the statistical results. The results were analyzed by the researchers after the completion of the statistics.
Intervention model description
AD, MCI due to AD and Normal Control
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 2011 NIA-AA criteria of MCI due to AD or AD
Exclusion criteria
* Non AD dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the diagnostic accuracy of biomarkers for MCI due to AD | 2 years | MicRNAs battery for diagnostic of MCI due to AD |
| Neropsychological test battery | 2 years | MicRNAs for intervene of MCI due to AD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 2 years | Number of participants with treatment-related adverse events as assessed by MicRNAs. |
Countries
China
Contacts
Primary ContactYifeng Shen, M.D.
Outcome results
None listed