Alzheimer's Disease Clinical Trial
Official title:
Shanghai Mental Health Center
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.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | November 30, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - 2011 NIA-AA criteria of MCI due to AD or AD Exclusion Criteria: - Non AD dementia |
Country | Name | City | State |
---|---|---|---|
China | Department of Psychogeriatrics,Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the diagnostic accuracy of biomarkers for MCI due to AD | MicRNAs battery for diagnostic of MCI due to AD | 2 years | |
Primary | Neropsychological test battery | MicRNAs for intervene of MCI due to AD | 2 years | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by MicRNAs. | 2 years |
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