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Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease

Shanghai Mental Health Center

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04509271
Acronym
Precision1000
Enrollment
1300
Registered
2020-08-12
Start date
2020-10-01
Completion date
2022-09-30
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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%. Peripheral Blood biomarkers 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. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. 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. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.

Interventions

DIAGNOSTIC_TESTMicRNAs battery kits

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

Exclusion criteria

* Dementia caused by infection or substance * Thyroid disease

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.1 and half yearsMicRNAs battery for diagnostic of MCI due to AD

Countries

China

Contacts

Primary ContactTao Wang, M.D., Ph.D.
wtshhwy@163.com+862164387250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026