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

NCT ID: NCT04509271

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal aged

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

MCI due to AD

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Mild AD

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Moderate AD

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Severe AD

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Dementia with Lewy body

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Frontotemporal dementia

MicRNAs battery kits

Intervention Type DIAGNOSTIC_TEST

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Interventions

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MicRNAs battery kits

Novel peripheral blood diagnostic biomarker for MCI due to AD.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Wang, M.D., Ph.D.

Role: CONTACT

+862164387250

Facility Contacts

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Tao Wang, Ph.D.

Role: primary

References

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Ma YM, Zhao L. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases. Behav Neurol. 2023 Nov 23;2023:8537296. doi: 10.1155/2023/8537296. eCollection 2023.

Reference Type DERIVED
PMID: 38058356 (View on PubMed)

Other Identifiers

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WT20200808

Identifier Type: -

Identifier Source: org_study_id

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