A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

NCT04137926 | Unknown DMC

• 1 other identifier: CRC2019ZD03
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• the diagnostic accuracy of biomarkers for MCI due to AD

  MicRNAs battery for diagnostic of MCI due to AD

  2 years

• Neropsychological test battery

  MicRNAs for intervene of MCI due to AD

  2 years

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  2 years

Study Arms (3)

Alzheimer's disease

EXPERIMENTAL

Diagnostic Test: MicRNAs battery

MCI due to AD

EXPERIMENTAL

Diagnostic Test: MicRNAs battery

Normal Elderly

EXPERIMENTAL

Diagnostic Test: MicRNAs battery

Interventions

MicRNAs battery DIAGNOSTIC_TEST

for MCI due to AD diagnosis

Alzheimer's disease; MCI due to AD; Normal Elderly

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NIA-AA criteria of MCI due to AD or AD

You may not qualify if:

• Non AD dementia

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Department of Psychogeriatrics，Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yifeng Shen, M.D.

CONTACT

00862164387250; shenyifeng@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: AD, MCI due to AD and Normal Control

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: March 1, 2020
• Primary Completion: August 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 23, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)