Protein and microRNA Markers for Early Detection of Alzheimer's Disease

Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease

Blood will be harvested from three groups of people, normal control, patients with mild cognitive impairment (MCI) and patients with Alzheimer's disease (AD), 20 people per group. The blood samples will be used to determine the difference in the expression of microRNAs and proteins. Blood samples will be harvested again at 6-month interval from patients. The combination of the microRNAs and proteins that have different expression patterns between normal control and patients with MCI will be constructed in a kit to detect the difference. This kit will be used in another set of the three groups of people to determine its sensitivity and specificity in detecting patients with MCI.

Study Overview

• Status: Withdrawn
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: No intervention

Detailed Description

As discussed above, patients' blood samples will be tested by chip to test microRNA expression and liquid chromatography-mass spectrometry to determine protein expression. The differences in microRNA and protein expression among the three groups, especially between the control and MCI, will be analyzed. This information will be used to construct a kit that can contain probes to detect a few microRNAs or proteins. This kit will be used in another set of patients to check its sensitivity and specificity. The first set of patients will also be followed up every 6 months for up to 1.5 years. Blood samples will be harvested during the follow-ups. The changes in microRNAs and proteins will be correlated with the changes of cognition. This information will be used for constructing the kit as well.

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Mingyan Guo; Phone Number: 020-81332283; Email: guomyan@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital
    • Guangzhou, Guangdong, China, 510000
      • Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People in general clinic or from community.

Description

Inclusion Criteria:

• Age-matched with patients with MCI group

Exclusion Criteria:

• With cognitive dysfunction
• With major cardiovascular diseases, especially stroke and brain transient ischemic attack
• On steroid treatment
• with major organ diseases

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal control people; These people are age-matched with the patients with MCI. No intervention is applied.	Other: No intervention; Patients will be recruited into the study in their initial visit before patients are on any drug treatments for their AD or MCI. The study does not include use of any interventions.
Patients with MCI; These patients have met the criteria for diagnosing MCI. No intervention is applied.	Other: No intervention; Patients will be recruited into the study in their initial visit before patients are on any drug treatments for their AD or MCI. The study does not include use of any interventions.
Patients with AD; These patients are diagnosed with AD. No intervention is applied.	Other: No intervention; Patients will be recruited into the study in their initial visit before patients are on any drug treatments for their AD or MCI. The study does not include use of any interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fold changes of microRNAs in the blood of Patients with MCI over control people.	serum and plasma will be used in the screen.	Patients with MCI and AD will be evaluated every 6 month for 1.5 years to monitor the changes in their cognition and the expression patterns of microRNAs and proteins.
Fold changes of proteins in the blood of Patients with MCI over control people.	serum and plasma will be used in the screen.	Patients with MCI and AD will be evaluated every 6 month for 1.5 years to monitor the changes in their cognition and the expression patterns of microRNAs and proteins.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Zhiyi Zuo, MD, Ph.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Estimated): March 30, 2020
• Study Completion (Estimated): March 30, 2020

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 23, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: SYSEC-KY-060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will NOT share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No