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

Withdrawn

• Conditions: Mild Cognitive Impairment
• Interventions: Other: No intervention

• Registration Number: NCT03388242
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-23
• Study First Posted: 2018-01-02
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal control people	No intervention	These people are age-matched with the patients with MCI. No intervention is applied.
Patients with MCI	No intervention	These patients have met the criteria for diagnosing MCI. No intervention is applied.
Patients with AD	No intervention	These patients are diagnosed with AD. No intervention is applied.

Primary Outcome Measures

Name	Time	Method
Fold changes of proteins in the blood of Patients with MCI over control people.	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.	serum and plasma will be used in the screen.
Fold changes of microRNAs in the blood of Patients with MCI over control people.	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.	serum and plasma will be used in the screen.

Trial Locations

Locations (2)

Third Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China