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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03388242
• Other study ID #: SYSEC-KY-060
• Status: Withdrawn
• Start date: December 7, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong
China	Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.