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

NCT03388242 | Withdrawn

• 1 other identifier: SYSEC-KY-060
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Normal control people

These people are age-matched with the patients with MCI. No intervention is applied.

Other: No intervention

Patients with MCI

These patients have met the criteria for diagnosing MCI. No intervention is applied.

Other: No intervention

Patients with AD

These patients are diagnosed with AD. No intervention is applied.

Other: No intervention

Interventions

No intervention OTHER

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.

Normal control people; Patients with AD; Patients with MCI

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People in general clinic or from community.

You may qualify if:

• Age-matched with patients with MCI group

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhiyi Zuo, MD, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 2, 2018
• Study Start: December 7, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)