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

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ClinicalTrials.gov Identifier: NCT03388242
Recruitment Status : Unknown
Verified January 2019 by Zhiyi Zuo, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : January 2, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Zhiyi Zuo, 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.

Condition or disease Intervention/treatment
Mild Cognitive Impairment 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Fold changes of microRNAs in the blood of Patients with MCI over control people. [ Time Frame: 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.

  2. Fold changes of proteins in the blood of Patients with MCI over control people. [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People in general clinic or from community.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388242


Contacts
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Contact: Mingyan Guo 020-81332283 guomyan@mail.sysu.edu.cn

Locations
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China, Guangdong
Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Mingyan Guo, MD    020-81332283    guomyan@mail.sysu.edu.cn   
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Mingyan Guo, MD    020-81332283    guomyan@mail.sysu.edu.cn   
Principal Investigator: Mingyan Guo         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhiyi Zuo, MD, Ph.D. Sun Yat-sen University
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Responsible Party: Zhiyi Zuo, Professor and Chair, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03388242    
Other Study ID Numbers: SYSEC-KY-060
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will NOT share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders