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

NCT ID: NCT03388242

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-07

Study Completion Date

2020-03-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal control people

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

No intervention

Intervention Type 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.

Patients with MCI

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

No intervention

Intervention Type 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.

Patients with AD

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

No intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhiyi Zuo

Visiting Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiyi Zuo, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSEC-KY-060

Identifier Type: -

Identifier Source: org_study_id

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