Clinical trial NCT03388242: Protein and microRNA Markers for Early Detection of Alzheimer's Disease
Official title: Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mild Cognitive Impairment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in general clinic or from community.

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.

Eligibility 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

Primary outcomes:
measure: Fold changes of microRNAs in the blood of Patients with MCI over control people.
timeFrame: 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.
measure: Fold changes of proteins in the blood of Patients with MCI over control people.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhiyi Zuo, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: