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

Study Overview
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal control people<br>These people are age-matched with the patients with MCI. No intervention is applied. | Other: No intervention<br>* 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.<br>|
| Patients with MCI<br>These patients have met the criteria for diagnosing MCI. No intervention is applied. | Other: No intervention<br>* 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.<br>|
| Patients with AD<br>These patients are diagnosed with AD. No intervention is applied. | Other: No intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |