Mild Cognitive ImpairmentNCT03388242
Protein and microRNA Markers for Early Detection of Alzheimer's Disease
An observational study of Mild Cognitive Impairment, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- 7 Dec 2017to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People in general clinic or from community.
Who may be able to join
- Age-matched with patients with MCI group
Who cannot join
- With cognitive dysfunction
- With major cardiovascular diseases, especially stroke and brain transient ischemic attack
- On steroid treatment
- with major organ diseases
Trial locations and contacts
2 sites in 1 country.
China2 sites
Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
About this study
Official title: Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- No intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal control people | These people are age-matched with the patients with MCI. No intervention is applied. Receives: Other: No intervention | |
| Patients with MCI | These patients have met the criteria for diagnosing MCI. No intervention is applied. Receives: Other: No intervention | |
| Patients with AD | These patients are diagnosed with AD. No intervention is applied. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold changes of microRNAs in the blood of Patients with MCI over control people.
serum and plasma will be used in the screen.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start7 Dec 2017
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Why it stopped: The research group is too busy to do this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Zuo, Sun Yat-sen University
- Investigators
- Zhiyi Zuo, MD, Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388242
- Sponsor's protocol ID
- SYSEC-KY-060
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2017
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will NOT share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03388242
- Acronym / sponsor ID
- SYSEC-KY-060
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The research group is too busy to do this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control people | – | Other: No interventionThese people are age-matched with the patients with MCI. No intervention is applied. |
| Patients with MCI | – | Other: No interventionThese patients have met the criteria for diagnosing MCI. No intervention is applied. |
| Patients with AD | – | Other: No interventionThese patients are diagnosed with AD. No intervention is applied. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People in general clinic or from community.
Key inclusion criteria (1 listed)
- Age-matched with patients with MCI group
Key exclusion criteria (4 listed)
- With cognitive dysfunction
- With major cardiovascular diseases, especially stroke and brain transient ischemic attack
- On steroid treatment
- with major organ diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients 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. | Other | Normal control people, Patients with AD, Patients with MCI |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No. We will NOT share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyi Zuo, MD, Ph.D. principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.