Alzheimer DiseaseMicroRNAs ADNCT05055310
The Mechanism of MicroRNAs Network in Alzheimer's Disease
An observational study of Alzheimer Disease, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MicRNAs test
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 31 Dec 2019
- How long will I take part?
- 5 Years
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: age between 60 to 90 years old.
Who may be able to join
- NIA-AA MCI due to AD clinical criteria for MCI due to AD
- NIA-AA AD clinical criteria for AD
Who cannot join
- Other type of dementia
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychogeriatrics，Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Shanghai Mental Health Center
MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD.
- Conditions
- Alzheimer Disease
- Being tested
- MicRNAs test
- Keywords
- MicroRNAs, Alzheimer's Disease, Validation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicRNAs testDiagnostic test
plasma micRNAs concentration
| Study group | Role | What they receive |
|---|---|---|
| Normal elderly | normal cognitive group Receives: Diagnostic Test: MicRNAs test | |
| aMCI | amnestic mild cognitive impairment Receives: Diagnostic Test: MicRNAs test | |
| AD | Alzhiemer's disease Receives: Diagnostic Test: MicRNAs test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicRNAs diagnosis validation for aMCI
MicRNAs concentration in plasma among three groups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startOct 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- 1,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055310
- Sponsor's protocol ID
- 81571298
- Acronym
- MicroRNAs AD
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Mental Health Center
- ClinicalTrials.gov ID
- NCT05055310
- Acronym / sponsor ID
- MicroRNAs AD / 81571298
- Conditions
- Alzheimer Disease
- Keywords
- MicroRNAs, Alzheimer's Disease, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Sep 2021 (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.
MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal elderly | – | Diagnostic Test: MicRNAs testnormal cognitive group |
| aMCI | – | Diagnostic Test: MicRNAs testamnestic mild cognitive impairment |
| AD | – | Diagnostic Test: MicRNAs testAlzhiemer's disease |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- age between 60 to 90 years old.
Key inclusion criteria (2 listed)
- NIA-AA MCI due to AD clinical criteria for MCI due to AD
- NIA-AA AD clinical criteria for AD
Key exclusion criteria (1 listed)
- Other type of dementia
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 |
|---|---|---|
| MicRNAs testplasma micRNAs concentration | Diagnostic test | AD, Normal elderly, aMCI |
Primary outcome
MicRNAs diagnosis validation for aMCI
Time frame: 5 years
MicRNAs concentration in plasma among three groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Shanghai Mental Health Center at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MicRNAs diagnosis validation for aMCI (time frame: 5 years). 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 24 Sep 2021.