Alzheimer DiseasePrecision1000NCT04509271
Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease
An observational study of Alzheimer Disease, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MicRNAs battery kits
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NC, AD, DLB, FTD and MCI due to AD
Who may be able to join
- 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)
Who cannot join
- Dementia caused by infection or substance
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Tao Wang, Ph.D., wtshhwy@163.com
About this study
Official title: Shanghai Mental Health Center
The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.
- Conditions
- Alzheimer Disease
- Being tested
- MicRNAs battery kits
- 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 battery kitsDiagnostic test
Novel peripheral blood diagnostic biomarker for MCI due to AD.
| Study group | Role | What they receive |
|---|---|---|
| Normal aged | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| MCI due to AD | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| Mild AD | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| Moderate AD | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| Severe AD | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| Dementia with Lewy body | Not described Receives: Diagnostic Test: MicRNAs battery kits | |
| Frontotemporal dementia | Not described Receives: Diagnostic Test: MicRNAs battery kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.
MicRNAs battery for diagnostic of MCI due to AD
Measured: 1 and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,300 participants (estimated)
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
- NCT04509271
- Sponsor's protocol ID
- WT20200808
- Acronym
- Precision1000
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to the approval of IRB.
Publications
Ma YM, Zhao L. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases. Behav Neurol. 2023 Nov 23;2023:8537296. doi: 10.1155/2023/8537296. eCollection 2023.
PubMed 38058356
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Mental Health Center
- ClinicalTrials.gov ID
- NCT04509271
- Acronym / sponsor ID
- Precision1000 / WT20200808
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 12 Aug 2020 (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.
The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Normal aged | – | Diagnostic Test: MicRNAs battery kits |
| MCI due to AD | – | Diagnostic Test: MicRNAs battery kits |
| Mild AD | – | Diagnostic Test: MicRNAs battery kits |
| Moderate AD | – | Diagnostic Test: MicRNAs battery kits |
| Severe AD | – | Diagnostic Test: MicRNAs battery kits |
| Dementia with Lewy body | – | Diagnostic Test: MicRNAs battery kits |
| Frontotemporal dementia | – | Diagnostic Test: MicRNAs battery kits |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NC, AD, DLB, FTD and MCI due to AD
Key inclusion criteria (1 listed)
- 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)
Key exclusion criteria (2 listed)
- Dementia caused by infection or substance
- Thyroid disease
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 battery kitsNovel peripheral blood diagnostic biomarker for MCI due to AD. | Diagnostic test | Dementia with Lewy body, Frontotemporal dementia, MCI due to AD, Mild AD, Moderate AD, Normal aged, Severe AD |
Primary outcome
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.
Time frame: 1 and half years
MicRNAs battery for diagnostic of MCI due to AD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 38058356Ma YM, Zhao L. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases. Behav Neurol. 2023 Nov 23;2023:8537296. doi: 10.1155/2023/8537296. eCollection 2023.
- Individual participant dataSharing planned: Undecided. According to the approval of IRB.
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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.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, M.D., Ph.D. (+862164387250, wtshhwy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia. (time frame: 1 and half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509271, which also lists 1 linked publication.
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 27 Sep 2021.