Mild Cognitive ImpairmentNCT01552265
Shanghai Mild Cognitive Impairment Cohort Study
An observational study of Mild Cognitive Impairment, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in China.
Trial summary
This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to 31 Jul 2017
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects
Who may be able to join
- Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
- Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
- Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
- Objective memory loss* as evidenced by Auditory Verbal Learning test (AVLT-HS)
- Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
- Not-demented, as defined by '"All-cause Dementia" (see 3.4. All-cause Dementia)
- Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
- Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single-group MCI patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Conversion from MCI to "Probable AD Dementia"
Measured: 3 years
Secondary outcomes (5)
Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"
Measured: 3 years
Time to Conversion from MCI to "All-cause Dementia"
Measured: 3 years
Overall survival
Measured: 3 years
Changes in Neuropsychological examinations
Measured: baseline, annual and 3 years
Changes in MRI
Measured: baseline, annual and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2017
- Study completion31 Jul 2017
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 Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Yoji Nagai, MD,PhD, Study director, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552265
- Sponsor's protocol ID
- TRIAD1109
- Status last verified
- Apr 2018
- First submitted
- 15 Feb 2012
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou B, Zhao Q, Kojima S, Ding D, Higashide S, Nagai Y, Guo Q, Kagimura T, Fukushima M, Hong Z. One-year Outcome of Shanghai Mild Cognitive Impairment Cohort Study. Curr Alzheimer Res. 2019;16(2):156-165. doi: 10.2174/1567205016666181128151144.
PubMed 30484408
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01552265
- Acronym / sponsor ID
- TRIAD1109
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Feb 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 13 Mar 2012 (estimated)
- 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.
This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group MCI patients | – | – |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects
Key inclusion criteria (8 listed)
- Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
- Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
- Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
- Objective memory loss* as evidenced by Auditory Verbal Learning test (AVLT-HS)
- Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Conversion from MCI to "Probable AD Dementia"
Time frame: 3 years
5 secondary outcomes
Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"
Time frame: 3 years
Time to Conversion from MCI to "All-cause Dementia"
Time frame: 3 years
Overall survival
Time frame: 3 years
Changes in Neuropsychological examinations
Time frame: baseline, annual and 3 years
Changes in MRI
Time frame: baseline, annual and 3 years
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 25 Apr 2018.
- Derived from this study: PubMed 30484408Zhou B, Zhao Q, Kojima S, Ding D, Higashide S, Nagai Y, Guo Q, Kagimura T, Fukushima M, Hong Z. One-year Outcome of Shanghai Mild Cognitive Impairment Cohort Study. Curr Alzheimer Res. 2019;16(2):156-165. doi: 10.2174/1567205016666181128151144.
- Related InfoLink provided by the sponsor.
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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.
Yoji Nagai, MD,PhD study director
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan
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 Mild Cognitive Impairment, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan 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 8 inclusion and 0 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 25 Apr 2018. 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?
Time to Conversion from MCI to "Probable AD Dementia" (time frame: 3 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 NCT01552265, 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 25 Apr 2018.