Mild Cognitive ImpairmentNCT03672448
The China Longitudinal Aging Study of Cognitive Impairment
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Dementia, Vascular
- What is being tested?
- Naturalistic observation
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10,000 adult Chinese aged 60 and up who have been living Shanghai will be recruited.
Who may be able to join
- registered residents in the community;
- ≥ 60 years;
- without schizophrenia or mental retardation;
- be able to communicate and accept physical and cognitive examinations
Who cannot join
- blind
- deaf mute
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Centre
Shanghai, Shanghai Municipality, 200030
Shifu Xiao, M.D., Ph.D.
Tao Wang, M.D., Ph.D.
About this study
Official title: Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine
Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. Based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank. The study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study. In addition, The study will make an effective supplement the sample bank construction of Shanghai Mental Health Center.
Read the detailed description
The neuropsychological test battery are used to access the cognitive function of subjects in the study. The brain MRI and biochemical examination will be done in the screening period. The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Frontal, Depression
- Being tested
- Naturalistic observation
- Keywords
- dementia, depression, cohort study, sample bank, precision diagnosis, brain imaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Depression, Anxiety Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic observationOther
Also called Normal Aging
Naturalistic observation
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive disorder | Dementias Receives: Other: Naturalistic observation | |
| Normal Aging | Normal Aging with normal cognitive function Receives: Other: Naturalistic observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, incidence of neurocognitive disorder
Prevalence, incidence of neurocognitive disorder such as AD, MCI and other types of dementia
Measured: 5 years
Secondary outcomes (2)
Prevalence, incidence of mood disorder
Prevalence, incidence of mood disorder such as depression, anxiaty
Measured: 5 years
conversion rate
conversion rate of neurocognitive disorder from Normal Elderly
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 posted14 Sep 2018
- Study start1 Sep 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (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 Mild Cognitive ImpairmentStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huafang Li, M.D., Ph.D., Principal investigator, Shanghai Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672448
- Sponsor's protocol ID
- CRC2017ZD02
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2018
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang T, He H, Shi Y, Su N, Zhu M, Yan F, Liu Y, Li J, Tang M, Chen W, Bao F, Wang H, Wang Y, Liu Y, Yuan Y, Zuo X, Zhang X, Cui L, Wu W, Zhang C, Lu Y, Fang Y, Xiao S. Prevalence, incidence and modifiable factors for subtypes of mild cognitive impairment: results from the Longitudinal Ageing Study in China. Gen Psychiatr. 2025 Mar 7;38(2):e101736. doi: 10.1136/gpsych-2024-101736. eCollection 2025.
PubMed 40070969
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine
- ClinicalTrials.gov ID
- NCT03672448
- Acronym / sponsor ID
- CRC2017ZD02
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Frontal, Depression
- Keywords
- dementia, depression, cohort study, sample bank, precision diagnosis, brain imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 14 Sep 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.
Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. Based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank. The study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study. In addition, The study will make an effective supplement the sample bank construction of Shanghai Mental Health Center.
Detailed description
The neuropsychological test battery are used to access the cognitive function of subjects in the study. The brain MRI and biochemical examination will be done in the screening period. The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive disorder | – | Other: Naturalistic observationDementias |
| Normal Aging | – | Other: Naturalistic observationNormal Aging with normal cognitive function |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10,000 adult Chinese aged 60 and up who have been living Shanghai will be recruited.
Key inclusion criteria (4 listed)
- registered residents in the community;
- ≥ 60 years;
- without schizophrenia or mental retardation;
- be able to communicate and accept physical and cognitive examinations
Key exclusion criteria (2 listed)
- blind
- deaf mute
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 |
|---|---|---|
| Naturalistic observationAlso: Normal AgingNaturalistic observation | Other | Neurocognitive disorder, Normal Aging |
Primary outcome
Prevalence, incidence of neurocognitive disorder
Time frame: 5 years
Prevalence, incidence of neurocognitive disorder such as AD, MCI and other types of dementia
2 secondary outcomes
Prevalence, incidence of mood disorder
Time frame: 5 years
conversion rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 40070969Wang T, He H, Shi Y, Su N, Zhu M, Yan F, Liu Y, Li J, Tang M, Chen W, Bao F, Wang H, Wang Y, Liu Y, Yuan Y, Zuo X, Zhang X, Cui L, Wu W, Zhang C, Lu Y, Fang Y, Xiao S. Prevalence, incidence and modifiable factors for subtypes of mild cognitive impairment: results from the Longitudinal Ageing Study in China. Gen Psychiatr. 2025 Mar 7;38(2):e101736. doi: 10.1136/gpsych-2024-101736. eCollection 2025.
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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.
Huafang Li, M.D., Ph.D. principal investigator
Shanghai Mental Health Centre
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 and 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 4 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 10 Jan 2020. 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 Shifu Xiao, M.D., Ph.D. (00862164387250 ext. 73441, xiaoshifu@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, incidence of neurocognitive disorder (time frame: 5 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 NCT03672448, 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 10 Jan 2020.