MCINCT04360200
Cognitive Impairment in Ageing People
An observational study of MCI and Alzheimer Disease, run by Yamei Tang at 1 site in China.
Trial summary
Mild cognitive impairment (MCI) and neurocognitive disorder such as 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- MCI, Alzheimer Disease, VAD - Vascular Dementia
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Chinese aged 50 and up, receiving outpatient or inpatient service of Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Who may be able to join
- Patients over 50 years old.
- Sign informed consent.
- According to DSM-IV, the diagnostic standard of dementia was not met.
- The clinical dementia rating (CDR) was 0.5.
Who cannot join
- Subjects with mental retardation.
- Refuse to have blood sampling, imaging and other examinations.
- Uncooperative subjects that have serious organic diseases, or have a history of mental illness, or have physical disability (including severe aphasia).
- Contraindications of MR scanning.
- Suffering from serious physical or mental illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yamet Tang, M. D., Ph. D, 86-020-34070569, yameitang@hotmail.com
Yamei Tang, M. D., Ph. D
About this study
Official title: Cognitive Impairment in Ageing People: A Longitudinal Observational Prospective Study
Mild cognitive impairment (MCI) and neurocognitive disorder such as 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. The study will construct a prospective cohort to establish database that provide not only comprehensive epidemiological data on the MCI and neurocognitive disorder in ageing people, but also complete the construction of biological samples bank and clinical diagnosis and treatment information database. Using the database, the study will identify the conversion rates from MCI to dementia and risk factors for the progression from MCI to dementia or AD. The study will also apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study have goals to identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of cognitive disorders.
- Conditions
- MCI, Alzheimer Disease, VAD - Vascular Dementia, Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
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 |
|---|---|---|
| Normal Aging | Normal Aging with normal cognitive function | |
| Mild cognitive impairment (MCI) | Mild cognitive impairment subjects with memory loss as predominant symptom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dementia
Measured: April 2020 to December 2040
Secondary outcomes (2)
The conversion rate of normal elderly to MCI to neurocognitive disorder
Measured: April 2020 to December 2040
Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score
Measured: April 2020 to December 2040
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Apr 2020
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (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 MCIStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yamei Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360200
- Sponsor's protocol ID
- 202003-3
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu Y, Pan D, He L, Rong X, Li H, Li Y, Pi Y, Xu Y, Tang Y. China Registry Study on Cognitive Impairment in the Elderly: Protocol of a Prospective Cohort Study. Front Aging Neurosci. 2021 Dec 23;13:797704. doi: 10.3389/fnagi.2021.797704. eCollection 2021.
PubMed 35002683
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Ageing People: A Longitudinal Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04360200
- Acronym / sponsor ID
- 202003-3
- Conditions
- MCI, Alzheimer Disease, VAD - Vascular Dementia, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Yamei TangUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 24 Apr 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.
Mild cognitive impairment (MCI) and neurocognitive disorder such as 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. The study will construct a prospective cohort to establish database that provide not only comprehensive epidemiological data on the MCI and neurocognitive disorder in ageing people, but also complete the construction of biological samples bank and clinical diagnosis and treatment information database. Using the database, the study will identify the conversion rates from MCI to dementia and risk factors for the progression from MCI to dementia or AD. The study will also apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study have goals to identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of cognitive disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Aging | – | –Normal Aging with normal cognitive function |
| Mild cognitive impairment (MCI) | – | –Mild cognitive impairment subjects with memory loss as predominant symptom |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Chinese aged 50 and up, receiving outpatient or inpatient service of Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Key inclusion criteria (4 listed)
- Patients over 50 years old.
- Sign informed consent.
- According to DSM-IV, the diagnostic standard of dementia was not met.
- The clinical dementia rating (CDR) was 0.5.
Key exclusion criteria (5 listed)
- Subjects with mental retardation.
- Refuse to have blood sampling, imaging and other examinations.
- Uncooperative subjects that have serious organic diseases, or have a history of mental illness, or have physical disability (including severe aphasia).
- Contraindications of MR scanning.
- Suffering from serious physical or mental illness.
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
Incidence of Dementia
Time frame: April 2020 to December 2040
2 secondary outcomes
The conversion rate of normal elderly to MCI to neurocognitive disorder
Time frame: April 2020 to December 2040
Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score
Time frame: April 2020 to December 2040
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 35002683Zhu Y, Pan D, He L, Rong X, Li H, Li Y, Pi Y, Xu Y, Tang Y. China Registry Study on Cognitive Impairment in the Elderly: Protocol of a Prospective Cohort Study. Front Aging Neurosci. 2021 Dec 23;13:797704. doi: 10.3389/fnagi.2021.797704. eCollection 2021.
- Individual participant dataSharing planned: Undecided
Related trials for MCI
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Recruiting
ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life
Hearing Loss, Cognitive Impairment, Mild
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease
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.
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 MCI and Alzheimer Disease, run by Yamei Tang 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 5 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang (+86-020-34070569, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dementia (time frame: April 2020 to December 2040). 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 NCT04360200, 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 14 Sep 2020.