NCT04360200

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
175mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2020Dec 2040

Study Start

First participant enrolled

April 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
20.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

20.7 years

First QC Date

April 12, 2020

Last Update Submit

September 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Dementia

    April 2020 to December 2040

Secondary Outcomes (2)

  • The conversion rate of normal elderly to MCI to neurocognitive disorder

    April 2020 to December 2040

  • Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score

    April 2020 to December 2040

Study Arms (2)

Normal Aging

Normal Aging with normal cognitive function

Mild cognitive impairment (MCI)

Mild cognitive impairment subjects with memory loss as predominant symptom

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Humoral biomarkers in plasma, cerebrospinal fluid, stool, and urine

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 24, 2020

Study Start

April 1, 2020

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations