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Cognitive Impairment in Ageing People

Sponsor
Yamei Tang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04360200
Collaborator
(none)
5,000
Enrollment
1
Location
248
Anticipated Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cognitive Impairment in Ageing People: A Longitudinal Observational Prospective Study
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2040
    Anticipated Study Completion Date :
    Dec 1, 2040

    Arms and Interventions

    Arm Intervention/Treatment
    Normal Aging

    Normal Aging with normal cognitive function
    Mild cognitive impairment (MCI)

    Mild cognitive impairment subjects with memory loss as predominant symptom

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Dementia [April 2020 to December 2040]

    Secondary Outcome Measures

    1. The conversion rate of normal elderly to MCI to neurocognitive disorder [April 2020 to December 2040]

    2. Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score [April 2020 to December 2040]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients over 50 years old.

    2. Sign informed consent.

    3. According to DSM-IV, the diagnostic standard of dementia was not met.

    4. The clinical dementia rating (CDR) was 0.5.

    Exclusion criteria:

    1. Subjects with mental retardation.

    2. Refuse to have blood sampling, imaging and other examinations.

    3. Uncooperative subjects that have serious organic diseases, or have a history of mental illness, or have physical disability (including severe aphasia).

    4. Contraindications of MR scanning.

    5. Suffering from serious physical or mental illness.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510120

    Sponsors and Collaborators

    • Yamei Tang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yamei Tang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT04360200
    Other Study ID Numbers:
    • 202003-3
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Sep 14, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Dementia, Vascular
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Sep 14, 2020