Cognitive Impairment in Ageing People

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Alzheimer Disease; MCI; VAD - Vascular Dementia

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Yamei Tang; Phone Number: +86-020-34070569; Email: yameitang@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Yamet Tang, M. D., Ph. D; Phone Number: 86-020-34070569; Email: yameitang@hotmail.com
      • Principal Investigator: Yamei Tang, M. D., Ph. D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mild cognitive impairment (MCI); Mild cognitive impairment subjects with memory loss as predominant symptom
Normal Aging; Normal Aging with normal cognitive function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Dementia	April 2020 to December 2040

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yamei Tang

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 1, 2040
• Study Completion (Anticipated): December 1, 2040

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Alzheimer Disease; Cognitive Dysfunction; Dementia, Vascular
• Other Study ID Numbers: 202003-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No