Cognitive Impairment in Ageing People

Alzheimer Disease Clinical Trial

Official title:

Cognitive Impairment in Ageing People: A Longitudinal Observational Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04360200
• Other study ID #: 202003-3
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 2040

Study information

• Verified date: September 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yamei Tang
• Phone: +86-020-34070569
• Email: yameitang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia, Vascular
• MCI
• VAD - Vascular Dementia

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yamei Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dementia		April 2020 to December 2040
Secondary	The conversion rate of normal elderly to MCI to neurocognitive disorder		April 2020 to December 2040
Secondary	Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score		April 2020 to December 2040