Cognitive Impairment Cohort Study of the Elderly Population in YuGarden

NCT ID: NCT06325527

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1872 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2031-06-01

Brief Summary

The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.

The main questions it aims to answer are:

• incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
• to build a predictive model for the progression of cognitive impairment

Detailed Description

This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Cognitive Impairment; Mild Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.

2. Non-AD patients.

3. The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.

4. The participants agree to participate in this study and sign the informed consent form.

Exclusion Criteria

1. Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.

2. Participants who have visual or auditory impairment that hampers the completion of related examination.

3. Situations when magnetic resonance imaging or other examinations are contraindicated.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Wang, MD, PhD

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Gang Wang, MD, PhD

Role: CONTACT

wg11424@rjh.com.cn

086-021-64370045

Facility Contacts

Jinwen Xiao

Role: primary

jw_xiao78@163.com

13917310784

Other Identifiers

YuGarden-01

Identifier Type: -

Identifier Source: org_study_id