Cognitive Impairment Cohort Study of the Elderly Population in YuGarden

NCT06325527 | Not Yet Recruiting

• 1 other identifier: YuGarden-01
• Study Type: observational
• Target: 1,872
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Alzheimer Disease; Mild Cognitive Impairment; Cohort

Outcome Measures

Primary Outcomes (1)

• Incidence of cognitive impairment

  Number of participants who covert to mild cognitive impairment (MCI) or AD will be recorded to calculate the incidence.

  8 years

Secondary Outcomes (13)

• The change of Mini-Mental State Examination (MMSE)

  baseline, 2 year, 4 year, 6 year, 8 year

• The change of Barthel Index for Activities of Daily Living (ADL)

  baseline, 2 year, 4 year, 6 year, 8 year

• The change of blood biomarkers

  baseline, 2 year, 4 year, 6 year, 8 year

• The change of urine biomarkers

  baseline, 2 year, 4 year, 6 year, 8 year

• The change of feces biomarkers

  baseline, 2 year, 4 year, 6 year, 8 year

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population in this study includes permanent residence in YuGarden community in Shanghai with all genders and all ethnic groups aged between 60 and 85.

You may qualify if:

• The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
• Non-AD patients.
• 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.
• The participants agree to participate in this study and sign the informed consent form.

You may not qualify if:

• 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.
• Participants who have visual or auditory impairment that hampers the completion of related examination.
• Situations when magnetic resonance imaging or other examinations are contraindicated.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, urine, feces, gingival crevicular fluid

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Gang Wang, MD, PhD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Gang Wang, MD, PhD

CONTACT

086-021-64370045; wg11424@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 22, 2024

Record last verified: 2024-02

Locations

CN (1)