Clinical trial NCT06325527: Cognitive Impairment Cohort Study of the Elderly Population in YuGarden
Official title: Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Disease
Neurodegenerative Diseases
Cognitive Impairment
Mild Cognitive Impairment
Keywords: Alzheimer Disease
Mild Cognitive Impairment
Cohort
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 1872
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Incidence of cognitive impairment
timeFrame: 8 years
Secondary outcomes:
measure: The change of Mini-Mental State Examination (MMSE)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of Barthel Index for Activities of Daily Living (ADL)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of blood biomarkers
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of urine biomarkers
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of feces biomarkers
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of gingival crevicular fluid biomarkers
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of electroencephalogram (EEG)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of speech information
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of structural MRI
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of functional MRI
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of magnetic susceptibility
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of perfusion MR imaging
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: Positron emission tomography (PET)
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Gang Wang, MD, PhD
role: STUDY_CHAIR
References: