Cognitive Impairment Cohort Study of the Elderly Population in YuGarden
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort
Overview
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.
Primary outcome measures
- Incidence of cognitive impairment [Time frame: 8 years]
Secondary outcome measures (12)
- The change of Mini-Mental State Examination (MMSE) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Barthel Index for Activities of Daily Living (ADL) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of blood biomarkers [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of urine biomarkers [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of feces biomarkers [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of gingival crevicular fluid biomarkers [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of electroencephalogram (EEG) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of speech information [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of structural MRI [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of functional MRI [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of magnetic susceptibility [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of perfusion MR imaging [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06325527 · YuGarden-01