Clinical trial NCT05667935: Cognitive Impairment Cohort Study of the Elderly Population in SheMountain
Official title: Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Disease
Dementia
Neurodegenerative Diseases
Cognitive Impairment
Mild Cognitive Impairment
Keywords: Alzheimer disease
Mild cognitive impairment
cohort
Disease Progression
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population in this study includes permanent residence in SheMountain Town, Songjiang District (suburbs), Shanghai with all genders and all ethnic groups aged 60 and above.

Brief summary: This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood, APOE genotype, brain MRI, speech information, AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET were collected and analyzed. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.

Detailed description: This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood serum Aβ40, Aβ42, p-tau 181, 217, urine proteomic analysis, APOE genotype analysis, brain MRI, and speech information were collected and analyzed. After initial screening 20% of patients with clinically confirmed MCI and AD were randomly selected for AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.

Eligibility criteria: Inclusion Criteria:

1. All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
2. Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
3. Agree to participate in this study and sign the informed consent form. And promise to abide by the research procedures, and cooperate with the implementation of the whole process of research

Exclusion Criteria:

1. Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
2. Uncorrectable visual or auditory impairment that hampers the completion of related examination.

Primary outcomes:
measure: The change of incidence of cognitive impairment
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
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 Montreal cognitive assessment-Basic (MoCA)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of Auditory verbal learning test (AVLT)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of Geriatric Depression Scale (GDS)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of 36-Item Short Form Survey (SF-36)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of MRI neuroimaging
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: Positron emission tomography (PET)-CT
timeFrame: baseline
measure: The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ)
timeFrame: baseline, 2 year, 4 year, 6 year, 8 year
measure: The change of Activities of daily living (ADL)
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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: