Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 4:45 AM
Study NCT ID:
NCT05667935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-29
First Post:
2022-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impairment Cohort Study of the Elderly Population in SheMountain
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SheMountain
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: