NCT05667935

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Dec 2022Jan 2031

First Submitted

Initial submission to the registry

December 13, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

December 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2031

Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

8 years

First QC Date

December 13, 2022

Last Update Submit

December 28, 2022

Conditions

Alzheimer DiseaseDementiaNeurodegenerative DiseasesCognitive ImpairmentMild Cognitive Impairment

Keywords

Alzheimer diseaseMild cognitive impairmentcohortDisease Progression

Outcome Measures

Primary Outcomes (1)

  • The change of incidence of cognitive impairment

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

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

Secondary Outcomes (10)

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

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

  • The change of Montreal cognitive assessment-Basic (MoCA)

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

  • The change of Auditory verbal learning test (AVLT)

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

  • The change of Geriatric Depression Scale (GDS)

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

  • The change of 36-Item Short Form Survey (SF-36)

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

  • +5 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
  • Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, morning urine

MeSH Terms

Conditions

Alzheimer DiseaseDementiaNeurodegenerative DiseasesCognitive DysfunctionDisease Progression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental DisordersCognition DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gang Wang, MD, PhD

CONTACT

086-021-64370045wg11424@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

December 13, 2022

First Posted

December 29, 2022

Study Start

December 26, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

January 31, 2031

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

CN(1)