Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The project of Bio-AD is a population- based cohort study among the elderly in China. The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function. The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data. The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Written informed consent obtained from participant or legal guardian prior to any study-related procedures.

• Aged 18 (inclusive) or older.

• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales.

• Follow up 5 years and collect the information.

Locations
Other Locations
China
Xuanwu Hospital of Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jianping Jia, Doctor
jiajp@vip.126.com
#8610-83199449
Time Frame
Start Date: 2020-05-28
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 6000
Treatments
AD group
Dementia is diagnosed according to the 2011 NIA-AA criteria.
MCI group
aMCI diagnosed according to the criteria of 2004 Peterson.
pre-MCI group
β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment; not up to MCI or cognitive impairment.
Other neurodegenerative diseases
Frontotemporal Dementia; or Parkinson's disease
Cognitive normal group
Individuals are with normal cognitive function and ≥ 60 years old.
Related Therapeutic Areas
Sponsors
Leads: Capital Medical University

This content was sourced from clinicaltrials.gov