Study on Biomarkers for Early Diagnosis of Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Under age 18.
Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
No one can serve as a study informant.
With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
Trial population
The study population was calculated according to objectives of this project. There are five gruops in this cohort, AD, MCI, pre-MCI, normal cognitive subjects and other neurodegenerative disease, respectively. AD gruop include familial AD and sporadic AD. The study population include subjects at different clinical stages of AD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6,000 Participants
are grouped into 5 trial groupsGroup A: AD group
Group B: MCI group
Group C: pre-MCI group
Group D: Other neurodegenerative diseases
Group E: Cognitive normal group
Trial outcomes
Primary outcomes
1
A multiple diagnostic kit for early diagnosis of AD.
A panel of special biomarkers is identified for early diagnosis of AD.
Time frame
An Average of 1 year2
A 5-years risk prediction model for onset and progression of AD among elderly population in China.
A 5-years risk prediction model including multiple factors to predict the onset and progression of AD in China.
Time frame
An Average of 1 yearSecondary outcomes
1
A panel of biomarker with high specificity and sensibility
Screening the biomarker with high specificity and sensibility in body fluid at different clinical stage of AD.
Time frame
An Average of 1 year2
AD-associated genes in Chinese.
AD-associated genes and their risk variants will be identified by whole exome sequencing in this project.
Time frame
An Average of 1 year3
Neuroimaging biomarkers for AD
The certain threshold on neuroimaging biomarkers will be established to distinguish the different clinical stage of AD.
Time frame
An Average of 1 year4
Risks and protective factors for AD among elderly in China
The risks and protective factors of individual and environment will be estimated in this project.
Time frame
An Average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov