Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-75
SponsorCapital Medical University
About this trial
The study will investigate the biomarkers of Aβ and Tau seeds in plasma detected by Alzheimer's disease (AD) related seeds quantitative detector (AD-seeds-detector), and their sensitivity and specificity in diagnosing AD, compared with those from age-matched cognitively normal controls, and those with other types of dementia.
To perform a high throughput analysis of the amount of Aβ and Tau seeds, the investigators have developed an AD-seeds-detector, in which a fluorescence microplate reader was combined with an oscillating mixer or water-bath-type ultrasonicator.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 55-75. Written informed consent obtained from participant or legal guardian prior to any study-related procedures. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. As for non-AD dementia, the McKeith criteria are used for DLB,the revised diagnostic criteria proposed by the International behavioral variant (bvFTD) Criteria Consortium for bvFTD,the Gorno-Tempini criteria for the semantic variant FTD or non-fluent aphasia, the Movement Disorder Society Task Force criteria for PDD, the vascular behavioral and cognitive disorders (Vas-Cog) criteria for VaD, the Armstrong's criteria for CBD, the CDC's diagnostic criteria for CJD, etc. In addition, normal cognition is supported by MMSE, CDR and other cognitive function scales.
Disqualifiers
Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
Trial population
Study one: (1) AD patients (n=150); (2) cognitively normal controls (n=100); (3) non-AD dementia patients (n=50). Study two: (1) AD patients (n=400); (2) cognitively normal controls (n=400); (3) non-AD dementia patients (n=400).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 3 trial groupsGroup A: Alzheimer's disease
Group B: Non-AD dementia
Group C: Cognitively normal controls
Trial outcomes
Primary outcomes
1
The area under curve of the AD-seeds-detector for the accurate diagnosis of AD
The area under curve is used to show the ability of the AD-seeds-detector to diagnose AD. The value of area under curve is higher, then the ability of the AD-seeds-detector to diagnose AD is stronger.
Time frame
two yearsSecondary outcomes
1
The sensitivity
The sensitivity is used to show the ability of the AD-seeds-detector to diagnose AD patients, and is represented by true positive/ (true positive +false negative).
Time frame
two years2
The specificity
The specificity is used to show the ability of the AD-seeds-detector to avoid false AD patients and rule out AD patients, and is represented by true negative/ (false positive + true negative).
Time frame
two years3
The positive predictive value
The positive predictive value is used to show the ability of the AD-seeds-detector to correctly label AD patients who test positive, and is represented by true positive / (true positive + false positive)
Time frame
two years4
The negative predictive value
The negative predictive value is used to show the ability of the AD-seeds-detector to correctly label people who test negative, and is represented by true negative / (false negative + true negative)
Time frame
two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Capital Medical University
Lead sponsor
Shandong Provincial Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Beijing Geriatric Hospital
Collaborator
Kaifeng Central Hospital
Collaborator
The First Affiliated Hospital of Chongqing Medical Universty
Collaborator
Huashan Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
West China Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov