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Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis

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ClinicalTrials.gov Identifier: NCT04850053
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
Shandong Provincial Hospital
Xiangya Hospital of Central South University
Zhejiang Provincial People's Hospital
Beijing Geriatric Hospital
Kaifeng Central Hospital
The First Affiliated Hospital of Chongqing Medical Universty
Huashan Hospital
First Affiliated Hospital Xi'an Jiaotong University
West China Hospital
Henan Provincial People's Hospital
Information provided by (Responsible Party):
Jianping Jia, Capital Medical University

Brief Summary:

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.


Condition or disease
Alzheimer's Disease

Detailed Description:

Aβ and Tau seeds have the potential to serve as biomarkers for AD. The AD-seeds-detector could detect small quantities of Aβ and Tau seeds by taking advantage of their ability to nucleate and enhance aggregation, enabling a very high amplification of the signal. This study examines the effectiveness of using the AD-seeds-detector as a novel technique for discriminating AD from cognitively normal control and non-AD dementia by detecting small Aβ and Tau seeds in plasma.

This will be an observational study aiming at using the AD-seeds-detector to detect minute amounts of Aβ and Tau seeds in plasma as novel biomarkers with high sensitivity and specificity for the accurate diagnosis of AD. To achieve this goal, the investigators will conduct two studies using the AD-seeds-detector to detect the Aβ and Tau seeds in the plasma samples.

Study one:

A single-center cohort that consists of well-characterized AD patients (n=150), cognitively normal controls (n=100) and non-AD dementia patients (n=50).

Study two:

A multi-center cohort with well-characterized AD patients (n=400), cognitively normal controls (n=400) and non-AD dementia patients (n=400).

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD(AD-seeds-detector)
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Alzheimer's disease
Criteria for AD according to the 2011 NIA-AA
Non-AD dementia
Frontotemporal dementia (FTD); or Parkinson's disease dementia (PDD); or dementia with Lewy bodies (DLB); or vascular dementia (VaD); or corticobasal degeneration (CBD); or dementia not otherwise specified.
Cognitively normal controls
Individuals with normal cognitive function



Primary Outcome Measures :
  1. The area under curve of the AD-seeds-detector for the accurate diagnosis of AD [ Time Frame: two years ]
    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.


Secondary Outcome Measures :
  1. The sensitivity [ Time Frame: two years ]
    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).

  2. The specificity [ Time Frame: two years ]
    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).

  3. The positive predictive value [ Time Frame: two years ]
    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)

  4. The negative predictive value [ Time Frame: two years ]
    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)


Biospecimen Retention:   Samples With DNA
Blood,cerebral spinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study 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).

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850053


Contacts
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Contact: Jianping Jia, Doctor 8610-83199449 jiajp@vip.126.com

Locations
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China, Beijing
Xuanwu Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Jianping Jia, Doctor    8610-83199449    jiajp@vip.126.com   
Sponsors and Collaborators
Capital Medical University
Shandong Provincial Hospital
Xiangya Hospital of Central South University
Zhejiang Provincial People's Hospital
Beijing Geriatric Hospital
Kaifeng Central Hospital
The First Affiliated Hospital of Chongqing Medical Universty
Huashan Hospital
First Affiliated Hospital Xi'an Jiaotong University
West China Hospital
Henan Provincial People's Hospital
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Responsible Party: Jianping Jia, Chief Director, Capital Medical University
ClinicalTrials.gov Identifier: NCT04850053    
Other Study ID Numbers: AD-seeds-detector
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianping Jia, Capital Medical University:
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders