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

Sponsor

Capital Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04850053

Collaborator

Shandong Provincial Hospital (Other), Xiangya Hospital of Central South University (Other), Zhejiang Provincial People's Hospital (Other), Beijing Geriatric Hospital (Other), Kaifeng Central Hospital (Other), The First Affiliated Hospital of Chongqing Medical Universty (Other), Huashan Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), West China Hospital (Other), Henan Provincial People's Hospital (Other)

1,500

Enrollment

Location

40.1

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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).

Study Design

Study Type:

Observational

Anticipated 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 :

Aug 26, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

The area under curve of the AD-seeds-detector for the accurate diagnosis of AD [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

The sensitivity [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).
The specificity [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).
The positive predictive value [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)
The negative predictive value [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)
Cellular toxcity of Aβ seeds protein [two years]
Toxcity of Aβ seeds protein on cells
Morphology and structure of Aβ [two years]
Comparison of Morphology and structure of beta-amyloid protein between difference groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital of Capital Medical University	Beijing	Beijing	China	100053

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianping Jia, Chief Director, Capital Medical University

ClinicalTrials.gov Identifier:

NCT04850053

Other Study ID Numbers:

AD-seeds-detector

First Posted:

Apr 20, 2021

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD: