Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04850053

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Jianping Jia, Doctor

CONTACT

[email protected]

8610-83199449

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

  5. Cellular toxcity of Aβ seeds protein

    Time frame: two years

    Toxcity of Aβ seeds protein on cells

  6. Morphology and structure of Aβ

    Time frame: two years

    Comparison of Morphology and structure of beta-amyloid protein between difference groups

Study contacts

Contact information is provided by the study sponsor or research team.

Jianping Jia, Doctor

CONTACT

[email protected]

8610-83199449

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

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

Registry information

Official study title

Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.