Alzheimer's DiseaseNCT04850053
Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis
An observational study of Alzheimer's Disease, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Jianping Jia, Doctor, 8610-83199449, jiajp@vip.126.com
About this study
Official title: Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）
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.
Read the 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).
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (6)
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).
Measured: two years
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).
Measured: two years
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)
Measured: two years
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)
Measured: two years
Cellular toxcity of Aβ seeds protein
Toxcity of Aβ seeds protein on cells
Measured: two years
Morphology and structure of Aβ
Comparison of Morphology and structure of beta-amyloid protein between difference groups
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start26 Aug 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Beijing Geriatric Hospital, Kaifeng Central Hospital, First Affiliated Hospital of Chongqing Medical University, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Jianping Jia, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850053
- Sponsor's protocol ID
- AD-seeds-detector
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jia J, Li T, Yang J, Chen B, Qin W, Wei C, Song Y, Wang Q, Li Y, Jia L. Detection of plasma Abeta seeding activity by a newly developed analyzer for diagnosis of Alzheimer's disease. Alzheimers Res Ther. 2022 Feb 2;14(1):21. doi: 10.1186/s13195-022-00964-2.
PubMed 35109911
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）
- ClinicalTrials.gov ID
- NCT04850053
- Acronym / sponsor ID
- AD-seeds-detector
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Beijing Geriatric Hospital, Kaifeng Central Hospital, First Affiliated Hospital of Chongqing Medical University, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Henan Provincial People's Hospital
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
The sensitivity
Time frame: two years
The specificity
Time frame: two years
The positive predictive value
Time frame: two years
The negative predictive value
Time frame: two years
Cellular toxcity of Aβ seeds protein
Time frame: two years
Morphology and structure of Aβ
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 35109911Jia J, Li T, Yang J, Chen B, Qin W, Wei C, Song Y, Wang Q, Li Y, Jia L. Detection of plasma Abeta seeding activity by a newly developed analyzer for diagnosis of Alzheimer's disease. Alzheimers Res Ther. 2022 Feb 2;14(1):21. doi: 10.1186/s13195-022-00964-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianping Jia, Doctor (8610-83199449, jiajp@vip.126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under curve of the AD-seeds-detector for the accurate diagnosis of AD (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.