Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）
New Blood Test Aims to Detect Alzheimer's Early
Plain English Summary
Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis is a Not Applicable clinical trial sponsored by Capital Medical University studying Alzheimer's Disease. This study is testing a new blood test designed to detect early signs of Alzheimer's disease. It is for individuals aged 55-75 who may have Alzheimer's or other forms of dementia, as well as those with normal cognitive function. Participation involves providing blood samples and undergoing cognitive assessments. Currently, Alzheimer's diagnosis often relies on more invasive tests or clinical observation. The trial aims to enroll 1500 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 55 and 75 years old and have been diagnosed with Alzheimer's disease or another type of dementia, or if you have normal cognitive function. You cannot join if you have other significant medical or psychiatric illnesses that could affect cognitive function. You must be willing to provide informed consent, complete cognitive tests, and give blood samples. This trial is studying Alzheimer's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the new blood test can accurately identify Alzheimer's disease compared to other conditions, aiming for a high level of accuracy within two years. The specific primary outcome measures are: The area under curve of the AD-seeds-detector for the accurate diagnosis of AD (two years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to develop a simpler, less invasive blood test to accurately diagnose Alzheimer's disease, potentially filling a gap in early and accessible diagnostic tools. This research targets Alzheimer's Disease, where improved treatment options are needed.
Investor Insight
This trial signals a significant investment in developing non-invasive Alzheimer's diagnostics, a market with high demand due to the growing aging population and the limitations of current diagnostic The large enrollment target of 1500 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this blood test could be right for you and what the results might mean. Participation involves regular visits for blood draws and cognitive tests over a two-year period. Be prepared to discuss your medical history and any other conditions you have. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 1,500 participants
Primary Outcomes
- The area under curve of the AD-seeds-detector for the accurate diagnosis of AD (two years)
Secondary Outcomes
- The sensitivity (two years)
- The specificity (two years)
- The positive predictive value (two years)
- The negative predictive value (two years)
- Cellular toxcity of Aβ seeds protein (two years)
Full Eligibility 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.
Trial Locations
- Xuanwu Hospital of Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
What is clinical trial NCT04850053?
NCT04850053 is a Not Applicable OBSERVATIONAL study titled "Detection of Alzheimer's Disease (AD)-Related Seeds for AD Diagnosis." It is currently recruiting and is sponsored by Capital Medical University. The trial targets enrollment of 1500 participants.
What conditions does NCT04850053 study?
This trial investigates treatments for Alzheimer's Disease. The primary condition under study is Alzheimer's Disease.
What does Not Applicable mean for NCT04850053?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04850053?
This trial is currently "Recruiting." It started on 2020-08-26. The estimated completion date is 2026-12-31.
Who is sponsoring NCT04850053?
NCT04850053 is sponsored by Capital Medical University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04850053?
The trial aims to enroll 1500 participants. The trial is currently recruiting and accepting new participants.
How is NCT04850053 designed?
This is a observational study.
What are the primary outcomes being measured in NCT04850053?
The primary outcome measures are: The area under curve of the AD-seeds-detector for the accurate diagnosis of AD (two years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04850053 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT04850053?
The official record for NCT04850053 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04850053. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04850053 testing in simple terms?
This study is testing a new blood test designed to detect early signs of Alzheimer's disease. It is for individuals aged 55-75 who may have Alzheimer's or other forms of dementia, as well as those with normal cognitive function.
Why is this trial significant?
This trial matters because it aims to develop a simpler, less invasive blood test to accurately diagnose Alzheimer's disease, potentially filling a gap in early and accessible diagnostic tools.
What are the potential risks of participating in NCT04850053?
The main risks are related to blood draws, such as bruising or minor discomfort. There is a small risk of infection at the blood draw site. Potential side effects are generally mild and temporary. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04850053?
Ask your doctor if this blood test could be right for you and what the results might mean. Participation involves regular visits for blood draws and cognitive tests over a two-year period. Be prepared to discuss your medical history and any other conditions you have. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04850053 signal from an investment perspective?
This trial signals a significant investment in developing non-invasive Alzheimer's diagnostics, a market with high demand due to the growing aging population and the limitations of current diagnostic This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood samples and undergoing cognitive assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.