Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood of Alzheimer's Disease
Alzheimer's Biomarker Study: Finding the Best Diagnostic Clues
Plain English Summary
The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease is a Not Applicable clinical trial sponsored by Capital Medical University studying Alzheimer's Disease. This study aims to find the most accurate levels of certain substances in spinal fluid and blood to help diagnose Alzheimer's disease. It is for individuals aged 55-75 who have Alzheimer's disease, mild memory problems, other types of dementia, or are cognitively healthy. Participation involves providing informed consent, undergoing cognitive tests, and giving samples of blood and spinal fluid. Currently, diagnosis often relies on a combination of cognitive tests and imaging, but this study seeks to refine the use of specific biomarkers. The trial aims to enroll 3200 participants.
Official Summary
The participant in this study includes Alzheimer's disease (AD including familial AD and sporadic AD) patients, amnestic mild cognitive impairment (aMCI) patients, non-AD dementia patients and cognitively normal control. The purpose of this study is to establish the best cut-off value of cerebrospinal fluid (CSF) and blood β-amyloid (Aβ) 42/40, total tau (t-tau) , phosphorylated tau ,inflammatory factors, etc. in diagnosis of Alzheimer's disease (AD).
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 a confirmed diagnosis of Alzheimer's disease, mild cognitive impairment, or another form of dementia, or are cognitively normal. You cannot join if you have other significant medical or psychiatric conditions that could affect cognitive function or test results. You must be able to complete cognitive tests and provide biological samples (blood and spinal fluid). 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 will help determine the specific levels of certain substances in your spinal fluid and blood that are most likely to indicate Alzheimer's disease, improving diagnostic acc The specific primary outcome measures are: The cut-off value in diagnosing AD (1 year); The receiver operating characteristic curve (1 year); Relationship between biomarker and clinical symptom (1 year). 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 is important because it seeks to establish more precise and reliable blood and spinal fluid markers for diagnosing Alzheimer's disease, potentially leading to earlier and more accurate dete This research targets Alzheimer's Disease, where improved treatment options are needed.
Investor Insight
This observational study focuses on refining diagnostic tools for a large and growing market, with potential implications for future diagnostic test development and early intervention strategies. The large enrollment target of 3200 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific biomarkers being studied and how the results might impact your diagnosis and treatment options. Be prepared for regular visits for cognitive assessments and sample collection, which may include a lumbar puncture for spinal fluid. Ensure you have a reliable person who can provide information about your cognitive and daily functioning if needed. 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: 3,200 participants
Primary Outcomes
- The cut-off value in diagnosing AD (1 year)
- The receiver operating characteristic curve (1 year)
- Relationship between biomarker and clinical symptom (1 year)
Secondary Outcomes
- The sensitivity (1 year)
- The specificity (1 year)
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. The diagnosis of aMCI is assigned according to 2004 Petersen criteria. As for non-AD dementia, the McKeith criteria are used for DLB, the revised diagnostic criteria proposed by the International bvFTD Criteria Consortium for behavioral variant FTD, 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 NCT05020106?
NCT05020106 is a Not Applicable OBSERVATIONAL study titled "The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease." It is currently recruiting and is sponsored by Capital Medical University. The trial targets enrollment of 3200 participants.
What conditions does NCT05020106 study?
This trial investigates treatments for Alzheimer's Disease. The primary condition under study is Alzheimer's Disease.
What does Not Applicable mean for NCT05020106?
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 NCT05020106?
This trial is currently "Recruiting." It started on 2018-09-01. The estimated completion date is 2027-09-01.
Who is sponsoring NCT05020106?
NCT05020106 is sponsored by Capital Medical University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05020106?
The trial aims to enroll 3200 participants. The trial is currently recruiting and accepting new participants.
How is NCT05020106 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05020106?
The primary outcome measures are: The cut-off value in diagnosing AD (1 year); The receiver operating characteristic curve (1 year); Relationship between biomarker and clinical symptom (1 year). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05020106 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT05020106?
The official record for NCT05020106 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05020106. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05020106 testing in simple terms?
This study aims to find the most accurate levels of certain substances in spinal fluid and blood to help diagnose Alzheimer's disease. It is for individuals aged 55-75 who have Alzheimer's disease, mild memory problems, other types of dementia, or are cognitively healthy.
Why is this trial significant?
This trial is important because it seeks to establish more precise and reliable blood and spinal fluid markers for diagnosing Alzheimer's disease, potentially leading to earlier and more accurate dete
What are the potential risks of participating in NCT05020106?
The main risks are associated with the procedures, such as discomfort or bruising from blood draws, and potential headaches or minor pain from spinal fluid collection. There is a small risk of infection or bleeding at the site of the spinal fluid collection. Cognitive tests can be tiring, and some individuals may experience temporary anxiety or distress when discussing cognitive changes. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05020106?
Ask your doctor about the specific biomarkers being studied and how the results might impact your diagnosis and treatment options. Be prepared for regular visits for cognitive assessments and sample collection, which may include a lumbar puncture for spinal fluid. Ensure you have a reliable person who can provide information about your cognitive and daily functioning if needed. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05020106 signal from an investment perspective?
This observational study focuses on refining diagnostic tools for a large and growing market, with potential implications for future diagnostic test development and early intervention strategies. 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 informed consent, undergoing cognitive tests, and giving samples of blood and spinal fluid. 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.