Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease

Study seeks biomarkers for early Alzheimer's diagnosis in China.

NCT: NCT04575337 · Status: RECRUITING · Phase: N/A · Sponsor: Capital Medical University · Started: 2020-05-28 · Est. Completion: 2027-06-30

Plain English Summary

Study on Biomarkers for Early Diagnosis of Alzheimer's Disease is a Not Applicable clinical trial sponsored by Capital Medical University studying Alzheimer Disease. This study is looking for biological markers in body fluids, genes, and brain scans to help detect Alzheimer's disease early. It is for elderly individuals in China, including those with normal cognition, mild cognitive impairment, or Alzheimer's disease. Participation involves regular check-ups, cognitive tests, and providing biological samples (like blood) and undergoing brain imaging. Currently, early diagnosis often relies on symptom observation and cognitive tests, with a need for more objective markers. The trial aims to enroll 6000 participants.

Official Summary

The project of Bio-AD is a population- based cohort study among the elderly in China. The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function. The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data. The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older living in China. Individuals with normal cognitive function, mild cognitive impairment, or diagnosed with Alzheimer's disease. Participants must be able to attend follow-up visits for 5 years and provide consent. Individuals with other neurological or psychiatric conditions, a history of substance abuse, or those unwilling to undergo tests are excluded. This trial is studying Alzheimer Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study aims to create tools that can identify Alzheimer's disease in its earliest stages and predict a person's risk of developing or worsening the condition over the next five years. The specific primary outcome measures are: A multiple diagnostic kit for early diagnosis of AD. (An Average of 1 year); A 5-years risk prediction model for onset and progression of AD among elderly population in China. (An Average of 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 aims to fill a critical gap by developing reliable biomarkers for the early detection of Alzheimer's disease, potentially leading to earlier interventions and better patient outcomes. This research targets Alzheimer Disease, where improved treatment options are needed.

Investor Insight

This observational study focuses on biomarker discovery for a major disease, indicating potential future diagnostic market opportunities if successful, though it's not a drug trial. The large enrollment target of 6000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about what specific tests will be involved and how often you'll need to visit. Be prepared for cognitive assessments, blood draws, and potentially brain scans. Understand that you will be followed for up to 5 years to track changes and risks. 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

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
* Aged 18 (inclusive) or older.
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales.
* Follow up 5 years and collect the information.

Exclusion Criteria:

* Under age 18.
* Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
* No one can serve as a study informant.
* With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
* Refused to complete a cognitive test and provide biospecimen.
* With history of alcohol or drug abuse.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04575337?

NCT04575337 is a Not Applicable OBSERVATIONAL study titled "Study on Biomarkers for Early Diagnosis of Alzheimer's Disease." It is currently recruiting and is sponsored by Capital Medical University. The trial targets enrollment of 6000 participants.

What conditions does NCT04575337 study?

This trial investigates treatments for Alzheimer Disease. The primary condition under study is Alzheimer Disease.

What does Not Applicable mean for NCT04575337?

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 NCT04575337?

This trial is currently "Recruiting." It started on 2020-05-28. The estimated completion date is 2027-06-30.

Who is sponsoring NCT04575337?

NCT04575337 is sponsored by Capital Medical University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04575337?

The trial aims to enroll 6000 participants. The trial is currently recruiting and accepting new participants.

How is NCT04575337 designed?

This is a observational study.

What are the primary outcomes being measured in NCT04575337?

The primary outcome measures are: A multiple diagnostic kit for early diagnosis of AD. (An Average of 1 year); A 5-years risk prediction model for onset and progression of AD among elderly population in China. (An Average of 1 year). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04575337 being conducted?

This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).

Where can I find official information about NCT04575337?

The official record for NCT04575337 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04575337. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04575337 testing in simple terms?

This study is looking for biological markers in body fluids, genes, and brain scans to help detect Alzheimer's disease early. It is for elderly individuals in China, including those with normal cognition, mild cognitive impairment, or Alzheimer's disease.

Why is this trial significant?

This trial aims to fill a critical gap by developing reliable biomarkers for the early detection of Alzheimer's disease, potentially leading to earlier interventions and better patient outcomes.

What are the potential risks of participating in NCT04575337?

Risks are generally related to the procedures, such as minor discomfort from blood draws or potential side effects from brain imaging if contrast agents are used. There's a risk that the diagnostic tools developed may not be as accurate as hoped, or that the prediction models may not perfectly forecast disease progression. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04575337?

Ask your doctor about what specific tests will be involved and how often you'll need to visit. Be prepared for cognitive assessments, blood draws, and potentially brain scans. Understand that you will be followed for up to 5 years to track changes and risks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04575337 signal from an investment perspective?

This observational study focuses on biomarker discovery for a major disease, indicating potential future diagnostic market opportunities if successful, though it's not a drug trial. 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 regular check-ups, cognitive tests, and providing biological samples (like blood) and undergoing brain imaging. 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.

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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.