A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology

Community screening for Alzheimer's risk using blood tests

NCT: NCT06043700 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: Eisai Limited · Started: 2023-09-12 · Est. Completion: 2028-03-31

Plain English Summary

A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology is a Not Applicable clinical trial sponsored by Eisai Limited studying Alzheimer's Disease. This study tests a new blood test to find people at high risk for Alzheimer's disease, even if they don't have symptoms. It's for individuals aged 50-80 who may have a higher chance of developing Alzheimer's due to family history, genetics, or previous tests. Participation involves providing a blood sample and potentially being referred for further evaluation if the test indicates high risk. Currently, there are no widely available blood tests for Alzheimer's risk, making this a novel approach. The trial aims to enroll 2000 participants.

Official Summary

The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old. If you are 50-64, you need to have a family history of early dementia, a specific gene (APOE4), or prior test results showing brain amyloid. You cannot join if you have serious uncontrolled medical conditions or are currently in another drug trial. This trial is studying Alzheimer's Disease, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how many people are found to have low, medium, or high levels of amyloid in their brain, which is a key indicator for Alzheimer's disease. The specific primary outcome measures are: Number of Participants With Low, Medium, and High Amyloid Pathology (At Screening on Day 1). 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 find a simple blood test to identify individuals at high risk for Alzheimer's, potentially leading to earlier detection and intervention. This research targets Alzheimer's Disease, where improved treatment options are needed.

Investor Insight

This observational study by Eisai is exploring a new diagnostic tool, potentially opening a large market for early Alzheimer's detection if successful, with a high probability of informing future diag The large enrollment target of 2000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this screening is right for you, especially if you have a family history of Alzheimer's. Participation involves a blood draw and potentially follow-up appointments if the results suggest a high risk. The study is observational, meaning you won't receive any new treatments as part of the trial. The trial is being conducted at 3 sites. 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

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Male or female, age 50 to 80 years inclusive, at the time of informed consent

   \- Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:
   * First degree relative with dementia onset before age 75,
   * Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
   * Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
2. Provide written informed consent
3. Willing and able to comply with all aspects of the protocol
4. Willing to be referred to a clinical site if the assessment results meet the criteria

Exclusion Criteria:

1. Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
2. Participation in an interventional clinical trial study at the time of consent

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06043700?

NCT06043700 is a Not Applicable OBSERVATIONAL study titled "A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology." It is currently active, not recruiting and is sponsored by Eisai Limited. The trial targets enrollment of 2000 participants.

What conditions does NCT06043700 study?

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

What treatments are being tested in NCT06043700?

The interventions being studied include: No Intervention (OTHER). No treatment intervention will be administered.

What does Not Applicable mean for NCT06043700?

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 NCT06043700?

This trial is currently "Active, Not Recruiting." It started on 2023-09-12. The estimated completion date is 2028-03-31.

Who is sponsoring NCT06043700?

NCT06043700 is sponsored by Eisai Limited. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06043700?

The trial aims to enroll 2000 participants. The trial status is active, not recruiting.

How is NCT06043700 designed?

This is a observational study.

What are the primary outcomes being measured in NCT06043700?

The primary outcome measures are: Number of Participants With Low, Medium, and High Amyloid Pathology (At Screening on Day 1). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06043700 being conducted?

This trial is being conducted at 3 sites, including Clermont, Florida; Lady Lake, Florida; District Heights, Maryland (United States).

Where can I find official information about NCT06043700?

The official record for NCT06043700 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06043700. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06043700 testing in simple terms?

This study tests a new blood test to find people at high risk for Alzheimer's disease, even if they don't have symptoms. It's for individuals aged 50-80 who may have a higher chance of developing Alzheimer's due to family history, genetics, or previous tests.

Why is this trial significant?

This trial matters because it aims to find a simple blood test to identify individuals at high risk for Alzheimer's, potentially leading to earlier detection and intervention.

What are the potential risks of participating in NCT06043700?

The main risk is the potential for anxiety or distress if the blood test indicates a high risk for Alzheimer's. As with any blood draw, there's a small risk of bruising or infection at the needle site. There are no direct treatment-related side effects as this is a screening study. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06043700?

Ask your doctor if this screening is right for you, especially if you have a family history of Alzheimer's. Participation involves a blood draw and potentially follow-up appointments if the results suggest a high risk. The study is observational, meaning you won't receive any new treatments as part of the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06043700 signal from an investment perspective?

This observational study by Eisai is exploring a new diagnostic tool, potentially opening a large market for early Alzheimer's detection if successful, with a high probability of informing future diag 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 a blood sample and potentially being referred for further evaluation if the test indicates high risk. 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.