AHEAD Study - Miami, FL - Wien Center for Clinical Research


Details

  • Location:
  • Age: 55 to 80
  • Duration: 4 years
  • Visits: Varies
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Eligibility Requirements

To be eligible for the AHEAD Study, you must:

  • be between the ages of 55 to 80 years 
    • if you are age 55 to 64, you also need to have one of the following additional risk factors:
      • first degree relative diagnosed with dementia onset before age 75,

OR

  • known to have at least 1 copy of the APOE4 gene,

OR

  • known to have elevated brain amyloid based on a prior PET brain scan or CSF (lumbar puncture / spinal tap) testing
  • not been diagnosed with Alzheimer’s disease or another dementia
  • have elevated or intermediate levels of amyloid in their brains determined by brain imaging as part of the study
  • agree to approximately a 4-year commitment in the study involving in-person and telephone visits with study researchers every two to four weeks
  • have a study partner, either close relative or friend, willing to attend some of the study visits
  • able to get an MRI and PET scans

Participants will be compensated for their time.

About the Study:

The AHEAD Study is a new trial aiming to prevent Alzheimer’s disease. It is evaluating whether an investigational treatment (BAN2401 (lecanemab)) can lower the amount of amyloid in the brain and how that impacts decline in memory loss due to Alzheimer’s.


Studies have shown that changes caused by Alzheimer’s occur in the brain many years before a person shows symptoms of the disease. 

Purpose:

The purpose of the AHEAD Study is to determine whether intervention with the investigational anti-amyloid treatment, BAN2401 (lecanemab), can slow the earliest brain changes associated with Alzheimer’s disease and help to prevent the associated memory loss, especially if started early, before symptoms are clinically apparent. The AHEAD Study will help researchers understand what early Alzheimer’s disease changes in the brain, such as specific levels of amyloid, detected with imaging and other biomarker tests, are associated with cognitive decline.  


The AHEAD Study may also help researchers understand why some groups are at increased risk and find the most appropriate treatment for all individuals.

What is Involved:

If you qualify for the AHEAD Study, you will receive the study treatment (investigational treatment [BAN2401 (lecanemab)] or placebo) intravenously (IV) every other week or monthly, depending on whether you are in AHEAD-3 or AHEAD-45. 


Please see study website for additional information: aheadstudy.org

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