Azeliragon and the STEADFAST Study
Azeliragon, developed by vTv Therapeutics LLC, is an investigational medication. Azeliragon works by blocking a receptor in the brain that is thought to contribute to many different causes of Alzheimer's disease. By blocking this receptor, the progression of Alzheimer's disease may be slowed.
Azeliragon has completed both phase 1 and phase 2 studies. The STEADFAST Study is a phase 3 study, which needs to be completed as one of the last steps before azeliragon can be submitted to the United States Food and Drug Administration (FDA) for review and approval.
The STEADFAST Study will last approximately 23 months and involves about 9 visits to the doctor’s office. Most visits occur every 3 months.
To qualify for the STEADFAST Study, you must be 50 years of age or older with a confirmed diagnosis of mild Alzheimer’s disease. You must already be taking one or more of the following medications for at least 3 months prior to the study:
- memantine (Namenda® or Ebixa®)
- galantamine (Razadyne® or Reminyl®)
You must have a study partner who is also willing to be a part of the STEADFAST clinical trial. Your study partner will need to attend study visits with you and answer questions about your disease.
What Do I Need To Do?
- You will need to attend all study visits with your study partner (spouse, close relative, or someone else who is knowledgeable about your daily activities).
- You will need to take your study medication every day, as instructed.
- You must continue to take your regular Alzheimer’s disease medication as you normally do.
- You will need to tell the doctor in charge of the study about any changes to your health or medications for the duration of the study.
- As part of the qualification process, you will need to participate in a memory screening.