What is a clinical trial?
A clinical trial is a research study that involves human volunteers to help answer specific health questions and develop new treatments or interventions related to a medical condition. Clinical research studies help physicians and scientists test these possible interventions that could help diagnose, prevent, treat, and someday cure many medical problems. FDA-approved clinical trials are always preceded by laboratory analyses in test tubes and in tissue culture, followed by studies in laboratory animals to test for safety and efficacy. If these studies show favorable results, then the FDA may give approval for the treatment or intervention to be tested in humans. Currently, there are many clinical research studies underway that will help researchers understand more about the underlying causes and treatments related to Alzheimer’s disease.
Types of clinical trials
Clinical trials advance through four well-defined phases to test the treatment, find appropriate dosage levels, and monitor side effects in the research volunteers.
Phase One: Tests a new drug’s safety in the human body. A small number of healthy volunteers are needed for this phase.
Phase Two: Tests for effectiveness and dosage levels in several hundred research volunteers. Often there are two groups: One group receives the standard treatment or placebo (inactive pill), and the second group receives the experimental treatment.
Phase Three: Measures the drug or procedure against the best standard treatment. This is the last phase before submission to the Food and Drug Administration (FDA) for approval.
Phase Four: The FDA continues to monitor the effects of a new drug after its approval for marketing and clinical use. If problems occur in this phase, the approval may be withdrawn and the drug recalled.
Why are clinical trials important?
Rapid advances in our knowledge about Alzheimer’s disease have led to the development of many promising new drugs and treatments. However, before any drug or therapy can be used in clinical practice, it must be rigorously tested to find out whether it is safe and effective in humans. This means that clinical trials—and volunteer participants—are an essential part of Alzheimer’s research. Advances in our understanding of Alzheimer’s disease and the development of improved treatment strategies are possible thanks to the research volunteers who participate in these clinical trials.
What are the potential benefits of participating in clinical trials?
While there is no guarantee that you will benefit from participating in a clinical research study, there are numerous potential benefits, including:
How can I find out more information about Alzheimer’s disease clinical trials?
Information about Alzheimer’s disease clinical trials is available through a number of sources. First, talk with your doctor, who may know about local or specific research studies that may be right for you. The University of Kentucky Alzheimer’s Disease Center at the Sanders-Brown Center on Aging may be conducting clinical trials in your area and they can be contacted for more information at (859) 323-5550 or www.centeronaging.uky.edu. To search more widely for clinical trials, you can also visit websites like www.clinicaltrials.gov, the Alzheimer’s Disease Education and Referral (ADEAR) Center clinical trials database, or the Alzheimer’s Association Trial Match database.