Clinical Trials for Alzheimer's Disease

It can take 15 years for a potential Alzheimer’s disease treatment to work its way from the laboratory to rigorous testing and finally, approval by the Food and Drug Administration (FDA). The process begins in the lab with basic investigations using cells and specially bred animal models. Next, translational research moves the therapy to the human setting. Finally, the drug is tested on humans in clinical trials divided into three phases, I, II and III. These trials are used to determine the safety and effectiveness of the drug on progressively larger numbers of people. Normally, if the results are positive in the first two phases, the therapy will proceed to Phase III. The data gathering, analysis and reporting that are necessary to complete these trials can take several years. Currently, there are approximately 50 potential treatments for Alzheimer’s disease in various clinical testing phases.

Those with Alzheimer’s disease or even healthy individuals may want to consider participating in clinical trials. Each trial has its own protocol or set of guidelines, and volunteers must meet certain criteria to qualify for inclusion. Before making a decision, get as much information as possible about the trials, and think seriously about the benefits and risks of volunteering. Those who participate will have access to potential new treatments, as well as medical care, and they may help others with Alzheimer’s disease. However, there may be side effects to the medications being tested or they may not be effective, and participation requires a certain time commitment.

Further Information

There are several websites that offer information about ongoing private and federally sponsored clinical trials testing Alzheimer’s treatments.

• View a full list of resources for clinical trials research.
• The Pharmaceutical Research and Manufacturers of America (www.phrma.org) provides access to a database that includes Alzheimer’s medicines currently in clinical trials or at the FDA for review.
• The National Institute on Aging has very helpful information concerning clinical trials and the elderly population, as well as a fact sheet concerning participation in Alzheimer’s disease clinical trials and studies.

Last Reviewed On: 12/16/09