There is currently no cure for Alzheimer’s disease. As such, researchers are working hard at identifying new methods to try and treat the disease. This requires many kinds of studies, including some that are designed to evaluate the effectiveness of new treatments and therapies.
People who volunteer for these research studies play a very valuable role in this process. Without volunteers, there would be no new drugs, treatments and therapies available to fight Alzheimer’s disease or other medical conditions. Joining a study can help advance research, but it also gives participants access to treatments and therapies not currently available to the general public. This is important to people for whom established therapies have not been effective.
A common question for people considering participation in a clinical trial is whether or not the research study is safe for the participant? By the time a new treatment is available to be tested by people, it’s been carefully studied for years in laboratories and evaluated thoroughly for safety. In order for a trial to be approved for a specific site it must also be approved and then monitored by an Institutional Review Board (IRB). The IRB serves as an ethics committee as its members review research studies and related activities. The IRB’s role is to protect the rights and welfare of clinical trial participants. These procedures help monitor if the clinical trial is being conducted properly and how to deal with any issues that could possibly arise from participation in the clinical trial.
Another frequent question that is raised is whether or not you will get the medication or will you be getting the placebo? This is a valid question as most people can be reluctant to participate if they do not believe that they will be getting the actual medication. As the NIA/NIH notes "In undertaking a clinical trial, researchers don’t want to leave anything to chance. They want to be as certain as possible that the results of the testing show whether or not a treatment is safe and effective. The “gold standard” for testing interventions in people is the “randomized, placebo-controlled” clinical trial. That means volunteers are randomly assigned—that is, selected by chance—to either a test group receiving the experimental intervention or a control group receiving a placebo or standard care." When comparing the results from the two groups it can help suggest whether changes in the test group result from the treatment or occur by chance. In many trials, no one—not even the research team—knows who gets the treatment, the placebo, or another intervention.
After a study ends, all of the information will be collected, analyzed and used to determine the effectiveness, safety and potential side effects of the drug. Then U.S. Food & Drug Administration (FDA) medical advisors and specialists will closely review this information before approving any new drug for use by the general public. Even after a new drug is approved, the pharmaceutical companies continue to conduct studies to compare the safety, effectiveness and cost of the new drug with others already on the market. They may also want to determine if a specific therapy can be administered to other populations. Some studies may continue to assess the long-term effects of a drug and its impact on individual quality of life.
If you're interested in participating in a clinical trial see the information below for active clinical trials.
ClinicalTrials.gov www.clinicaltrials.gov
As part of clinical trials, there will be certain criteria that you need to meet in order to participate. For some of these trials you will also undergo a cognitive evaluation to determine if you qualify for that particular study. Sometimes if you have not received a diagnosis for your cognitive difficulties, the researchers may suggest that the individual undergo a more comprehensive neuropsychological evaluation in order to help ascertain what cognitive disorder the individual has which can aid them in determining which study you may qualify for. If you live in the New Jersey or New York area and would like to schedule a neuropsychological evaluation for yourself or a family member in order to determine if there have been any potential cognitive changes that would be atypical or unexpected for your age please contact Dr. Corey Burchette at 201-577-8286 to inquire about scheduling an appointment at the New Jersey Memory Center which is located in Verona, New Jersey. Easily accessible from many points in North Jersey (including Montclair, Upper Montclair, Cedar Grove, Bloomfield, Glen Ridge, Caldwell, West Caldwell, North Caldwell, Totowa, Wayne, Little Falls, West Orange, and many more).