CLINICAL TRIAL RESEARCH FOR MEMORY AND AGE-RELATED DEMENTIA
A clinical trial is a research study in which qualifying volunteers participate in a protocol where experimental treatments are tested. All clinical trials are conducted by a qualified team of professionals. Experimental treatments and protocols are designed by scientists who may work at a university or a pharmaceutical biotech company. These entities contract with qualified professionals and sites to conduct clinical trials. Clinical trial research is highly regulated by the Food and Drug Administration (FDA) and Institutional Review Boards (IRB), with subject safety being of paramount importance.
Clinical trials are conducted in phases, as described in the table below.
Each trial has specific criteria for participation, as well as assessments, timeline for participation, and drug administration. For more information on clinical trials we are conducting at The CRCNJ, please click here.
Since there is no known cure for Alzheimer's disease or memory loss, patients may want to consider participation in a clinical trial to gain access to experimental treatments. Clinical trials give participants the ability to play a more active role in their own health care, and access to cutting-edge technology (including highly specialized brain imaging), routine monitoring, and evaluation by a team of specialists. Participation in the clinical trial is at no cost to subjects, and can help others by contributing to medical research. During a clinical trial, subjects interact with a specialized team that offers valuable resources for coping, information, and community referrals.
The most important reason to participate in a clinical trial is because we need a cure for Alzheimer's disease.
Isn’t there a chance I will get a placebo?
Yes, most studies include a chance of receiving a placebo. One reason for including a placebo group is because of the known “placebo effect”: patients in clinical trials often do better than those not in trials, including those on placebo. Although there may not be a 100 percent chance of receiving the experimental treatment in a clinical trial, there is a zero percent chance of receiving the treatment if you do not participate. Some clinical trials offer an “open-label phase,” in which subjects who complete the “blinded” phase of the trial will be offered an opportunity to take an active dose of drug for a period of time and continue to be monitored.
What happens with my medical care while in a clinical trial?
While in a clinical trial, you will be assessed and monitored by a specialized team, including physicians, neuropsychologists, and study coordinators. Clinical trial participation does not replace your regular medical care or continuation of medications you are currently taking. Participants are advised to continue with all regular doctor visits and remain on all current medications. With your permission, we will keep your doctors informed of your clinical trial participation.
Does trial participation cost me any money?
No, participating in a clinical trial will not cost you any money. All procedures required in the trial are paid for by the sponsor of that particular study. In fact, some studies compensate participants for their time and travel expenses through a stipend.
How do I know if I am eligible to participate?
The best way to determine if you are eligible is to contact us. Participation criteria differ from study to study and may be based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Would you like to find out if you or a loved one are eligible for a clinical trial? Click here.