FAQs for Clinical Trial Research

Have a question about Clinical Trial Research? See below. If it’s not answered below, please contact us.

What is a clinical trial?

A clinical trial is a research study in which eligible volunteers participate in a protocol by which experimental treatments are tested. Each trial has specific criteria for participation, as well as assessments, timeline for participation, and drug administration. All clinical trials are conducted by a qualified team of professionals and are approved by the Food and Drug Administration (FDA) and an Institutional Review Board (IRB). Experimental treatments and protocols are designed by scientists who may work at a university or a pharmaceutical biotech company. Drugs are tested in phases, as shown in the table below, to test safety and efficacy endpoints.

Phase Subject Population Purpose
Phase I • Healthy volunteers
• Sometimes the patient population
• 100 participants or less
• Establish the drug’s safety profile
Phase II • Disease-specific volunteers
• Several hundred participants
• Determine the best dose
• Continue establishing a safety profile
Phase III • Disease-specific volunteers
• Several hundred participants
• Prove efficacy (i.e., that the drug does what it is intended to do)
• Continue collecting safety data
• Determine the best dose
Phase IV • Disease-specific volunteers
• Several hundred participants
• Post marketing effects

Why should I participate in a clinical trial?

The biggest obstacle to finding a cure for Alzheimer’s disease is a lack of participation in clinical trials. We can only find a cure through research. Furthermore, since there are no existing cures, participation in research provides an additional opportunity for treatment not available through typical clinical care. In addition to helping others and the advancement of science, participating in a clinical trial allows access to new research treatments before they may become available to the public. During a clinical trial, subjects interact with a specialized team that offers careful monitoring as well as valuable resources for coping, information, and community referrals.

Isn’t there a chance I will get a placebo?

Yes, most studies include a chance of receiving a placebo. 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. 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. It is important to remember that although there may only be a 50% of receiving the experimental treatment in a clinical trial, there is a 0% chance of receiving the treatment if you do not participate.

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.

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.

If you have any additional questions, please feel free to contact us.

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