TRIAL PARTICIPATION

Northwest Clinical Research Center is conducting a clinical research study evaluating a medication for reducing the severity of agitation and aggression in adults between the ages 55 to 85 with Alzheimer’s disease. Our clinical staff will provide a free evaluation; discuss how clinical trials work, what would be involved if you were to participate, and if participating in this study would be an option. Call our office at 877-453-0404 or complete the questionnaire to get more information about how you can volunteer.

Study participants will receive the following at NO COST:
Medical Evaluation      Medical Care      Study Medication

FREQUENTLY ASKED QUESTIONS ABOUT CLINICAL TRIALS
Why do clinical trials exist?
The United States Food and Drug Administration (FDA) requires that all prescription medications be evaluated for safety and efficacy before they are marketed to the public. So before a new medication can be made available, it must undergo extensive testing. Clinical trials are part of this testing process.

Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate; using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Why should my loved one and I participate in research?
By participating in a clinical trial, you can help move research forward. Without clinical trials, there can be no better treatments, no prevention and no cure for Alzheimer’s disease. Scientists work constantly to find better ways to treat diseases, but improved treatments can never become a reality without testing in clinical trials with human volunteers. Additionally, you can:
      play a more active role in your own health care
      gain access to potential treatments before they are widely available
      compare existing treatments
      receive expert medical care at leading healthcare facilities
      help future generations (your children and grandchildren) by contributing to Alzheimer’s research

What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Does it cost anything to participate in the study?
There is no monetary cost to you to participate in this study, nor do you have to pay for the study drug, visits, or procedures that are a part of the clinical trial.