Here are some common questions and answers about clinical research studies.
A clinical research study is a research project done to find out if investigational medications, treatments, or devices are both safe and effective.
Participants in this kind of study get an investigational medication or placebo under the supervision of a doctor and other research professionals. The word “investigational” means the medication is not yet available or FDA approved for use by the public.
By participating in clinical research, volunteers help doctors find new and improved treatments and better ways to provide care. As a study goes on, the doctor and researchers gather more and more information about the investigational treatment. The study results may show that the investigational treatment improves patient outcomes, offers no benefit to patients, or causes patients unexpected harm.
All of these results are important because they advance medical knowledge and help improve patient care. If regulatory agencies review the study results and feel that the investigational treatment is safe and effective, they may approve it for use by the public.
After a clinical research study is finished, all of the information is collected and analyzed to help determine the medication's safety, effectiveness, and side effects. Study participants can talk to their doctor or healthcare provider to find treatment options after completing a study.
Clinical research studies are regulated according to rules set by health authorities. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study. Each research study must also be approved by an ethics committee (EC) or institutional review board (IRB). ECs and IRBs are groups of people who help protect the rights and welfare of people participating in research studies. ECs and IRBs are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people.
Your privacy will also be protected. The research team cannot tell anyone that you are participating in a research study without your permission. All of the information collected during the study will be kept confidential, and your name won't be listed in any reports based on the study.
Yes, you have the right to leave a research study at any time and for any reason. This opportunity is completely voluntary. We encourage you to bring up any questions or concerns with study doctors and staff.
Here are some common questions and answers about the Generation Study.
People choose to participate in clinical studies for several reasons. Some people participate because they want access to the investigational medication and study-related care at no cost. Others participate because they want to contribute to the advancement of medicine and the benefit of future generations who may be affected by the disease.
In the Generation Study, doctors are studying two investigational medications to see if they may prevent the start of Alzheimer's disease symptoms. Eligible participants may have the chance to try one of the two investigational study medications.
The questionnaire will help you determine if you're eligible for Step 2 of the process. If you qualify for Step 2, you will be asked to join GeneMatch and given information for a study site.
GeneMatch, led by Banner Alzheimer's Institute, is a program that matches people to research studies based in part on their genetic information.
GeneMatch will provide you with a quick and painless cheek swab kit to determine which copies of a gene (known as the APOE gene) you have. You will not be told your APOE results as part of the GeneMatch program.
You can opt out of the study at any time, including when you visit the study doctor to learn about your risk of developing Alzheimer's. If you are eligible to learn about your genetic information for the purposes of this study, a study staff member will first explain the benefits and risks of the process.
If you find out you are eligible for the study and decide to continue participating, you will complete the study over multiple no-cost visits.
Study participants will be allowed to receive study medication for at least 60 months (5 years), and possibly up to 96 months (8 years), depending on when you join the study. Each visit will include study-related care, and you're always encouraged to ask questions or express concerns to your study doctor.
The study is being conducted in multiple doctors' office and clinics all over the country. If you take the quick questionnaire and find out you may be eligible to enroll in the Generation Study, you will find out more about options in your area.
Yes! If you know anyone who may be interested in this study, please share this website with them to help advance Alzheimer's research.
If you're interested in being considered for this study, please take the first step in our 3-step process.Let's Go!
Along with participation from people like you, this study brings together some of the best and brightest organizations in the Alzheimer's community:
The study is sponsored by Novartis, a Swiss pharmaceutical company, and Amgen, a biotechnology company based in Thousand Oaks, CA, in collaboration with BAI, with funding from the National Institute on Aging, part of the National Institutes of Health (NIH), as well as the Alzheimer’s Association, FBRI, GHR Foundation and Banner Alzheimer’s Foundation.