What is clinical research?

Clinical research is patient-oriented research and is one part of the process used to develop new medical treatments and technology. Clinical trials, or the specific research studies, are conducted in human volunteers - called study subjects - or on samples collected from human volunteers. Each trial is designed to answer specific questions and may be related to developing new treatments, new procedures, or new medical devices. Deciding to participate in a clinical research study is an important personal decision that should be carefully considered. For more information on clinical research trials, please download our Clinical Research flyer (requires free Adobe Acrobat Reader).

Tell me about the research studies.

Each research study conducted by the WCMP has a unique design which will be discussed with you in detail prior to your participation. Some current studies are investigating potential new treatments for memory disorders, such as Alzheimer's disease. Other studies might use new brain imaging techniques to aid in the detection of slight memory changes, or might ask participants to try out new memory tests so that they can be used in future clinical trials. Some studies might ask to follow participants over a period of time to observe changes in their daily function while they undergo treatment for other conditions such as cancer, and others might investigate a combination of these techniques to explore the possible prevention of memory loss.

Because the studies vary in their purpose, the length of the study, and the number and frequency of study visits also varies. Generally, however, all WCMP studies require at least one visit to the research center. Research visits typically last about 2 - 3 hours, though some may be shorter or longer. Studies that involve an investigational medication may require frequent visits, every 6 to 12 weeks, because the study team will be closely monitoring you for any potential side effects of the treatment. Any investigational medications you are asked to take, or any procedures or evaluations that you are asked to complete as part of the research study, will be provided to the participants at no charge. Often, research studies enrolling persons with memory loss will also require a study partner to accompany you to the research visits.

What if I change my mind?

There's no pressure. You are free to withdraw from a study at any time and for any reason.

What would I have to do?

At your first visit, the research study and all of the elements required for participation will be discussed with you in detail, including the study visit schedule, all of the study procedures that you or your study partner will be asked to complete, the risks and benefits, and your rights as a study volunteer, including your right to withdraw from the study. Following this discussion, you will be asked to sign the study consent form which will serve as the written documentation that the study has been explained to you and that you have voluntarily agreed to participate. After you have signed the consent form, you will be "screened" for your eligibility to participate in the study. Participant screening helps to ensure that researchers will be able to appropriately and accurately answer the research question, and helps to protect the safety of potential subjects. Screening may involve review of your medical history and current medications, physical and neurological examinations performed by the study physician, blood tests, electrocardiogram, or brain imaging.

Once you have agreed to participate, and it has been determined that it is safe for you to proceed with the study, you will be scheduled for the remainder of the study visits.

The remaining study visits will typically include:

• Questions about how you are feeling and about what medications you are taking.
• Paper and pencil tests examining memory and other thinking abilities.
• A blood draw taken in order to monitor changes in blood chemistry, and if applicable, changes in the level of investigational medication in your blood, throughout the study.
• Additional physical examinations by the study physician as needed to further monitor safety.

Some of our studies include:

• Tests designed to measure a person’s ability to manage day-to-day tasks. These tests might include activities such as making a bed, doing the laundry, vacuuming a floor, and other “household” tasks. These tests are unique to our studies and are designed to see if receiving standard treatments for diseases such as cancer , or if taking certain investigational medications for memory disorders, can affect a person’s ability to perform tasks of independent living.