Participating in a Trial or Study
How Can People Find Out About Alzheimer’s Disease Trials and Studies?
Information about Alzheimer’s disease clinical trials and studies is available through a number of sources. First, talk to your doctor, who may know about local or specific research studies that may be right for you. NIA-supported Alzheimer’s Disease Centers or specialized memory or neurological clinics in your community may also be conducting trials. You might also learn of clinical trials through newspapers or other media. To search more widely for trials or studies, you can also visit web sites like ClinicalTrials.gov or the NIA Alzheimer’s Disease Education and Referral (ADEAR) Center clinical trials database. See the “For More Information” section at the end of this fact sheet for resources and contact information.
What Happens When a Person Joins a Clinical Trial?
First, it is important to learn as much as you can about the trial. Staff members at the research center are trained to explain the trial in detail and describe possible risks and benefits. They clarify participants’ rights. Participants and their families can have this information repeated until they are sure they understand it.
After questions are answered, participants sign an informed consent form, which contains key facts about the trial. Next, they are screened by clinical staff to see whether they meet criteria to participate in the trial. Screening examines the characteristics people must have to participate in a particular trial, as well as characteristics that may exclude them. The screening may involve cognitive and physical tests that provide baseline information to compare with future changes. If participants meet all criteria, they are enrolled in the trial.
Informed Consent
Each participant must sign an informed consent agreement, affirming that he or she understands the trial and is willing to participate. Laws and regulations regarding informed consent differ across States and institutions, but they are all meant to ensure participant safety and protection, and to prevent unethical experimentation on vulnerable populations.
Researchers conducting clinical Alzheimer’s research must consider the declining memory and cognitive abilities of people with this disease or another dementia and must evaluate their ability to understand and consent to participate in research. If the person with Alzheimer’s is deemed unable to provide informed consent because of problems with memory and confusion, an authorized legal representative, or proxy (usually a family member), may be able to give permission for the person to participate, particularly if it is included in the patient’s durable power of attorney. A durable power of attorney is a legal agreement designating who will handle the patient’s affairs when he or she no longer can. NIA’s Legal and Financial Planning for People with Alzheimer’s Disease Fact Sheet provides more information.