Common Questions About Participating in Alzheimer's and Related Dementias Research
How Can I Find Out About Alzheimer’s Trials and Studies?
Check the resources below:
- Ask your doctor, who may know about local research studies that may be right for you.
- Sign up for a registry or a matching service to be invited to participate in studies or trials when they are available in your area.
- Contact Alzheimer’s research centers or memory or neurology clinics in your community. They may be conducting trials.
- Visit the Alzheimers.gov Clinical Trials Finder.
- Look for announcements in newspapers and other media.
- Search ClinicalTrials.gov.
Why Would I Participate in a Clinical Trial?
There are many reasons why you might choose to join an Alzheimer’s or dementia clinical trial. You may want to:
- Help others, including future family members, who may be at risk for Alzheimer’s disease or a related dementia
- Receive regular monitoring by medical professionals
- Learn about Alzheimer’s and your health
- Test new treatments that might work better than those currently available
- Get information about support groups and resource
What Else Should I Consider?
Consider both benefits and risks when deciding whether to volunteer for a clinical trial.
While there are benefits to participating in a clinical trial or study, there are some risks and other issues to consider as well.
Risk. Researchers make every effort to ensure participants’ safety. But, all clinical trials have some risk. Before joining a clinical trial, the research team will explain what you can expect, including possible side effects or other risks. That way, you can make an informed decision about joining the trial.
Expectations and motivations. Single clinical trials and studies generally do not have miraculous results, and participants may not benefit directly. With a complex disease like Alzheimer’s, it is unlikely that one drug will cure or prevent the disease.
Uncertainty. Some people are concerned that they are not permitted to know whether they are getting the experimental treatment or a placebo (inactive treatment), or may not know the results right away. Open communication with study staff can help you understand why the study is set up this way and what you can expect.
Time commitment and location. Clinical trials and studies last days to years. They usually require multiple visits to study sites, such as private research facilities, teaching hospitals, Alzheimer’s research centers, or doctors’ offices. Some studies pay participants a fee and/or reimburse travel expenses.
Study partner requirement. Many Alzheimer’s trials require a caregiver or family member who has regular contact with the person to accompany the participant to study appointments. This study partner can give insight into changes in the person over time.
What Happens When a Person Joins a Clinical Trial or Study?
Once you identify a trial or study you are interested in, contact the study site or coordinator. You can usually find this contact information in the description of the study, or you can contact the ADEAR Center. Study staff will ask a few questions on the phone to determine if you meet basic qualifications for the study. If so, they will invite you to come to the study site. If you do not meet the criteria for the study, don’t give up! You may qualify for a future study.
What Is Informed Consent?
It is important to learn as much as possible about a study or trial to help you decide if you would like to participate. Staff members at the research center can explain the study in detail, describe possible risks and benefits, and clarify your rights as a participant. You and your family should ask questions and gather information until you understand it fully.
After the research is explained and you decide to participate, you will be asked to sign an informed consent form, which states that you understand and agree to participate. This document is not a contract. You are free to withdraw from the study at any time if you change your mind or your health status changes.
Researchers must consider whether the person with Alzheimer’s disease or another dementia is able to understand and consent to participate in research. If the person cannot provide informed consent because of problems with memory and thinking, an authorized legal representative, or proxy (usually a family member), may give permission for the person to participate, particularly if the person’s durable power of attorney gives the proxy that authority. If possible, the person with Alzheimer’s should also agree to participate.
How Do Researchers Decide Who Will Participate?
Researchers carefully screen all volunteers to make sure they meet a study’s criteria.
After you consent, you will be screened by clinical staff to see if you meet the criteria to participate in the trial or if anything would exclude you. The screening may involve cognitive and physical tests.
Inclusion criteria for a trial might include age, stage of dementia, gender, genetic profile, family history, and whether or not you have a study partner who can accompany you to future visits. Exclusion criteria might include factors such as specific health conditions or medications that could interfere with the treatment being tested.
Many volunteers must be screened to find enough people for a study. Generally, you can participate in only one trial or study at a time. Different trials have different criteria, so being excluded from one trial does not necessarily mean exclusion from another.
What Can I Expect to Happen When a Clinical Trial or Study Ends?
The length of a clinical trial or study varies, depending on what is being studied. As a participant, you will be told how long the study is expected to last before you enroll.
After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and whether further testing is needed. After a phase I or II trial, the researchers conduct statistical analyses to evaluate the likelihood of success to decide whether to move on to the next phase or to stop testing the treatment or procedure because it was unsafe or not effective. When a phase III trial is completed, the researchers examine the information and decide whether the results indicate that the treatment or procedure was effective or not. They also look at side effects and whether the treatment was safe.
Research has expanded our understanding of Alzheimer’s disease and related dementias. To make further progress, research participants are urgently needed. It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When clinical trials include diverse participants, the study results may have a much wider applicability.
Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for these participants. Many older people have special health needs that are different from those of younger people. Having older adults enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people. Help advance research by volunteering for a clinical trial today!
What Can I Expect to Happen When a Clinical Trial or Study Ends Early?
Most clinical trials run as planned from beginning to end, but sometimes trials end before the expected end date for many reasons. Some reasons why a trial might be stopped early include:
- participants are experiencing unexpected and severe side effects
- there is clear evidence the harms of the treatment are greater than the benefits
- enough participants cannot be recruited
- there is clear evidence a new treatment or intervention is effective or beneficial
- the results of other trials are published that answer the research question or make it irrelevant
Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the federal government. Each clinical trial is designed to follow a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed. There are two monitoring sources that may stop a clinical trial early:
- An Institutional Review Board (IRB) at each study site must approve every clinical trial in the U.S. The IRB is made up of doctors, scientists, and lay people who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.
- Along with the IRB, most clinical trials are closely supervised by a Data and Safety Monitoring Committee.The committee is made up of medical experts who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, or even that it is working so well that they don’t need to continue, they will stop the trial early.
Sometimes Alzheimer’s disease studies are stopped early because researchers determine, by analyzing the data, that the potential benefits of continuing a study no longer outweigh the risks due to safety concerns, or a treatment proved to be ineffective. Once a trial is stopped early, all enrolled participants must be notified for practical and ethical reasons. However, when a trial is sponsored by a publicly traded company, it is required by law to quickly disclose this kind of information because it could affect those with financial interests in the company. This information is usually communicated through a press release or an announcement made at a press conference. Because of this law, trial participants may hear about a trial’s ending via the media and before study site researchers can inform them. Despite this, study coordinators will make every effort to let study participants know as quickly as possible.
If a Clinical Trial Ends, Will I Be Able to Continue Receiving the Study Drug?
While most clinical studies provide participants with access to medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. They do, however, monitor for known and potential side effects of the particular treatment in the study. Usually when a study ends, the drug or product that is being tested will not be available to you any longer until it has gone through some additional testing and approval. Sometimes study participants can stay on the study drug through an approach called an “open label extension” because then those people know that they are on the drug, as opposed to during the trial when they may be in the placebo or drug group and do not know which group they are in. This option can vary from study to study so you would need to discuss this with the researchers in charge of the study. Also, after the trial, there may be a waiting period before you can participate in another trial. One reason for this is to be sure that the original experimental drug is out of your system and would not influence the results of the next study.
How Can I Find Out Results from a Clinical Trial?
Results from clinical trials are usually published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. Results that are particularly important may be featured in the news and discussed at scientific meetings and by patient advocacy groups. Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the U.S. Food and Drug Administration (FDA) gives approval for the intervention to be tested in humans. Once a new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice. In many cases, if you participated in a blinded or masked study, which means participants don’t know who gets the treatment, the placebo, or another intervention, you will get information about the treatment you received. If something potentially dangerous to a participant is found, researchers are required to report that information as quickly as possible. During the informed consent process, ask when and how the results of the trial will be reported to you as a participant. Once the study ends, ask the research team members if the study results have been or will be published and ask them to share this information with you. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed database and the National Institutes of Health registry clinicaltrials.gov. If you prefer to discuss the study results with someone, contact NIA’s Alzheimer's disease and Related Dementias Education and Referral (ADEAR) Center at 1-800-438-4380 or the Alzheimer’s Association helpline at 1-800-272-3900.
For More Information About Lewy Body Dementia
NIA Alzheimer’s and related Dementias Education and Referral (ADEAR) Center
The National Institute on Aging’s ADEAR Center offers information and free print publications about Alzheimer’s disease and related dementias for families, caregivers, and health professionals. ADEAR Center staff answer telephone, email, and written requests and make referrals to local and national resources.
Explore the Alzheimers.gov portal for information and resources on Alzheimer’s and related dementias from across the federal government.
This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up to date.