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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:

Why would I participate in a clinical trial?

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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 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 resources

Research has expanded our understanding of Alzheimer’s and related dementias. This progress is largely thanks to the people who have volunteered for clinical trials. To make further progress, research participants are urgently needed. Because the health needs of older people are often different from those of younger people, researchers need older adults to participate in their studies. That way, scientists can learn how new drugs, therapies, medical devices, surgical procedures, or tests will work for people in this age group.

To learn more, watch these other NIA videos of clinical-trials participants telling their stories.

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 NIA Alzheimer’s and related Dementias Education and Referral (ADEAR) Center by calling 800-438-4380 or emailing adear@nia.nih.gov. 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 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 happens at the end of a clinical trial or study?

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.

What can I expect if 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. Some reasons why a trial might be stopped early include:

  • The treatment or intervention being studied is clearly more effective or beneficial than existing ones.
  • Participants are experiencing unexpected and severe side effects.
  • The harms of the treatment or intervention are clearly greater than the benefits.
  • The treatment or intervention is unlikely to have a meaningful effect even if the study continues.
  • Not enough participants can be recruited.
  • 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 United States. The IRB is made up of doctors, scientists, and laypeople 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.

If 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, the company is required by law to disclose this kind of information quickly 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 on the news or on social media before study site researchers can inform them personally. Despite this, study coordinators make every effort to let study participants know as quickly as possible, and they are available to answer participants’ questions and let them know what may happen next.

Patient advocacy organizations can also provide support and information when clinical trials end early. The NIA ADEAR Center is another source of information. Call 800-438-4380 or email adear@nia.nih.gov.

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. Usually when a study ends, the drug or product that is being tested will not be available to participants until it has gone through additional testing and approval.

In some cases, study participants can stay on the study drug through an approach called an “open label extension.” In this type of study, participants who were part of a randomized controlled trial are invited to continue taking the drug after the initial study ends. This option varies from study to study, so you would need to discuss it with the researchers in charge of the study.

After the clinical trial, there may be a waiting period before you can participate in another trial. One reason for this waiting period 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?

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. 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.

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 the NIA ADEAR Center at 800-438-4380 or the Alzheimer’s Association helpline at 800-272-3900.

For more information about Alzheimer’s disease research

NIA Alzheimer’s and related Dementias Education and Referral (ADEAR) Center
800-438-4380
adear@nia.nih.gov
www.nia.nih.gov/alzheimers
The NIA ADEAR Center offers information and free print publications about Alzheimer’s 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.

Alzheimers.gov
www.alzheimers.gov
Explore the Alzheimers.gov portal for information and resources on Alzheimer’s and related dementias from across the federal government.

ClinicalTrials.gov
www.clinicaltrials.gov 

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.

nia.nih.gov

An official website of the National Institutes of Health