Published by: Alzheimers.gov
Thanks to the thousands of people who have participated in research studies, scientists have made great progress in understanding Alzheimer’s disease and related dementias. Major advances would not be possible without the participation of many diverse participants, including people with dementia, caregivers, and healthy volunteers. Learn more about clinical research and how you could help discover new ways to treat and prevent Alzheimer’s and related dementias.
What Are Clinical Research Studies?
Clinical research is medical research that involves people. The overarching goal of clinical research is to develop knowledge that improves human health or increases the understanding of human biology. There are two types of clinical research studies: observational studies and clinical trials.
Researchers use observational studies to collect information from people and compare that data over time. For example, researchers may use medical exam data, interviews or assessments, or online survey data to learn about how different behaviors or lifestyles relate to health and disease or to understand how a disease progresses over time. Observational studies may help researchers identify new treatments or prevention strategies to test in clinical trials.
Clinical trials are a type of research that tests new drugs, medical devices, surgical procedures, or behavior and lifestyle changes such as exercise. Clinical trials may also test ways to detect and diagnose diseases and to better care for those living with diseases. Researchers determine if what is being tested, called an intervention, is safe and effective by comparing results in the test group to those in the control group.
Before conducting clinical trials in people, researchers first test the intervention for safety, effectiveness, and potential problems in laboratories. Researchers also must submit their study to an Institutional Review Board (IRB), which is a group of experts who review and monitor studies to ensure participants’ safety. If the intervention is approved for testing in people, the trials move through phases, starting with a small group of volunteers before increasing the number of study participants. This helps to ensure the treatments are safe and effective for a broader population.
Why Participate in a Clinical Research Study?
By joining a study or trial, you become a partner in helping researchers discover new ways to potentially diagnose, treat, and prevent Alzheimer’s and related dementias. You may also:
- Receive medical care and new treatments that are not yet available otherwise
- Learn about the disease and your medical condition
- Gain access to resources, such as educational materials and support groups
- Help provide others with better treatments and prevention strategies in the future
Who Can Participate?
Nearly everyone! Anyone who is age 18 or older can choose to participate in research studies. To produce meaningful results, Alzheimer’s and related dementias researchers need a variety of volunteers, including:
- People who are healthy, without symptoms of dementia
- Both younger and older people
- People diagnosed with Alzheimer’s or a related dementia, such as Lewy body dementia, vascular dementia, or frontotemporal dementia
- People who are identified as at-risk given their family history, genetic makeup, or biomarkers, which are measures that could signal very early stages of disease
- People with Down syndrome, who are at higher risk for Alzheimer’s disease
- Caregivers of people with dementia
- People from diverse and underrepresented groups, such as those who are Asian, Black/African American, Hispanic/Latino, Native American, and/or Pacific Islander
Researchers need participants who represent all types of races and ethnicities, genders, geographic locations, and sexual orientations. Having diverse people in studies can help researchers understand how dementia affects certain groups, why some communities are disproportionately affected by certain dementias, and which interventions may be most effective in particular groups. Ultimately, it’s unlikely there will be just one treatment for Alzheimer’s disease, rather, the approach will be a combination of treatments customized to each individual. Learn more about the research areas the federal government and others are exploring.
Frequently Asked Questions About Clinical Research Studies
Many people like the idea of participating in clinical research studies but are reluctant to join a trial due to misinformation or past clinical trial history. Learn more about the facts of clinical research.
Q: What steps are taken to keep volunteers safe?
A: Researchers are required by law to ensure the safety of study participants. There is never any obligation to participate in a study and being part of a study may include risks. Risks can include side effects of the treatment, the treatment not working, or the treatment being uncomfortable. However, the following steps help keep all volunteers safe:
Federal law requires researchers to tell you about any known risks. You have the right to ask questions about the trial. Not all side effects of a treatment or prevention are predictable. However, researchers and IRBs do their best to make sure that they minimize risk, including the risk of pain, to participants.
An IRB of doctors, scientists, and people from the general public reviews all studies before they begin to make sure they are safe and necessary. Throughout the course of the study, the IRB regularly reviews each study and its results to make sure safety plans are followed.
Additionally, many clinical trials are supervised by a Data and Safety Monitoring Committee. These experts monitor study results and stop a trial early if treatment is not working.
Q: How do researchers decide who participates?
A: Researchers use a careful screening process to recruit participants. All studies have rules (inclusion and exclusion criteria such as age, other health conditions, medications, and location) that outline who can participate.
Q: Does the research team keep my identity private?
A: Researchers must keep health and personal information private, as outlined by federal laws. Most studies only share results that are de-identified, or not linked to specific individuals. Some studies may share de-identified data with other qualified researchers to use in their investigations. Talk with the study coordinator to find out what information may be shared and how.
Q: Does it cost money to join a clinical trial?
A: Most clinical trials do not involve any costs for the participant. Some trials offer participants a stipend, or payment, for participation. Some trials may even pay for travel, lodging, and other expenses associated with participating in the study. However, other trials may not cover these expenses and may require study participants to travel to the study site several times at their own expense.
Q: If I join a study, will I get the investigational treatment?
A: In many studies, not all participants will receive the new treatment. Often, some participants will receive a placebo. A placebo is an inactive substance that looks like the drug or treatment being tested. Participants will not know whether they receive the new treatment or the placebo. This is done so researchers can judge whether or not the new treatment has an effect. In some cases, the researchers and study personnel are also unaware of who is in which treatment group. In a study that includes placebos, all participants receive the same standard of medical care and are important in helping to test the treatment.
Q: If I join a trial and change my mind, can I withdraw from the study?
A: Participation in a clinical research study is 100% voluntary. You can quit a study at any time, for any reason, without penalty.
Q: Why do some studies stop early?
A: Sometimes researchers stop studies early. However, even when the studies stop early, they provide researchers with valuable information. Studies may be paused or stopped for a number of reasons:
- Because new information becomes available to researchers
- Due to safety concerns
- If the goals of the study are met early or by another research team
- If a treatment is found to be ineffective or to cause unexpected and serious side effects
Q: Do participants receive information about the study results?
A: Researchers will collect and analyze data, and then decide what steps to take next. This may include sharing individual health information and test results with the participant. Often, the collective study results are published in research journals. This is so other researchers, health care professionals, and the public can look at them. Published results are valuable. They give other researchers information that can help their own work move forward. Before a study begins, you will receive information about:
- The study’s length
- Whether you will continue to receive treatment after the study ends (if applicable)
- How you will be kept informed about study results
- How To Find a Clinical Trial
If you are interested in participating in an Alzheimer’s or related dementia clinical study, there are tools to help you get started.
Clinical Trials Finder
The Alzheimers.gov Clinical Trials Finder is an easy-to-use resource for people who want to participate in Alzheimer’s and related dementias research. By searching the database, you can learn more about specific research studies, review the enrollment criteria, and reach out to study coordinators to ask questions. Even if there isn’t a study happening near you, you may still be able to participate in a study online.
Registries and Matching Services
Studies might not be available in the right place or at the right time for you. However, you can make yourself available to many local and national studies by joining a registry or matching service. When you sign up for a registry, researchers can then contact you and invite you to volunteer in specific research studies. You may be invited to different types of studies, including surveys, interview studies, and medication trials.
Alzheimer’s Disease Research Centers
Another great way to get started is to connect with an Alzheimer’s Disease Research Center near you. These centers are located across the United States and conduct clinical trials as well as observational studies of dementia and memory and aging.
The ADEAR Center
Do you have questions about participating in Alzheimer’s and related dementias clinical research studies? Contact the NIA Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email for more information or help to find a clinical trial.