• A clinical research trial (also called a clinical research study) is a study to see if an investigational medication or medical device is safe and effective for patients.
• In the United States, the Food and Drug Administration (FDA) is responsible for the review of data from clinical trials to determine whether an investigational product is safe and effective and could be made available to the public.
• All clinical research trials are monitored by ethical review boards, called Institutional Review Boards (IRBs), to protect the safety of all trial participants.
• Participation is voluntary.  You may leave a trial at any time, for any reason.
• There is no penalty or loss of benefits if you decide not to participate in a a trial or leave the trial at any time.

Alzheimer’s disease is one of the top ten causes of death in the United States and currently there is no definitive method of prevention or cure.  The Alzheimer’s Prevention Registry estimates that 80% of clinical trials are delayed because too few people volunteer to participate and that approximately 13.8 million people will have Alzheimer’s disease in 2050 if no new medical breakthroughs are discovered.  New treatments cannot be discovered without rigorous, randomized clinical trials and many more participants are needed.  Read more about why people consider participating in clinical trials from the Alzheimer’s Association.

1. Call our office at 512-407-8628 or complete our HIPAA-compliant online pre-screening form.
2. If you are interested in participating, you will be asked to go through a pre-screening process over the phone to determine if there is an ongoing study that might be a good match for you.  This involves a series of questions related to your health and the medications you take.  This may also include asking if you have a study partner.
3. If after the phone pre-screening it is determined that you may be eligible to participate in a clinical trial, the site staff will offer you a brief appointment in our office to discuss current clinical trials options available at that time.  Depending on the current COVID-19 restrictions in Austin, we may alternatively send you information about a specific trial to review at home.  We may schedule a phone call with you to review this information and answer questions.  We encourage you to include a family member or friend in these discussions if you choose.
4. If you decide that you would like to move forward with an initial screening visit for a specific study, the coordinator for that clinical trial will work with you to schedule a date and time that works best for you and your study partner.

Many of our studies require that a participant have a study partner. This person is sometimes referred to as a care partner.  The study partner’s role varies in different studies; however in general this person needs to be:

• Someone who knows you well and who you feel comfortable asking to participate in a clinical trial with you.
• A study partner can be a spouse, partner, child, other relative or good friend.
• The role a study partner plays in a clinical trial depends on the study. To ensure a potential study partner understands his or her role, he or she will be provided an informed consent form that provides details on what is expected of people in this role.

• If you are eligible to participate, you will be given an informed consent form that explains the trial and what will happen and when.  You will have all the time you need to review this information and we encourage you to share this information and discuss your participation with your family or others with whom you are close, as well as your healthcare providers.
• Before participating in a clinical trial, the study doctor or staff will answer any questions you may have about the study.  If you choose to participate, you will be asked to sign the informed consent form for the study.  If applicable, your study partner will also be asked to review and sign an informed consent form.
• Once you have signed the informed consent form, the study team will carry out some assessments to check that you and the study are a good fit.
• If this study is the right match for you, there will be study visits on a regular schedule.  This schedule varies based on each research study.
• If at any time you do not respond well or get worse, the study doctor will stop the study and you will receive treatment.

You have the right to:

• Informed consent:  This means all the information about the study will be explained to you and will have the opportunity to ask questions before you agree to participate in the study.  This also means that study staff will share any new information we receive about the study with you as soon as it is available.  When a person participates in a research study, we encourage them to share any questions or concerns throughout the study.
• Leave a clinical trial at any time for any reason.
• Some of the medical information that is collected during the trial, such as some medical tests.
• Know what other healthcare options are available for you if you choose not to participate in a study.

All medical and personal information collected during a clinical trial is confidential.  We will not share your information with anyone without your consent.

For more information about our ongoing clinical trials, please contact our office at 512-407-8628 or apply to join a clinical trial.