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The HERO study is a clinical research study for adults with early symptoms of Alzheimer’s disease (AD). The HERO study is researching the safety of a study medicine called ION269, and whether it might prevent or delay the onset and/or progression of AD symptoms.Doctors and scientists are researching a new study medicine called ION269 for adults with Down syndrome who might get Alzheimer’s Disease. Alzheimer’s Disease is a brain disease that causes problems with thinking, learning, and remembering. We hope this study medicine will help people with Down syndrome not have problems with their memory as they get older.
By joining the HERO study, you can help scientists and doctors learn if the study medicine is safe and if it works the way we expect. This could help people who may develop AD in the future.
To join the HERO study, the study participant must have early symptoms of Alzheimer’s disease, and when applicable have a reliable study partner- this might be a spouse, sibling, or caregiver. The study partner must be above 21 years of age and have known the participant for more than six months.
*Other study requirements will apply
Participation in the HERO study lasts about 12 months. Study participants can expect the following:
Prior to receiving the study medicine or health checks, study participants must read and sign either the Informed Consent Form (ICF) or the Assent Form. If you sign the Assent Form, your legally authorized representative (LAR) must sign the ICF (if applicable). Your study partner will need to sign a separate Study Partner ICF if they are not your LAR.
Study Participants and their Study Partners visit the study clinic for health checks. Health checks include a physical exam, blood and urine samples, a heart test, brain imaging (painless), and puzzles to understand how the brain is working. These confirm if you qualify for the study.
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After the last Treatment Period visit, participants and study partners receive 2 more calls from the study doctor and complete 1 more visit to the study clinic for final health checks.
You lie still on a table inside a machine for about 30 minutes, as the machine takes pictures of your brain. This health check may be loud, but it does not hurt. You may be able to wear headphones, if available.
Just like the MRI, you lie still on a table inside a machine for about 30 minutes while the machine takes pictures of your brain. Before this test, the study doctor gives you an injection of radioactive dye in your arm. This helps the study doctor get better pictures of your brain. As with the MRI, you may be able to wear headphones (if available) during this health check, since it can be a bit loud.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Before you can have any study medicine or health checks, you must read and sign either the Informed Consent Form (ICF) or the Assent Form. If you sign the Assent Form, your legally authorized representative (LAR) must sign the ICF. Your study partner will need to sign a separate Study Partner ICF if they are not your LAR.
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures. This must be signed by the participant and/or their legally authorized representative, as appropriate. The Assent Form explains the same things but is shorter and easier to understand.
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Participants and their study partner will visit the study clinic for health checks.
Health checks include a physical exam, blood and urine samples, a heart test, pictures of organs
(does not hurt), and questionnaires.
Participants and their study partners visit the study clinic 9 times over 9 months. All visits include more health checks like those from the screening period.
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After the last Treatment Period visit, participants and study partners receive 2 more calls from the study doctor and complete 1 more visit to the study clinic for final health checks.
Participation in a clinical study is voluntary.
You can ask any questions you have and may leave the study at any time, for any reason.
Participation in HERO study lasts about 12 months. Study participants can expect the following:
The study medicine, called ION269, is designed to help the body to produce less amyloid plaque (a sticky protein that damages the brain and is linked to Alzheimer’s Disease) If the study medicine works as intended, doctors hope that it may prevent or delay the onset and/or progression of AD symptoms.
Yes, all participants in the HERO study will receive the study medicine.
ION269 is an investigational study medicine. This means doctors are studying it to find out if it is safe and if it works. It is not approved by regulatory agencies like the U.S. Food and Drug Administration or European Medicines Agency. It can only be used in clinical research studies like the HERO study.
Alzheimer’s disease (AD) is one of the most common brain diseases in the world. You are not alone. Although there is currently no cure for AD, doctors and scientists are working hard to develop medicines that may help to treat or even prevent AD.
As you may know, AD gradually causes problems with thinking, learning, and remembering. These symptoms increase over time, although the speed of progression can vary a lot between people.
Scientists do not know exactly what causes AD, but one factor that seems to play a role is having lots of amyloid plaque in the brain. Amyloid plaque is a sticky protein that damages the brain. Scientists want to develop medicines that help the body produce less amyloid plaque. They hope this may help prevent, slow down, or even stop AD symptoms.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Research studies are important because they help us get new medicines. Before a new medicine can be prescribed, doctors and scientists must study it during research studies. This can only happen if people like you volunteer to become participants. Without study participants, we cannot have new medicines.
It is always your choice whether to join a research study. And if you join a research study, you can leave whenever you want.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study including its goals, duration, benefits, risks, tests and procedures. This must be signed by you and/or your Legal Authorized Representative (LAR), as appropriate.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you participating in the HERO Study. Contact the study clinic to learn more, or take the pre-screener to see if you or a loved one may qualify.
