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The HERO study is a clinical trial for people with Down syndrome who are between 35 and 55 years old.
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.
Participating in the HERO study could improve our understanding of how to help individuals with Down syndrome in the future.
To join the HERO study, the study participant must be between 35 and 55 and diagnosed with Down syndrome (DS). They must also have a reliable study partner- this might be a parent, sibling, or caregiver. The study partner must be above 21 years of age and have known the participant for more than six months.
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*Other study requirements will apply
Participation in the HERO study lasts about 12 months. Study participants can expect the following:
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.
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, MRI and PET scans (machines that take pictures of the brain- does not hurt), and questionnaires.
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Participants and their study partners visit the study clinic about 10 times. All visits include more health checks like those from the screening period.
Over the duration of the treatment period, participants will undergo 4 injections in the lower back. The study medicine will be injected during the first lumbar puncture only. Participants may get medication to stay comfortable during the lumbar puncture.
In between visits, the study doctor calls the participants and study partners via phone to ask questions about how you are doing.
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.
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 HERO study is researching whether the new study medicine, called ION269, is safe and works the way it is expected. The study medicine is a liquid that will be injected into the lower back once during the study. Additional medication may be available to help the participant relax and stay still during the lumbar puncture.
After the study medicine gets injected, it travels to the brain where it tries to tell the brain to create less amyloid beta. Amyloid beta is a substance that can hurt the brain. Many adults with DS produce lots of amyloid beta.
The investigational study medicine hopes to protect the brain by telling it to produce less amyloid beta and potentially help people with Down syndrome one day by slowing down or preventing the development of Alzheimer’s Disease.
Yes, all participants in the HERO study will receive the study medicine.
Investigational means the study medicine is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or any other regulatory agency, and it can only be used in clinical research studies like the HERO study.
Down syndrome is a genetic condition that happens when a person is born with an extra chromosome, specifically chromosome number 21. Chromosomes are tiny structures inside the cells of the body. They carry information on how your body forms and functions. Having an extra chromosome can affect how a person looks and thinks, but it is not a disease.
Even though Down syndrome is not a disease, it can increase the risk of a common disease called Alzheimer’s Disease.
Alzheimer’s Disease is a brain disease. It has no symptoms at first, but eventually it causes problems with thinking, learning, and remembering. The risk of developing Alzheimer’s Disease is associated with increasing age. The average age for developing Alzheimer’s Disease for adults with Down syndrome is in their early 50’s.
People with DS have >90% lifetime risk of developing Alzheimer’s Disease, and most exhibit signs of AD by 40 years of age.
Scientists think that the increased risk of AD — like other health issues associated with Down syndrome — results from the extra genes present.1 Chromosome 21 plays a key role in the relationship between Down syndrome and Alzheimer’s Disease as it carries a gene that produces one of the key proteins, amyloid protein, involved with changes in the brain associated with Alzheimer’s. The build-up of amyloid protein in the brain disrupts the way brain cells communicate with each other. Amyloid accumulation is seen in almost all adults over 40 with Down syndrome. Despite these brain changes, not everyone with Down syndrome develops Alzheimer’s symptoms.2
This study aims to delay or prevent the onset of AD in people with Down syndrome.
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.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
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. Contact the study clinic to learn more.
