Enroll-HD is a worldwide observational study for Huntington’s disease families. It will monitor how the disease appears and changes over time in different people, and is open to people who either have HD or are at-risk. Enroll-HD is up and running for HD families in North America, Europe, Latin America, Australia, New Zealand and some countries in Asia. It will eventually include more than 20,000 people. Monitoring people over time in a real-world setting contributes to scientific knowledge. The study is designed to accelerate the discovery and development of new therapeutics for HD.The study builds upon and unites two successful studies: COHORT in North America and Australia, and REGISTRY in Europe.
Enroll-HD will help accelerate research by:
- Collecting standardized data, in the same way and using the same methods, from tens of thousands of people around the world. More people undergoing the exact same evaluations means the study is more likely to uncover new things about HD.
- Making data available to any scientist with a legitimate research project who wants to better understand HD. We want as many scientists as possible all around the world working on HD.
- Developing a comprehensive database of people who may be interested in volunteering for future studies, including drug trials, with all the necessary information about them already in place.
Who can participate?
Any member of a family affected by HD can take part, including:
- Individuals who know they carry the expanded gene, whether or not they show signs and symptoms of the disease
- Individuals who are at risk of developing the disease (but have not undergone genetic testing)
- Individuals who have a family history of HD but know they do not carry the expanded gene
- Spouses/partners (not blood related) of family members with HD.
Children under the age of 18 with clinically diagnosed juvenile HD may participate with the consent of a parent or legal guardian.
How long will the study last?
Enroll-HD is an open-ended study, which means it has no defined end time, but you can leave at any time you choose. You will attend one study visit each year.
What will happen during study visits?
During each study visit, you will undergo a series of movement and behavioral tests. Functional tests will be given to determine how well you perform tasks on your own. You will also answer questions to help the study team evaluate your emotional state and quality of life. Additionally, if you wish, you can choose to donate a small volume of blood at each visit to help the study team:
- Understand why and when certain symptoms appear
- Identify possible ways to devleop new, effective drugs.
What safeguards are in place for study participants?
To protect your privacy, your name, address, phone number and other information that identifies you will not be shared with anyone outside of the local study coordinators. To ensure your safety and confidentiality, there are strict regulations governing the conduct of clinical studies, including observational studies. This includes de-identification of the data and samples you may contribute by using a special coding process.
During a process called informed consent, you will receive all the facts regarding study participation prior to enrollment. If you decide to participate, you will sign an informed consent document. This document is not binding and you can leave at any time, for any reason at all. You may be asked to undergo a final safety assessment before leaving the study.
We encourage you to talk with your family before participatingin this, or any other, study. You may want family members to accompany you to study visits or provide other assistance during your participation. Getting their support in advance may be essential.
Where can I get more information about Enroll-HD?
Contact your healthcare profesional or visit www.enroll-hd.org.
Who do I contact in Western Australia to find out about Enroll?
The Principal Investigator for the Western Australian site is Rachel Zombor. For more information please phone the Neurosciences Unit on 08 9347 6464 or email Neurosciences.ResearchScientist@health.wa.gov.au.