Neurobiological Predictors of Huntington Disease
Individuals Encouraged to Enroll
In September 2001, the Huntington Study Group, under the direction of Jane Paulsen, Principal Investigator (University of Iowa), received funding from the National Institutes of Health (NIH) to study healthy persons who are known to have the CAG expansion in the HD gene.
The initial PREDICT-HD study used a variety of tests to examine the nature and pattern of neurobiological changes and neurobehavioral changes that occur in the period leading up to a diagnosis of HD. The intent of the study was to learn more about the beginning changes in thinking skills, emotional regulation, brain structure and brain function as a person begins the transition from health to HD. With the dedication of 1,000+ participants, we completed our initial goals for the study in 2008. At that time, the National Institutes of Health decided to continue the research for at least five more years (which we have named PREDICT-HD 2.0).
Why is PREDICT-HD 2.0 studying people at risk for Huntington disease?
The ultimate goal of the PREDICT-HD 2.0 study is to define the earliest biological and clinical features of HD before at-risk individuals have diagnosable symptoms of the disease. Completion of this research will make it possible to test possible treatments to delay or prevent the onset of HD. It is a study that is expected to give us essential information to help design future studies of experimental drugs aimed at slowing or postponing the onset of HD in healthy persons at risk for developing HD. As possible drugs are developed, individuals will be invited to participate with separate consents and protocols.
Who is eligible to participate in PREDICT-HD?
• Gene negative and gene positive individuals: specifically, men and women at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD (CAG > or equal to 36 for CAG-expanded group or CAG < 36 for CAG-norm group).
• 18 years of age or older
• Able to commit to a minimum of 5 yearly evaluations
• Commitment of a companion to attend visits or complete surveys via mail
•Able to undergo a MRI
What can I expect at a PREDICT-HD 2.0 visit?
The PREDICT-HD study uses a variety of tests to help examine the nature and pattern of brain changes that occur in the period leading up to an HD diagnosis. Changes in thinking skills, emotional regulation, brain structure and brain function are measured through computer tasks, paper and pencil tests, motor examinations, survey questions, yearly blood samples and MRI scans.
What if I do not want anyone to know I am at risk for HD? How will my privacy be protected?
Privacy is a central concern in PREDICT-HD, and we have designed the study to protect the confidentiality of research participants to the fullest extent possible. Names will not appear on the study forms - instead, a code number will be assigned to identify research participants. A code (different from the participant code) will be used to identify blood samples and DNA results.
I want to help HD research, but would prefer not to learn whether I am developing signs of HD. Is it possible to still participate?
Yes. Participants will not be told if they are developing signs of HD. If participants decide they do want to know this information, they will need to arrange for an evaluation outside of the PREDICT-HD study visits.
Are there any risks to me as a participant in PREDICT-HD?
Uncertainties of not knowing when HD will start may cause distress. There are some minor risks when blood is drawn for the blood sample. These risks are further explained in the consent form, and the research investigator can answer any questions.
What is the benefit to me of participating in PREDICT-HD?
There is no direct health benefit from participating in PREDICT-HD. However, participation may help to provide important information useful for understanding the onset of HD in persons at risk for the illness.
How do I get more information about participating in the PREDICT-HD Study?
If you are interested in learning more about this study, please contact the Huntington Study Group toll free at 800-487-7671.
For a participating site near you, please go to the PREDICT-HD Participating Site List.
PREDICT-HD Participating Site List
PREDICT Brochure April 2010
PREDICT Brochure June 2009
Huntington Project Research Spotlight 'Predictors of HD' article, January 2008
Huntington Project Research Spotlight report 'Review of Published Article-Preparing for Preventive Clinical Trials: The PREDICT-HD Study-', June 2007
last updated: March 2011