Huntington Study Group (HSG) clinical research studies that are
currently enrolling eligible research participants:
2CARE
COHORT
HART
PREDICT-HD
European clinical research studies that are
currently enrolling eligible research participants:
REGISTRY
2CARE: Coenzyme Q10 in Huntington’s Disease
The Huntington Study Group (HSG), under the direction of Merit Cudkowicz MD, MSc (Massachusetts General Hospital), Michael McDermott PhD and Karl Kieburtz MD MPH (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of coenzyme Q10 (CoQ) in individuals with Huntington’s disease (HD) to assess the effects of CoQ on the progression of functional decline in HD, as well as the long-term safety and tolerability at the dosage studied. Coenzyme Q10, a naturally occurring substance in the body, is available for purchase over the counter as a nutritional supplement. CoQ is being studied as an investigational drug at a higher dosage than is currently available for purchase.
CoQ has been used to treat a variety of human disorders, including those involving the heart and circulatory system, cancer, muscular dystrophy, a muscle coordination disorder called ataxia, and other disorders. The most marked results seem to have occurred in patients with a preexisting inherited deficiency of CoQ, although the studies reporting this information are limited by their not being controlled clinical trials. However, no serious safety issues have been reported. Recent preliminary studies of CoQ in neurologic disorders such as Parkinson’s disease, Amyotrophic Lateral Sclerosis, and Huntington’s disease confirm the safety and tolerability of CoQ in daily dosages up to, including, and exceeding the dosage planned for the 2CARE study when used for a short time.
The 2CARE study will be the largest therapeutic clinical trial to date in Huntington’s disease. Six hundred eight research participants will be enrolled at approximately forty-six clinical sites in the US, Canada, and Australia.
Please see the 2CARE Participating Site List. Please check back often. New sites will be added to this list as they secure the approval required to enroll study participants.
COHORT: Cooperative Huntington’s Observational Research Trial
This long-term observational study will initially take place at 40 North American and Australian Huntington Study Group (HSG) sites. The goal of COHORT is to collect information in order to learn more about HD, potential treatments, and to plan future research studies of experimental drugs aimed at postponing the onset or slowing the progression of HD. This study will recruit both adults and children who have clinically diagnosed HD and adults who are a part of an HD family. Individuals who choose to participate will have one study visit every year for as long as they are able and choose to participate. Please refer to the COHORT Participating Site List for sites in your area.
At each annual visit, all individuals participating in COHORT will be required to have a clinical evaluation. Those who are 18 years of age and older will have blood drawn for genetic testing of the CAG polymorphism and for other genetic changes, which may be important to Huntington’s disease. For those who are 18 years of age and older, there will be optional research procedures including the collection of family history and the collection and storage of blood and urine for future HD research.
Data from the COHORT study will be collected in databases designed to protect the privacy of all those who participate. The data and samples will provide researchers with a valuable resource to address a wide variety of research questions in Huntington’s disease.
To read more about the different aspects of the COHORT study, click the appropriate link:
Clinical Evaluation
Collection of Blood for Genetic Testing
Collection of Family History Information
Collection and Storage of Biological Samples for Future HD Research
Clinical Evaluation
Each year COHORT participants will undergo a medical and neurological evaluation. This evaluation will include standardized assessments of movement, thinking, memory, ability to perform daily activities, and behavior. Also, a medical and neurological examination will be conducted and the participant will provide information about medical history and current medications.
Collection of Blood for Genetic Testing
At the initial visit, all COHORT participants who are 18 years of age and older will have blood drawn for genetic testing of the CAG polymorphism and for other genetic changes, which may be important to Huntington’s disease. Since this testing will be experimental, neither the COHORT participants nor the site investigators will receive the results of this testing.
Collection of Family History Information (optional)
Family history data will be used to learn more about the natural history of the disease over several generations. This information may uncover new details about why there are differences in how HD affects different families and different members within a family. Any COHORT participant 18 years of age and older with a family history of HD will be asked to participate. This part of the COHORT study is optional. If the participant chooses not to provide family history information, he or she may still take part in the COHORT study.
The participant will be asked to complete a Family History Questionnaire (FHQ), which asks questions about the participant’s extended family, including:
• Family members’ names, birthdates, sex, and, if applicable, date of death
• For any affected family members, age of HD diagnosis and whether a physician made the diagnosis will be collected.
Collection and Storage of Biological Samples for Future HD Research (optional)
Scientists have found that blood, urine, and other biological samples contain clues about HD that may be used to better understand the progression of the disease and to develop new therapies. Any COHORT participant 18 years of age and older will be given the option of having blood and urine collected and stored for future HD research. If a participant chooses not to participate, he or she may still take part in the COHORT study. These samples will be labeled with a unique identification code and stored in a research facility.
These stored samples will provide researchers with the resources necessary to study Huntington’s disease. Huntington’s disease researchers from institutions all over the world will be able to request samples for research in HD. All samples will be identified with a code, and researchers will not receive any personally identifying information about COHORT participants.
HART: A Multi-Center, North American, Randomized, Double-Blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease
The Huntington Study Group (HSG) is conducting a study of the research medication ACR16 in persons 30 years of age and older who have clinical features of Huntington Disease (HD). HART is designed to determine the general safety and tolerability and an effective dose of ACR16 as well as the effect of ACR16 on motor (movement) and cognitive (thinking) abilities in subjects with HD. Approximately 35 research centers in North America will enroll up to 220 subjects for 16 weeks each. Enrollment began in October 2008. This study is sponsored by NeuroSearch Sweden AB.
Please see the HART Participating Site List. Please check back often. New sites will be added to this list as they secure the approval required to enroll study participants.
More information can be found in the HART Press Release, Dr. Marsha Miller's February 2009 article and Dr. LaVonne Goodman's February 2009 article. Thank you.
PREDICT-HD: Neurobiological Predictors of Huntington's 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.
As of April 14, 2008, the PREDICT-HD study has 1011 participants who dedicate time from their busy lives to contribute to the study—nearing the anticipated enrollment figure of 925! In order to reach this goal, the study is seeking additional gene negative participants to enroll in this important project. Below we have included an additional study description along with contact information about how to become one of our valuable participants.
The PREDICT-HD study uses 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 is 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.
If you are interested in learning more about this study, please contact the Huntington Study Group toll free at . For a participating site near you, please go to the PREDICT-HD Participating Site List.
For information about PREDICT-HD found on the ClinicalTrials.gov web site, please go to PREDICT-HD.