COHORT

Cooperative Huntington’s Observational Research Trial (COHORT)

This long-term observational study currently involves 43 North American and Australian HSG sites. The goal of COHORT is to collect clinical information to learn more about the natural history of HD and to correlate these findings with the genetic and hereditary information that are obtained from the analysis of blood DNA and family history patterns. This knowledge will contribute to a better understanding of potential treatments, and will assist in the planning of future research studies of experimental drugs aimed at postponing the onset or slowing the progression of HD. COHORT is recruiting both adults and children who have clinically diagnosed HD. In addition, the study is also recruiting any 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, or to the 2008 Huntington Disease Clinical Research Symposium COHORT Abstract and Poster, 2008 COHORT Brochure, COHORT Community Spring 2008 Newsletter, 2008 COHORT Fact Sheet and 2005 Press Release for more information.

At each annual visit, individuals participating in COHORT will undergo a clinical evaluation. Those who are 18 years of age and older will have a blood sample drawn for DNA analyses that may be important to Huntington’s disease. For those who are 18 years of age and older, there will be optional research procedures which include the collection of family history information and/or the collection and storage of blood and urine for future HD research.

Data from the COHORT study will be collected in databases that are securely maintained, with an emphasis on protecting 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.

There are four different aspects of the COHORT study...

1. Clinical Evaluation

Each year, COHORT participants undergo a medical and neurological evaluation. This evaluation includes standardized assessments of movement, thinking, memory, daily activities, and behavior. Also, a medical and neurological examination will be conducted and the participant will be asked to provide information about medical history and current medications.

2. Collection of Blood for DNA Analysis

At the initial visit, COHORT participants who are 18 years of age and older will have a blood sample drawn for genetic analysis of the HD gene and of other possibly related genetic variations. Since this analysis is experimental, neither the COHORT participants nor the site investigators will receive the results of these research analyses.

3. Collection of Family History Information (optional)

Family history patterns will be collected to learn more about the natural history of HD 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 information regarding whether a physician made the diagnosis will be collected.

4. 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. COHORT participants 18 years of age and older will be given the option of having blood and urine collected and stored for future HD-related 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 code, which does not include any personal information, and stored in a research facility.

These stored samples will provide researchers with the material necessary to study HD. Qualified researchers will be able to request samples for investigation of processes that cause or contribute to HD. All samples will be identified with a code, and researchers will not receive any personally identifying information about COHORT participants.