HDClarity Study Collecting Cerebrospinal Fluid and Blood Samples to Support New Treatments for Huntingtons Disease

What this Trial Is About

Researchers are conducting a long-term observational study called HDClarity to collect cerebrospinal fluid CSF and plasma samples from at least 2,500 participants at various stages of Huntingtons disease HD. The main goal is to gather high-quality CSF samples to study biomarkers and disease pathways that may help develop new treatments for HD. Additionally, plasma samples will be collected to support biomarker research relevant to HD. Participants attend two annual visits a Screening Visit and a Sampling Visit. The Screening Visit involves collecting medical history and clinical data. Those eligible and willing continue to the Sampling Visit, where blood is drawn via venipuncture and CSF is collected through lumbar puncture after fasting for at least six hours or overnight. Some participants may also attend an optional Repeat Sampling Visit 4-8 weeks after the first Sampling Visit during their first year of enrollment. Annual visits continue regularly with a two-month window. Throughout the study, participants health and clinical status are monitored, with the option to skip visits without leaving the study. If a participant misses Sampling Visits for three consecutive years, they may be discontinued but can re-enroll later with consent. The study collects detailed clinical and phenotypic data alongside biological samples to evaluate biomarkers and pathways related to HD, supporting therapeutic development. The study is open-ended and ongoing.

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease