A longitudinal observational study of the HD-CAB (Huntington’s Disease Cognitive Assessment Battery) is necessary in order to support regulatory acceptance of the HD-CAB as a DDT. The longitudinal study will build on the previous collaborative work between CHDI and the StoutLab that resulted in the creation of the HD-CAB. Before the study can commence there are several Start Up Activities required that include preparation of documents for regulatory submissions and the development of a protocol and statistical analysis plan. In addition, substantial preparation for the regulatory meetings with the FDA and EMA is needed such as documentation of previous work, meeting request forms, summary documents, and other meeting materials.
|Short title||HD CAB Long Study|
|Effective start/end date||23/01/19 → 31/12/19|