Potential endpoints for clinical trials in premanifest and early Huntington's disease in the TRACK-HD study: analysis of 24 month observational data

Sarah J Tabrizi, Ralph Reilmann, Raymond A C Roos, Alexandra Durr, B R Leavitt, Gail N Owen, Rebecca Jones, Hans Johnson, David O Craufurd, Stephen L Hicks, Christopher Kennard, Bernhard Landwehrmeyer, Julie C Stout, Beth Borowsky, Rachael I Scahill, Chris Frost, Douglas R Langbehn

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Abstract

TRACK-HD is a prospective observational biomarker study in premanifest and early Huntington?s disease (HD). In this report we de? ne a battery of potential outcome measures for therapeutic trials. We assessed longitudinal data collected at baseline, 12 months, and 24 months at sites in Leiden (Netherlands), London (UK), Paris (France), and Vancouver (Canada). Participants were individuals without HD but carrying the mutant HTT gene (ie, premanifest HD), patients with early HD, and healthy control individuals matched by age and sex to the combined HD groups. Data were collected with 3T MRI, clinical, cognitive, quantitative motor, oculomotor, and neuropsychiatric assessments. We estimated adjusted, between-group di?erences in rates of change in these measures and concomitant longitudinal e?ect sizes.
Original languageEnglish
Pages (from-to)42 - 53
Number of pages12
JournalThe Lancet Neurology
Volume11
Issue number1
DOIs
Publication statusPublished - 2012

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