Creatine Safety and Tolerability in Premanifest HD: PRECREST
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
PRECREST is a two phase protocol for Huntington's disease in which 60 premanifest and at-risk
subjects will first be randomized into a double blind placebo controlled dose titration study
bringing them to 30 grams daily or their highest tolerated dose. This phase will establish
the highest tolerable doses in premanifest HD and permit the detection of toxicity and
intolerability with attribution to active compound versus placebo, and enable a dose response
assessment of biomarkers. In the second phase, all subjects will enter a year long open-label
treatment on 30 grams daily (or their highest dose) of creatine to assess long term exposure
to high dose creatine and its long term impact on various biomarkers.