Creatine Safety, Tolerability, & Efficacy in Huntington’s Disease
The Huntington Study Group (HSG), in a partnership between Massachusetts General Hospital (MGH) and the University of Rochester, is conducting a global, multi-center, randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older with Huntington’s Disease (HD).
CREST-E is designed to assess the potential of high-dose pharmaceutical grade creatine to slow the progressive functional decline that occurs in HD, to examine the long-term safety and tolerability of creatine, and to assess potential changes in the body and brain due to creatine.
Creatine has been shown to reduce brain shrinkage and to extend survival in transgenic mouse models of HD and to reduce oxidative stress markers in blood and brain. In a preliminary clinical study in individuals with HD, creatine has been shown to be safe, tolerable, bioavailable in brain, and to reduce serum 8OHD'dG (an indicator od oxidative injury to DNA). Unlike what is available for purchase over the counter as a nutritional supplement, the creatine in CREST-E is pharmaceutical grade. The high-doses being studied in this study have not been used before and so monitoring its safety at study visits is an important aspect of the study, even though many people take creatine at lower doses.
The CREST-E study is currently enrolling subjects. Approximately 60 clinical sites globally will enroll up to 650 research participants for 37-months of follow-up.
Please see the CREST-E Participating Site List for a center near you and check often for updates. New sites will be added to this list as they secure the approval to enroll study participants.
For more information call the Huntington Study Group toll-free number at 1-800-487-7671.
This study is sponsored by the National Institutes of Health (NIH)/National Center for Complementary and Alternative Medicine (NCCAM) and the U.S. Food and Drug Administration (FDA) Orphan Products division.
Click here to listen to Part I of Dr. Steven Hersch, MD, PhD, talk about the CREST-E study on Help 4 HD blog talk radio
Click here to listen to Dr. Giovanni Schifitto, Part II of the CREST-E series on the Help 4 HD blog talk radio!
CREST-E Participating Site List
CREST-E Brochure 2013
last updated: October 2013