CREST-E Huntington’s Disease Study
The Huntington Study Group (HSG) and Massachusetts General Hospital (Steven M. Hersch, MD, PhD) are conducting a Phase 3 randomized, double-blind, placebo-controlled clinical trial in Huntington's disease (HD). Approximately 50 clinical sites globally will enroll up to 650 research subjects. Kathleen Shannon, MD, is conducting the study at Rush University Medical Center.
The CREST-E study is designed to assess the effects of high-dose creatine to slow the progressive of 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. Additionally, this research will evaluate how a variety of biological processes are affected by the study drug or how they may reflect disease activity or progression
Creatine has been shown to reduce brain shrinkage and to extend survival in HD mouse models and to reduce oxidative stress markers in blood and brain. Creatine used in CREST-E is in a highly purified form considered pharmaceutical grade. The high doses being studied in this study have not been used before, so monitoring its safety at study visits is an important aspect of the study, even though many people take creatine at lower doses.
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Are able to provide written informed consent.
- Have clinical features of HD and a confirmation by family history or genetic testing.
- Are willing to comply with the study procedures.
- Are not pregnant, lactating or intending to become pregnant.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of known sensitivity or intolerability to creatine monohydrate.
- Have had exposure to any investigational drug within 30 days of randomization (baseline visit).
- Use supplemental creatine at a dose greater than 10 grams/day within 90 days of randomization (baseline visit).
- Use supplemental coenzyme Q10 at a dose greater than 600 milligrams daily within 90 days of randomization (baseline visit).
- Are found to be using CoQ10 supplements totaling greater than 300mg daily. They are not allowed during the study but may be taken prior to the baseline visit.
This is a partial list of eligibility requirements.