Huntington's Disease
Conditions
Keywords
Huntington's disease, Creatine, Mitochondrial Dysfunction, Total Functional Capacity, UHDRS
Brief summary
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.Creatine monohydrate is considered a nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40 grams daily creatine compared to placebo is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.
Interventions
DRUGCreatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
DRUGPlacebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Sponsors
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ages 18 or older. * Clinical features of HD AND confirmatory family history of HD; OR Clinical features of HD AND CAG repeat expansion greater or equal to 36. * Stage I or II of illness (TFC greater or equal to 7). * Ambulatory and not requiring skilled nursing care at the time of enrollment. * Must be capable of providing informed consent and complying with trial procedures. * Additional inclusion criteria apply.
Exclusion criteria
* History of known sensitivity or intolerability to creatine monohydrate. * Exposure to any investigational drug within 30 days of randomization (Baseline visit). * Use of supplemental creatine at a dose greater than 10 grams within 30 days of randomization (Baseline visit). * Screening laboratory abnormalities that in the judgment of the investigator would jeopardize safe conduct of study. * Clinical evidence of unstable medical illness. * Clinical evidence of unstable psychiatric illness. * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Functional Capacity | Minimum 12 months up to 48 months | Study duration depends on each subject's calendar date of enrollment. |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms (changes in other UHDRS scores); safety (frequency of adverse events); tolerability (proportion of subjects completing study at assigned dosage level), quality of life, other biological markers. | Duration of the trial |
Countries
Australia, Canada, New Zealand, United States
Outcome results
None listed