Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026988
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-11-15
Brief Title:
Creatine Therapy for Huntingtons Disease
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Creatine Therapy for Huntingtons Disease
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study CREST-HD will examine the safety and tolerability of 8 grams of creatine in subjects affected by Huntingtons disease HD Biochemistry and neuroimaging will be used to examine the potential effects of creatine on HD
Detailed Description:
Huntingtons disease HD is a progressive and fatal neurologic disorder caused by an expanded CAG repeat in the gene coding for a protein of unknown function that has been named huntingtin The exact cause of neuronal death in HD is unknown however the leading hypothesis is that of excitotoxicity and apoptosis induced by a defect in energy metabolism that may be caused by oxidative stress We previously demonstrated that mitochondrial inhibitors produce striatal lesions closely mimicking the phenotype of HD We have also shown that oxidative injury is involved in these models and may be in human HD Because of this research there has been increasing interest in the HD field in exploring complementary agents that might prevent oxidative injury Creatine is a widely used dietary supplement principally taken to enhance athletic performance It is a very strong candidate neuroprotective agent for HD and other neurodegenerative disorders because of its ability to ameliorate toxin-based animal models and because of our preliminary evidence in transgenic HD mice However there is only limited animal experience with creatine and there has not yet been any trials in humans with neurodegenerative disorders There are several potential mechanisms by which creatine could be an effective treatment for HD First there is evidence that it can be neuroprotective by relieving oxidative stress Second it could directly inhibit apoptotic neuronal death through its inhibitory action on the mitochondrial transition pore Third we have preliminary evidence that creatine treatment may be associated with reduced huntingtin aggregation a potentially toxic process Finally it could act peripherally to help reverse the weakness and muscle mass loss that is a major clinical problem in HD We have preliminary evidence that creatine can extend survival in transgenic models of HD and that it can reduce brain markers of metabolic stress in humans with HD We propose to test whether creatine can ameliorate the behavioral and neuropathologic phenotypes occurring in transgenic models of HD examine the potential mechanisms of creatine neuroprotection test its safety and tolerability in HD patients and collect pilot clinical data examining how creatine impacts HD symptoms and progression These studies are intended to provide the basis of a subsequent phase III trial of creatine in HD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None