- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026988
Creatine Therapy for Huntington's Disease
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
This study, CREST-HD, will examine the safety and tolerability of 8 grams of creatine in subjects affected by Huntington's disease (HD).
Biochemistry and neuroimaging will be used to examine the potential effects of creatine on HD.
Study Overview
Detailed Description
Huntington's 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 Type
Interventional
Enrollment
64
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Steven Hersch, M.D., Ph.D.
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New York
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Long Island, New York, United States
- Andrew Feigin, M.D.
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New York, New York, United States, 10032
- Karen Marder, M.D.
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Rochester, New York, United States, 14642
- Peter Como, Ph.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Diagnosis of HD confirmed by known family history or by CAG repeat expansion >37.
- Clinical stage I or II as determined by a functional capacity scale >7; must have evident motor signs
- Men and women >18 years if age with a clinical diagnosis of HD. Women of childbearing age may participate if they have a negative pregnancy test at screening and are either using adequate birth control, post menopausal, or are surgically sterile.
- Stable doses of any psychotropic medications for 4 weeks prior to randomization and should be maintained on constant dosage throughout the course of the trial.
- Capable of providing informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Hersch, MD, Harvard School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
November 15, 2001
First Submitted That Met QC Criteria
November 15, 2001
First Posted (ESTIMATE)
November 16, 2001
Study Record Updates
Last Update Posted (ESTIMATE)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
Other Study ID Numbers
- R01AT000613-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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