Creatine Safety, Tolerability & Efficacy in huntington’s Disease.
WHAT IS THE TITLE OF THE STUDY?
Creatine Safety, Tolerability & Efficacy in Huntington’s Disease (CREST-E)
WHAT IS THE PURPOSE OF THE STUDY?
The purpose of this study is to assess whether high doses of creatine can slow down the worsening of Huntington’s Disease (HD) symptoms that occurs over time.
WHO IS NEEDED?
- Volunteers must either be diagnosed with HD with confirmatory family history OR a CAG repeat expansion ≥36.
- Volunteers must be in Stage I or II of illness (TFC ≥ 7).
- Volunteers must be ambulatory and not requiring skilled nursing care at the time of enrollment.
- Volunteers currently taking psychotropic drugs (including antidepressants and neuroleptics) must be on stable dosages for at least 30 days prior to randomization.
- Volunteers must NOT have a history of known sensitivity or intolerability to creatine monohydrate.
- Volunteers must NOT have current or history of substance (alcohol or drug) abuse within one year of beginning the study.
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: This study involves having sixteen study visits and eighteen telephone contacts over three years. If you have a caregiver, he or she may also participate in this study, as we are also trying to gather information about how people feel when taking care of another person. Caregiver participation is not mandatory, and his or her participation would be limited to answering questions.
Tests/Procedures: physical and neurological exam with HD ratings, blood draws, urine samples, electrocardiogram (EKG/ECG), DNA testing, questionnaires
Risks: Risks will be discussed with volunteers as part of the informed consent process.
Benefits: You may or may not receive any direct benefit from participation in this study, but participation will contribute to our knowledge of HD and may help future patients.
WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?
Brad Racette, MD
WHERE WILL THE STUDY TAKE PLACE?
Washington University School of Medicine
Coordinator Name: Patricia Deppen, RN, MA
Tel: (314) 362-8548 Email: firstname.lastname@example.org