A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35233, United States
Phoenix, Arizona 85013, United States
Fountain Valley, California 92708, United States
Los Angeles, California 90033, United States
San Francisco, California 94143-0114, United States
Denver, Colorado 80262, United States
Gainesville, Florida 32608, United States
Gainesville, Florida 32610, United States
Jacksonville, Florida 32209, United States
Miami, Florida 33136, United States
Tampa, Florida 33606, United States
Atlanta, Georgia 30329, United States
Augusta, Georgia 30912, United States
Honolulu, Hawaii 96817, United States
Chicago, Illinois 60612, United States
Glenview, Illinois 60026, United States
Springfield, Illinois 62794-9645, United States
Indianapolis, Indiana 46202, United States
Kansas City, Kansas 66160-7314, United States
Lexington, Kentucky 40536-0284, United States
New Orleans, Louisiana 70121, United States
Shreveport, Louisiana 71130, United States
Baltimore, Maryland 21201, United States
Baltimore, Maryland 21287-0875, United States
Boston, Massachusetts 02115, United States
Boston, Massachusetts 02215, United States
Ann Arbor, Michigan 48109-0028, United States
East Lansing, Michigan 48824, United States
St Louis, Missouri 63110, United States
Lebanon, New Hampshire 03756, United States
New Brunswick, New Jersey 08901, United States
Brooklyn, New York 11203-2098, United States
Manhasset, New York 11030, United States
Durham, North Carolina 27705, United States
Portland, Oregon 97239, United States
Philadelphia, Pennsylvania 19107, United States
Philadelphia, Pennsylvania 19107, United States
Wynnewood, Pennsylvania 19096, United States
Charleston, South Carolina 29401, United States
Nashville, Tennessee 37212, United States
Dallas, Texas 75390-9016, United States
Burlington, Vermont 05405, United States
Charlottesville, Virginia 22903, United States
Calgary, Alberta T2N4NI, Canada