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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,741
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. The study is comparing creatine 5 grams twice daily with placebo.
an inactive substance
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Time frame: Change from baseline to 5 YEARS
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University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
Birmingham, Alabama, United States
Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
Phoenix, Arizona, United States
Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
Fountain Valley, California, United States
University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
Los Angeles, California, United States
University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
San Francisco, California, United States
The Parkinson's Institute, 675 Almanor Avenue
Sunnyvale, California, United States
University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
Denver, Colorado, United States
Neurodegenerative Disorders, 60 Temple Street Suite 8b
New Haven, Connecticut, United States
VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
Gainesville, Florida, United States
University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
Gainesville, Florida, United States
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