Conditions: Parkinson's Disease
Keywords: Parkinson's disease creatine NET-PD neuroprotection PD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1741
Healthy volunteers: no

Brief summary:
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: creatine intervention 2: placebo
Intervention descriptions: intervention 1: 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. intervention 2: an inactive substance

Protocol document: