A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
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|ClinicalTrials.gov Identifier: NCT00605930|
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Progressive Supranuclear Palsy||Dietary Supplement: Pyruvate, creatine, niacinamide Dietary Supplement: Placebo||Not Applicable|
There are no effective symptomatic or biologic treatments for progressive supranuclear palsy (PSP), a relatively rare neurodegenerative disease that presents late in life with relentless progressive postural balance disturbances, non-levodopa responsive parkinsonism, supranuclear vertical gaze palsy, pseudobulbar palsy, and frontal behavioral and dysexecutive symptoms. In light of currently proposed etiopathogenic mechanisms in PSP and based on successful experiments inhibiting cellular neurotoxicity, it is hypothesized that preservation of brain energy homeostasis may allow endogenous neuroprotective mechanisms to reverse or impede free radical injury or other neurotoxic events leading to neurodegeneration in this disease. An emerging literature has described the neuroprotective effects of pyruvate, (as a neuronal energy fuel and free radical scavenger); niacinamide, (which boosts cofactor NAD), and creatine, (which buffers and selectively parcels cellular energy utilization) in various animal models of brain injury or degeneration.
Ajay Verma et al. have further demonstrated a synergistic neuroprotective effect of these three nutrients in various neural injury models. We thus propose using these nutrients as a novel and safe neuroprotective approach for treating PSP patients. This randomized, double-blind, placebo, control pilot study will test the safety and tolerance of this nutrient combination over 6 months in patients with PSP, and will measure their transport across the blood brain barrier. In addition to clinical and neuropsychological outcome measures, brain creatine will also be evaluated using magnetic resonance spectroscopy before and after therapy
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Energy Metabolism in Neurodegenerative Diseases: A Randomized, Double Blind, Placebo-Controlled Clinical Pilot Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: Pyruvate, creatine, niacinamide
Pyruvate, creatine, niacinamide administered
Dietary Supplement: Pyruvate, creatine, niacinamide
A bar of 2 gm of pyruvate and 1 gm of creatine, and a pill of 1 gm of niacinamide once a day for 24 weeks.
Placebo Comparator: Placebo
Dietary Supplement: Placebo
25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
- Clinical features of PSP, including motor function, neuropsychological function, and blood chemistry [ Time Frame: Baseline, 4 weeks, 24 weeks ]
- CSF metabolite concentrations [ Time Frame: Baseline, 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605930
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Irene Litvan, MD||University of Louisville, Division of Movement Disorders|