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Sponsored by: |
University of Louisville |
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Information provided by: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00605930 |
This study intends to study the safety and tolerance of the combination of pyruvate, creatine, and niacinamide over 6 months in patients with PSP.
Condition | Intervention | Phase |
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Progressive Supranuclear Palsy |
Dietary Supplement: Pyruvate, creatine, niacinamide Dietary Supplement: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
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. |
Estimated Enrollment: | 20 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
75% of subjects will be randomized to receive a combination bar of 2 gm of pyruvate and 1 gm of creatine, and a separate pill of 1 gm of niacinamide once a day for 24 weeks.
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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.
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2: Placebo Comparator
25% of subjects will be randomized to receive a placebo bar and placebo pill once a day for 24 weeks.
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Dietary Supplement: Placebo
25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
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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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Casey A Shepherd, MPH | 502-561-3101 | casey.shepherd@louisville.edu |
United States, Kentucky | |
Frazier Rehab | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Principal Investigator: Irene Litvan, MD |
Principal Investigator: | Irene Litvan, MD | University of Louisville, Division of Movement Disorders |
Responsible Party: | Division of Movement Disorders, University of Louisville ( Irene Litvan, Director ) |
Study ID Numbers: | 083.03, 420 |
Study First Received: | January 14, 2008 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00605930 |
Health Authority: | United States: Institutional Review Board |
Progressive Supranuclear Palsy PSP Nutriceutical |
Pyruvate Creatine Niacinamide |
Motor neuro-ophthalmic disorders Niacinamide Ganglion Cysts Eye Diseases Basal Ganglia Diseases Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases |
Ocular motility disorders Paralysis Ocular Motility Disorders Signs and Symptoms Movement Disorders Supranuclear Palsy, Progressive Progressive supranuclear palsy Neurologic Manifestations |
Vitamin B Complex Growth Substances Vitamins Physiological Effects of Drugs Nervous System Diseases |
Micronutrients Cranial Nerve Diseases Tauopathies Ophthalmoplegia Pharmacologic Actions |