A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Progressive Supranuclear Palsy |
Dietary Supplement: Pyruvate, creatine, niacinamide Dietary Supplement: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
- Clinical features of PSP, including motor function, neuropsychological function, and blood chemistry [ Time Frame: Baseline, 4 weeks, 24 weeks ] [ Designated as safety issue: Yes ]
- CSF metabolite concentrations [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
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.
|
|
Placebo Comparator: 2
25% of subjects will be randomized to receive a placebo bar and placebo pill once a day for 24 weeks.
|
Dietary Supplement: Placebo
25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
|
Detailed Description:
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All subjects must meet the clinically definite or probable NINDS-SPSP PSP diagnostic research criteria that includes the presence of postural instability at disease onset, as well as supranuclear vertical ophthalmoparesis.
- All subjects must be able to tolerate oral feedings and be ambulatory
- All subjects or their caregivers must be able to read and understand the consent
Exclusion Criteria:
- Any contraindications to the use of pyruvate, creatine, and niacinamide
- the presence of a medical condition that can reasonably be expected to subject the patient to unwarranted risk or require frequent changes in medication.
- Pregnancy, nursing, or lack of effective contraception, if still at child-bearing age.
- History of prior sever traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury, which will interfere with outcome evaluation, in the opinion of the local principal investigator
- Subject unable to discontinue prohibited medication, which includes antiparkinsonian medications with potential neuroprotective effects such as amantadine, deprenyl, and vitamin E supplements > 400 IU per day.
Contacts and Locations| United States, Kentucky | |
| Frazier Rehab | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | Irene Litvan, MD | University of Louisville, Division of Movement Disorders |
More Information
Additional Information:
No publications provided
| Responsible Party: | Irene Litvan, Director, Division of Movement Disorders, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00605930 History of Changes |
| Other Study ID Numbers: | 083.03, 420 |
| Study First Received: | January 14, 2008 |
| Last Updated: | August 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Louisville:
|
Progressive Supranuclear Palsy PSP Nutriceutical |
Pyruvate Creatine Niacinamide |
Additional relevant MeSH terms:
|
Supranuclear Palsy, Progressive Paralysis Neurodegenerative Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Neurologic Manifestations Eye Diseases Signs and Symptoms |
Niacinamide Niacin Nicotinic Acids Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013