A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00605930
First received: January 14, 2008
Last updated: April 2, 2014
Last verified: April 2014
  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.

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Clinical features of PSP, including motor function, neuropsychological function, and blood chemistry [ Time Frame: Baseline, 4 weeks, 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CSF metabolite concentrations [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: December 2009
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.
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605930

Locations
United States, Kentucky
Frazier Rehab
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Irene Litvan, MD University of Louisville, Division of Movement Disorders
  More Information

No publications provided

Responsible Party: 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: April 2, 2014
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 July 23, 2014