A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
NCT ID: NCT00605930
Last Updated: 2017-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2004-04-30
2009-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pyruvate, creatine, niacinamide
Pyruvate, creatine, niacinamide administered
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
placebo
Placebo
25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
Interventions
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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
25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Principal Investigators
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Irene Litvan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville, Division of Movement Disorders
Locations
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Frazier Rehab
Louisville, Kentucky, United States
Countries
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Related Links
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Related Info
Other Identifiers
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420
Identifier Type: -
Identifier Source: secondary_id
083.03
Identifier Type: -
Identifier Source: org_study_id
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