A Pilot Clinical Trial of Pyruvate, Creatine, & Niacinamide in Progressive

Status Completed

Clinical Trial Summary

This study intends to study the safety and tolerance of the combination of pyruvate, creatine, and niacinamide over 6 months in patients with PSP.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00605930
Study type	Interventional
Source	University of Louisville
Contact
Status	Completed
Phase	N/A
Start date	April 2004
Completion date	December 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04096651` - Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy	N/A
Recruiting	`NCT02194816` - Modifiable Variables in Parkinsonism (MVP)
Completed	`NCT00703677` - A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration	Phase 1/Phase 2
Completed	`NCT00382824` - Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)	N/A
Completed	`NCT04184063` - Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)	Phase 2
Recruiting	`NCT04706234` - Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
Recruiting	`NCT04472130` - Neurodegenerative Diseases Registry
Recruiting	`NCT04139551` - Oxford Study of Quantification in Parkinsonism
Completed	`NCT02734485` - Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy	N/A
Completed	`NCT01110720` - Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy	Phase 2/Phase 3
Completed	`NCT01174771` - Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration	N/A
Completed	`NCT00465790` - Research of Biomarkers in Parkinson Disease	Phase 0
Completed	`NCT02460094` - Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy	Phase 1
Active, not recruiting	`NCT04993768` - A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)	Phase 2
Recruiting	`NCT03225144` - Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Completed	`NCT03058965` - Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain	Early Phase 1
Recruiting	`NCT02605785` - A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy	N/A
Completed	`NCT01353183` - Analysis of the Enteric Nervous System Using Colonic Biopsies	N/A
Completed	`NCT00385710` - Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)	Phase 2
Recruiting	`NCT05260151` - Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms