Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01537549
First received: January 9, 2012
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

Studies have shown that alpha-lipoic acid and L-acetyl carnitine may have some neuroprotective activities and it is hoped that they could be helpful for people with neurodegenerative illnesses such as progressive supranuclear palsy (PSP).

The purpose of this study is to find out whether the nutritional supplement alpha-lipoic acid/L-acetyl carnitine is safe and well-tolerated in individuals with PSP when given daily, and whether it affects their well-being, brain scan measurements and blood tests that measure the energy metabolism in cells.


Condition Intervention Phase
Progressive Supranuclear Palsy
Drug: alpha-lipoic acid and L-acetyl carnitine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Trial of Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy (PSP): Effect Upon Oxidative Damage and Mitochondrial Biomarkers

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Adverse events [ Time Frame: at baseline, 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
    change of incidence and severity of adverse events


Secondary Outcome Measures:
  • Clinical assessments [ Time Frame: at baseline, at weeks 5, 13, 25 ] [ Designated as safety issue: No ]
    changes of scores for UPDRS, Golbe PSP Rating Scale, Hoehn and Yahr Scale and neuropsychological tests

  • Quality of life [ Time Frame: at baseline, at weeks 5, 13, 25 ] [ Designated as safety issue: No ]
    changes of scores for PSP quality of life questionnaire (PSP QOL)

  • Routine safety laboratory parameters [ Time Frame: at baseline, at weeks 5, 13, 25 ] [ Designated as safety issue: Yes ]

    Changes in

    • Electrolyte panel (CPT 80051)
    • Liver function panel (CPT 80076)
    • CBC (CPT 85027)

  • Cerebral oxidative stress markers [ Time Frame: at baseline and at week 5 ] [ Designated as safety issue: No ]
    changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy


Estimated Enrollment: 15
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juvenon Drug: alpha-lipoic acid and L-acetyl carnitine
alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Other Name: Juvenon

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable PSP by NINDS/PSP workshop criteria (see patient folder)
  • Age 40-75 years
  • Able to undergo MRI
  • Absence of significant medical, psychiatric, and other neurological disease
  • Stable intake of supplements and medication

Exclusion Criteria:

  • Failure to meet probable PSP diagnosis by NINDS/PSP workshop criteria
  • unable to comply with informed consent process
  • unable to undergo MRI
  • presence of significant medical, psychiatric (incl MDD) or other neurological (incl epilepsy, brain tumor, stroke) disease
  • possibility of pregnancy (negative test required in women of childbearing age)
  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: NCT01537549

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Claire Henchcliffe, MD DPhil Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01537549     History of Changes
Other Study ID Numbers: IRB1006011088
Study First Received: January 9, 2012
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Progressive supranuclear palsy
alpha-lipoic acid
L-acetyl carnitine
antioxidant
magnetic resonance spectroscopy
neurodegeneration
glutathione

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Paralysis
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Acetylcarnitine
Carnitine
Thioctic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 21, 2014