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

Progressive Supranuclear Palsy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01537549
• Other study ID #: IRB1006011088
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: September 5, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• alpha-lipoic acid and L-acetyl carnitine
alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	change of incidence and severity of adverse events	at baseline, 4, 12 and 24 weeks	Yes
Secondary	Clinical assessments	changes of scores for UPDRS, Golbe PSP Rating Scale, Hoehn and Yahr Scale and neuropsychological tests	at baseline, at weeks 5, 13, 25	No
Secondary	Quality of life	changes of scores for PSP quality of life questionnaire (PSP QOL)	at baseline, at weeks 5, 13, 25	No
Secondary	Routine safety laboratory parameters	Changes in; Electrolyte panel (CPT 80051); Liver function panel (CPT 80076); CBC (CPT 85027)	at baseline, at weeks 5, 13, 25	Yes
Secondary	Cerebral oxidative stress markers	changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy	at baseline and at week 5	No