Overview

This trial is active, not recruiting.

Condition progressive supranuclear palsy
Treatment alpha-lipoic acid and l-acetyl carnitine
Phase phase 1
Sponsor Weill Medical College of Cornell University
Start date December 2011
End date December 2013
Trial size 15 participants
Trial identifier NCT01537549, IRB1006011088

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
alpha-lipoic acid and l-acetyl carnitine Juvenon
alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months

Primary Outcomes

Measure
Adverse events
time frame: at baseline, 4, 12 and 24 weeks

Secondary Outcomes

Measure
Clinical assessments
time frame: at baseline, at weeks 5, 13, 25
Quality of life
time frame: at baseline, at weeks 5, 13, 25
Routine safety laboratory parameters
time frame: at baseline, at weeks 5, 13, 25
Cerebral oxidative stress markers
time frame: at baseline and at week 5

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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)

Additional Information

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
Principal investigator Claire Henchcliffe, MD DPhil
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.