Phase 2
N=11
Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy
Progressive Supranuclear Palsy
Bottom Line
View on ClinicalTrials.gov: NCT01537549 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Apr 2017
Primary outcome: Primary: Adverse Events — 23 Number of Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alpha-lipoic acid and L-acetyl carnitine (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
23 | — |
| SECONDARY Cerebral Oxidative Stress Markers |
4; 4.6 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01537549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.