Multiple Sclerosis Clinical Trial
Official title:
Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
The primary aim is to collect data to determine the correct effect size on the primary outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis that have cognitive dysfunction.
The study is designed as a randomized, double-blind, placebo-controlled pilot trial. The
primary aim of the study is to determine if lipoic acid and omega-3 fatty acids can improve
cognitive function over 12-weeks in people with multiple sclerosis that have a baseline
score of at least two standard deviations below normative values on any one of four
cognitive tests that include, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word
Test, California Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association
Test (COWAT).
The secondary aim is to determine treatment effects on markers of endothelial inflammation,
insulin dysregulation, and mitochondrial dysfunction that may be related to cognitive
dysfunction by measuring s-ICAM-1 levels, homeostasis model of insulin resistance (HOMA-IR),
and MRI phosphorus imaging in a subset of study participants. The study will also measure
safety by adverse event reports and laboratory measures; plasma fatty acid levels; serum
lipoic acid levels.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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