Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT02133664|
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : May 3, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Cognition||Drug: lipoic acid and omega-3 fatty acids Drug: Placebo||Phase 1 Phase 2|
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 soluble intercellular adhesion molecule-1 (sICAM-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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids
Drug: lipoic acid and omega-3 fatty acids
alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid
Placebo Comparator: placebo
placebo oil and placebo lipoic acid
placebo lipoic acid and placebo oil
Other Name: placebo lipoic acid and placebo oil
- Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Baseline to 12 weeks ]The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.
- Stroop Color-Word Test [ Time Frame: baseline to 12 weeks ]The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word "yellow" may be red, the word "blue" may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.
- California Verbal Learning Test-II (CVLT-II) [ Time Frame: baseline to 12 weeks ]CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of "shopping list" items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome.
- Controlled Oral Word Association Test (COWAT) [ Time Frame: baseline to 12 weeks ]The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133664
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Lynne Shinto, ND, MPH||Oregon Health and Science University|