Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis

NCT02133664, Phase 1, Phase 2, Completed, Oregon Health and Science University; results first posted 2017-05-03

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis	ClinicalTrials.gov
NCT number	NCT02133664	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Phase 1, Phase 2	ClinicalTrials.gov
Enrollment	54 participants, actual	ClinicalTrials.gov
Lead sponsor	Oregon Health and Science University	ClinicalTrials.gov
Conditions	Multiple Sclerosis, Cognition	ClinicalTrials.gov
Interventions	lipoic acid and omega-3 fatty acids, Placebo	ClinicalTrials.gov
First posted	2014-05-08	ClinicalTrials.gov
Last updated	2017-06-02	ClinicalTrials.gov
Results first posted	2017-05-03	ClinicalTrials.gov

Registered outcomes 4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Paced Auditory Serial Addition Task (PASAT)	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.	ClinicalTrials.gov
Primary	Stroop Color-Word Test	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.	ClinicalTrials.gov
Primary	California Verbal Learning Test-II (CVLT-II)	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.	ClinicalTrials.gov
Primary	Controlled Oral Word Association Test (COWAT)	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.	ClinicalTrials.gov

Outcomes 4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Paced Auditory Serial Addition Task (PASAT)	Baseline to 12 weeks	Only participants who completed PASAT at both baseline and 12 weeks were analyzed.	correct responses	MEAN	ClinicalTrials.gov
PRIMARY	Stroop Color-Word Test	baseline to 12 weeks	Analysis occurs only for participants who completed Stroop at both baseline and 12 weeks	seconds	MEAN	ClinicalTrials.gov
PRIMARY	California Verbal Learning Test-II (CVLT-II)	baseline to 12 weeks	Only participants who completed CVLT-II at baseline and 12 weeks were analyzed	correct responses	MEAN	ClinicalTrials.gov
PRIMARY	Controlled Oral Word Association Test (COWAT)	baseline to 12 weeks	Only participant who completed COWAT at both baseline and 12 weeks were analyzed	words	MEAN	ClinicalTrials.gov

Results by group 8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
Paced Auditory Serial Addition Task (PASAT)	Lipoic Acid and Omega-3 Fatty Acids	2.24	Standard Deviation 4.69	correct responses	ClinicalTrials.gov
Paced Auditory Serial Addition Task (PASAT)	Placebo	3.38	Standard Deviation 5.46	correct responses	ClinicalTrials.gov
Stroop Color-Word Test	Lipoic Acid and Omega-3 Fatty Acids	-5.59	Standard Deviation 12.77	seconds	ClinicalTrials.gov
Stroop Color-Word Test	Placebo	-2.87	Standard Deviation 7.01	seconds	ClinicalTrials.gov
California Verbal Learning Test-II (CVLT-II)	Lipoic Acid and Omega-3 Fatty Acids	1.57	Standard Deviation 1.85	correct responses	ClinicalTrials.gov
California Verbal Learning Test-II (CVLT-II)	Placebo	1.65	Standard Deviation 2.44	correct responses	ClinicalTrials.gov
Controlled Oral Word Association Test (COWAT)	Lipoic Acid and Omega-3 Fatty Acids	0.70	Standard Deviation 7.71	words	ClinicalTrials.gov
Controlled Oral Word Association Test (COWAT)	Placebo	0.39	Standard Deviation 7.14	words	ClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Lipoic Acid and Omega-3 Fatty Acids	26	ClinicalTrials.gov
Overall Study	STARTED	Placebo	28	ClinicalTrials.gov
Overall Study	COMPLETED	Lipoic Acid and Omega-3 Fatty Acids	21	ClinicalTrials.gov
Overall Study	COMPLETED	Placebo	21	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Lipoic Acid and Omega-3 Fatty Acids	5	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Placebo	7	ClinicalTrials.gov

Adverse events 26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Source
other	Throat irritation	Gastrointestinal disorders	Lipoic Acid and Omega-3 Fatty Acids	3	26	ClinicalTrials.gov
other	Throat irritation	Gastrointestinal disorders	Placebo	0	28	ClinicalTrials.gov
other	Dysphagia	Gastrointestinal disorders	Lipoic Acid and Omega-3 Fatty Acids	0	26	ClinicalTrials.gov
other	Dysphagia	Gastrointestinal disorders	Placebo	2	28	ClinicalTrials.gov
other	Fall	Injury, poisoning and procedural complications	Lipoic Acid and Omega-3 Fatty Acids	0	26	ClinicalTrials.gov
other	Fall	Injury, poisoning and procedural complications	Placebo	4	28	ClinicalTrials.gov
other	Fatigue	General disorders	Lipoic Acid and Omega-3 Fatty Acids	3	26	ClinicalTrials.gov
other	Fatigue	General disorders	Placebo	1	28	ClinicalTrials.gov
other	Adverse drug reaction	Gastrointestinal disorders	Lipoic Acid and Omega-3 Fatty Acids	2	26	ClinicalTrials.gov
other	Adverse drug reaction	Gastrointestinal disorders	Placebo	0	28	ClinicalTrials.gov
other	Headache	Nervous system disorders	Lipoic Acid and Omega-3 Fatty Acids	2	26	ClinicalTrials.gov
other	Headache	Nervous system disorders	Placebo	0	28	ClinicalTrials.gov
other	Dyspepsia	Gastrointestinal disorders	Lipoic Acid and Omega-3 Fatty Acids	4	26	ClinicalTrials.gov
other	Dyspepsia	Gastrointestinal disorders	Placebo	1	28	ClinicalTrials.gov
other	Nausea	Gastrointestinal disorders	Lipoic Acid and Omega-3 Fatty Acids	6	26	ClinicalTrials.gov
other	Nausea	Gastrointestinal disorders	Placebo	2	28	ClinicalTrials.gov
other	Urine odor abnormal	Renal and urinary disorders	Lipoic Acid and Omega-3 Fatty Acids	4	26	ClinicalTrials.gov
other	Urine odor abnormal	Renal and urinary disorders	Placebo	0	28	ClinicalTrials.gov
other	Incontinence	Renal and urinary disorders	Lipoic Acid and Omega-3 Fatty Acids	2	26	ClinicalTrials.gov
other	Incontinence	Renal and urinary disorders	Placebo	1	28	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Lipoic Acid and Omega-3 Fatty Acids	0	26	ClinicalTrials.gov
Total, all-cause mortality	Placebo	0	28	ClinicalTrials.gov
Total, other adverse events	Lipoic Acid and Omega-3 Fatty Acids	21	26	ClinicalTrials.gov
Total, other adverse events	Placebo	12	28	ClinicalTrials.gov
Total, serious adverse events	Lipoic Acid and Omega-3 Fatty Acids	2	26	ClinicalTrials.gov
Total, serious adverse events	Placebo	0	28	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lipoic Acid and Omega-3 Fatty Acids vs Placebo: deaths from any cause	Trial comparisons
Lipoic Acid and Omega-3 Fatty Acids vs Placebo: serious adverse events	Trial comparisons

Tests 4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Paced Visual Serial Addition Test	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition
Verbal Learning	Primary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)