Trial Outcomes & Findings for Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis (NCT NCT02133664)
NCT ID: NCT02133664
Last Updated: 2017-06-02
Results Overview
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.
COMPLETED
PHASE1/PHASE2
54 participants
Baseline to 12 weeks
2017-06-02
Participant Flow
49 participants were excluded from the study for the following: did not meet inclusion criteria (i.e. test scores too high, colorblindness, unclear cognitive status), declined to participate, could not consent, lost to follow-up, and started fish oil.
Participant milestones
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
lipoic acid and omega-3 fatty acids
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
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
lipoic acid and omega-3 fatty acids
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
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
6
|
Baseline Characteristics
Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=26 Participants
lipoic acid and omega-3 fatty acids
Alpha 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
n=28 Participants
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
49.34 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
52.96 years
STANDARD_DEVIATION 8.85 • n=7 Participants
|
51.22 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only participants who completed PASAT at both baseline and 12 weeks were analyzed.
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.
Outcome measures
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=21 Participants
lipoic acid and omega-3 fatty acids
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
n=21 Participants
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Paced Auditory Serial Addition Task (PASAT)
|
2.24 correct responses
Standard Deviation 4.69
|
3.38 correct responses
Standard Deviation 5.46
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Analysis occurs only for participants who completed Stroop at both baseline and 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.
Outcome measures
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=23 Participants
lipoic acid and omega-3 fatty acids
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
n=23 Participants
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Stroop Color-Word Test
|
-5.59 seconds
Standard Deviation 12.77
|
-2.87 seconds
Standard Deviation 7.01
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Only participants who completed CVLT-II at baseline and 12 weeks were analyzed
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.
Outcome measures
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=23 Participants
lipoic acid and omega-3 fatty acids
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
n=23 Participants
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
California Verbal Learning Test-II (CVLT-II)
|
1.57 correct responses
Standard Deviation 1.85
|
1.65 correct responses
Standard Deviation 2.44
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Only participant who completed COWAT at both baseline and 12 weeks were analyzed
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.
Outcome measures
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=23 Participants
lipoic acid and omega-3 fatty acids
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
n=23 Participants
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Controlled Oral Word Association Test (COWAT)
|
0.70 words
Standard Deviation 7.71
|
0.39 words
Standard Deviation 7.14
|
Adverse Events
Lipoic Acid and Omega-3 Fatty Acids
Placebo
Serious adverse events
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=26 participants at risk
lipoic acid and omega-3 fatty acids
Alpha 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
n=28 participants at risk
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Renal and urinary disorders
Kidney Infection
|
3.8%
1/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Ear and labyrinth disorders
Deafness unilateral
|
3.8%
1/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
Other adverse events
| Measure |
Lipoic Acid and Omega-3 Fatty Acids
n=26 participants at risk
lipoic acid and omega-3 fatty acids
Alpha 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
n=28 participants at risk
placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil
|
|---|---|---|
|
Gastrointestinal disorders
Throat irritation
|
11.5%
3/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • 12 weeks
|
14.3%
4/28 • 12 weeks
|
|
General disorders
Fatigue
|
11.5%
3/26 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Gastrointestinal disorders
Adverse drug reaction
|
7.7%
2/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
4/26 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
23.1%
6/26 • 12 weeks
|
7.1%
2/28 • 12 weeks
|
|
Renal and urinary disorders
Urine odor abnormal
|
15.4%
4/26 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Renal and urinary disorders
Incontinence
|
7.7%
2/26 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
7.7%
2/26 • 12 weeks
|
3.6%
1/28 • 12 weeks
|
Additional Information
Lynne Shinto, ND, MPH
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place