Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Paced Auditory Serial Addition Task (PASAT) | Mean Difference (Final Values) 1.14 | -2.03–4.32 | 0.05 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Omega-3 fatty acids
Placebo or sham
- Placebo
Results by group
Paced Auditory Serial Addition Task (PASAT)
Baseline to 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lipoic Acid and Omega-3 Fatty Acids | 2.24 correct responses | 4.69 (Standard Deviation) | 21 |
| Placebo | 3.38 correct responses | 5.46 (Standard Deviation) | 21 |
Lipoic Acid and Omega-3 Fatty Acids
Placebo
p = 0.05; Mean Difference (Final Values) 1.14 (95% CI -2.03–4.32)
Stroop Color-Word Test
baseline to 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lipoic Acid and Omega-3 Fatty Acids | -5.59 seconds | 12.77 (Standard Deviation) | 23 |
| Placebo | -2.87 seconds | 7.01 (Standard Deviation) | 23 |
Lipoic Acid and Omega-3 Fatty Acids
Placebo
California Verbal Learning Test-II (CVLT-II)
baseline to 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lipoic Acid and Omega-3 Fatty Acids | 1.57 correct responses | 1.85 (Standard Deviation) | 23 |
| Placebo | 1.65 correct responses | 2.44 (Standard Deviation) | 23 |
Lipoic Acid and Omega-3 Fatty Acids
Placebo
Controlled Oral Word Association Test (COWAT)
baseline to 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lipoic Acid and Omega-3 Fatty Acids | 0.70 words | 7.71 (Standard Deviation) | 23 |
| Placebo | 0.39 words | 7.14 (Standard Deviation) | 23 |
Lipoic Acid and Omega-3 Fatty Acids
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Lipoic Acid and Omega-3 Fatty Acids | 26 | 2 (7.7%) | 0 |
| Placebo | 28 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Paced Auditory Serial Addition Task (PASAT)
Baseline to 12 weeks
Thinking and memoryStroop Color-Word Test
baseline to 12 weeks
Thinking and memoryCalifornia Verbal Learning Test-II (CVLT-II)
baseline to 12 weeks
Thinking and memoryControlled Oral Word Association Test (COWAT)
baseline to 12 weeks
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: * • A definite diagnosis of multiple sclerosis (MS) with relapsing remitting or secondary progressive course * Age 18 to 65 years, inclusive * A score two or more standard deviations below the mean in one or more of the following cognitive tests: PASAT, COWAT, CVLT -II, Stroop * Expanded Disability Status Scale (EDSS) 0-7.5, inclusive * Suboptimal omega-3 levels (plasma docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA] \< 5.0% of total plasma fatty acids) * If taking MS disease modifying medications, on stable dose for > 6 months preceding enrollment * Able to read and write English Exclusion Criteria: * • Moderate to severe depression (Beck Depression Inventory score > 19) * Any significant uncontrolled medical problem including diabetes requiring insulin. * MS relapse within the 30 days before screening * Abnormalities of coagulation or current use of prescription anticoagulants or antiplatelet agents. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are not excluded. * Fish intake of one 6 ounce serving > once a week less than 2 months prior to enrollment * Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 2 months prior to enrollment * Lipoic Acid supplementation less than 1 month prior to enrollment * Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion. * Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study. * Epilepsy or history of seizures. * Pregnancy or women not using a reliable form of contraception * Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color plates or sustained nystagmus or diplopia on primary gaze * Inability to complete the neuropsychological test battery at the screening visit * Participation in another intervention study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jun 2014
Main results due
May 2016
Finished
May 2016
Results posted
May 2017
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