Phase 2
Completed N=54
Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
Multiple Sclerosis · Cognition
Source: ClinicalTrials.gov NCT02133664 ↗
Enrolled (actual)
54
Serious AEs
3.7%
Results posted
May 2017
Primary outcomePrimary: Paced Auditory Serial Addition Task (PASAT) — 2.24; 3.38 correct responses — p=0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paced Auditory Serial Addition Task (PASAT) |
2.24; 3.38 | 0.05 |
| PRIMARY Stroop Color-Word Test |
-5.59; -2.87 | — |
| PRIMARY California Verbal Learning Test-II (CVLT-II) |
1.57; 1.65 | — |
| PRIMARY Controlled Oral Word Association Test (COWAT) |
0.70; 0.39 | — |
Eligibility Criteria
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] 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
Data sourced from ClinicalTrials.gov (NCT02133664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.