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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: National Multiple Sclerosis Society
• Treatments: Thioctic Acid

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] < 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