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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis, Cognition

In brief

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.

Key facts

Study ID

NCT02133664

Run by

Oregon Health and Science University

People needed

54

Starts

2014-06-01

Expected to finish

2016-05-01

Last updated by the study team

2017-06-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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