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

NCT ID: NCT02133664

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-05-31

Brief 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.

Detailed Description

The study is designed as a randomized, double-blind, placebo-controlled pilot trial. The primary aim of the study is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function over 12-weeks in people with multiple sclerosis that have a baseline score of at least two standard deviations below normative values on any one of four cognitive tests that include, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word Test, California Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association Test (COWAT).

The secondary aim is to determine treatment effects on markers of endothelial inflammation, insulin dysregulation, and mitochondrial dysfunction that may be related to cognitive dysfunction by measuring soluble intercellular adhesion molecule-1 (sICAM-1) levels, homeostasis model of insulin resistance (HOMA-IR), and MRI phosphorus imaging in a subset of study participants. The study will also measure safety by adverse event reports and laboratory measures; plasma fatty acid levels; serum lipoic acid levels.

Conditions

Multiple Sclerosis; Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids

Group Type: EXPERIMENTAL

lipoic acid and omega-3 fatty acids

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo lipoic acid and placebo oil

Interventions

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

Intervention Type: DRUG

Placebo

placebo lipoic acid and placebo oil

Intervention Type: DRUG

Other Intervention Names

thiotic acid; fish oil; fish oil concentrate; placebo lipoic acid and placebo oil

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] < 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lynne Shinto

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynne Shinto, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

PP2190

Identifier Type: -

Identifier Source: org_study_id