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

May 2, 2017 updated by: Lynne Shinto, Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lipoic acid and omega-3 fatty acids
Drug: 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
Other Names:
  • fish oil
  • thiotic acid
  • fish oil concentrate
Placebo Comparator: placebo
placebo oil and placebo lipoic acid
Drug: Placebo
placebo lipoic acid and placebo oil
Other Names:
  • placebo lipoic acid and placebo oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paced Auditory Serial Addition Task (PASAT)
Time Frame: Baseline to 12 weeks
The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.
Baseline to 12 weeks
Stroop Color-Word Test
Time Frame: baseline to 12 weeks
The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word "yellow" may be red, the word "blue" may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.
baseline to 12 weeks
California Verbal Learning Test-II (CVLT-II)
Time Frame: baseline to 12 weeks
CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of "shopping list" items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome.
baseline to 12 weeks
Controlled Oral Word Association Test (COWAT)
Time Frame: baseline to 12 weeks
The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Multiple Sclerosis Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP2190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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