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

NCT02133664 | Completed Phase 1 Results DMC

• 1 other identifier: PP2190
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Cognition

Keywords

multiple sclerosis; cognition; clinical trial; thiotic acid; Omega-3 fatty acids

Outcome Measures

Primary Outcomes (4)

• Paced Auditory Serial Addition Task (PASAT)

  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

  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)

  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)

  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

Study Arms (2)

lipoic acid and omega-3 fatty acids

EXPERIMENTAL

lipoic acid and omega-3 fatty acids

Drug: lipoic acid and omega-3 fatty acids

placebo

PLACEBO COMPARATOR

placebo oil and placebo lipoic acid

Drug: Placebo

Interventions

lipoic acid and omega-3 fatty acids 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

Also known as: thiotic acid, fish oil, fish oil concentrate

lipoic acid and omega-3 fatty acids

Placebo DRUG

placebo lipoic acid and placebo oil

Also known as: placebo lipoic acid and placebo oil

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Thioctic Acid; Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Oils

Results Point of Contact

• Title: Lynne Shinto, ND, MPH
• Organization: Oregon Health & Science University

shintol@ohsu.edu

503-494-5035

Study Officials

• Lynne Shinto, ND, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 2, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-05

Locations

US (1)