Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Miami
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Accera, Inc.
Information provided by (Responsible Party):
Melissa Ortega, M.D, University of Miami
ClinicalTrials.gov Identifier:
NCT01848327
First received: April 16, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple Sclerosis (MS). Treatment options are limited, and there is a pressing need for new interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose is not converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this problem by providing an alternative energy source that is metabolized in the liver and used by the brain.

Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on cognitive impairment in multiple sclerosis.

Design: Randomized, double blinded, placebo controlled trial of 158 subjects.

Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90


Condition Intervention Phase
Relapsing Remitting MS
Secondary Progressive MS
Primary Progressive MS
Dietary Supplement: Caprylic Triglyceride
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80) [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    measure of verbal learning and memory

  • Change in Symbol Digit Modalities Test (SDMT) (range from 0-110) [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    measure of processing speed and attention

  • Number of participants reporting adverse events [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: Yes ]
    The number of participants experiencing adverse events in the active treatment and placebo group will be examined.


Secondary Outcome Measures:
  • Change in EDSS [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    measure of disease severity

  • Change in Beck Depression Inventory -2nd edition (BDI-II) [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Self-report depression scale

  • Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54) [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Quality of life inventory

  • Change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Self-report Fatigue scale


Estimated Enrollment: 158
Study Start Date: February 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caprylic Triglyceride
Caprylic Triglyceride (40 gram packet orally once a day for 90 days)
Dietary Supplement: Caprylic Triglyceride
Caprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.
Other Name: Axona
Placebo Comparator: Placebo
Placebo (40 gram packet orally once a day for 90 days)
Dietary Supplement: Placebo
Placebo (40 gram packet orally once a day for 90 days)

Detailed Description:

Patients with all types of MS (Relapsing Remitting, Secondary Progressive, or Primary Progressive) are eligible to participate. Participants will undergo detailed cognitive assessment before initiating treatment and again after 90 days of treatment, to determine whether Caprylic Triglyceride demonstrates a benefit over placebo.

Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days

Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and objective STOP criteria for efficacy and futility have been defined in the protocol. Final analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Institutional Review Board (IRB)-approved Informed Consent Form signed by patient
  2. A diagnosis of MS as defined by the Revised McDonald criteria.
  3. All subtypes of MS, relapsing and progressive, are eligible.
  4. Males and females age 18 to 59 years old.
  5. Complaints of difficulties with memory or other aspects of cognition.
  6. Mini-Mental Status Exam (MMSE) score >=24 for determination of ability to provide informed consent.
  7. 8th grade English reading proficiency as determined by Wide Range Achievement Test-4th edition-reading .
  8. Females of childbearing potential must have a negative pregnancy test prior to entry into treatment phase and must simultaneously use two forms of effective contraception during the treatment and for one month or one menstrual cycle after discontinuation of the study medication.
  9. All concomitant medication doses must be stable for at least 30 days prior to randomization and remain stable for the study duration.
  10. An Expanded Disability Status Scale (EDSS) score of at least a 2.0 with a Functional System Score of at least a 2 in the Cerebral section due to decreased mentation.
  11. Stable neurologic function with no multiple sclerosis relapses for at least 30 days prior to study entry.
  12. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screen.
  13. Documented memory deficit as defined by a score at least 0.5 standard deviations (SD) below age- and gender-based normative values on the Total Learning Score of the CVLT-II OR a documented processing speed deficit as defined by a score of at least 1.0 SD below normative values on the SDMT.

Exclusion Criteria:

  1. Any condition that would render the patient or the caregiver unsuitable for the study, or place them at substantial risk of adverse outcome.
  2. Unwillingness/inability of the patient to fulfill the study requirements.
  3. Evidence of major depression or a score on the BDI-II > or = 30 OR a score < 30 on BDI-II but with endorsed suicidal ideation.
  4. Hypothyroidism
  5. B12 deficiency
  6. Diabetes (Type 1 or 2).
  7. Positive rapid plasma reagin.
  8. Fasting triglyceride level>2 times upper limit of normal value w/in 3 months of Study Visit 1.
  9. History of malignancy of any organ system (other than localized squamous and basal cell carcinoma of the skin), treated or untreated, within the past 2 years.
  10. Clinically significant renal disease or insufficiency.
  11. Clinically significant hepatic disease or insufficiency.
  12. Ethanol consumption greater than an equivalent of 2 oz/20 g/2 units of spirits per day OR 14 oz/140 g/14 units of spirits per week. One oz/10 g/1 unit of spirits = 6 oz/15 g/1 unit of wine = 12 oz/12 g/1 unit of beer.
  13. History of current alcohol or substance abuse.
  14. Known HIV infection.
  15. History of head injury with loss of consciousness > 30 minutes.
  16. History of inflammatory bowel syndrome.
  17. History of severe irritable bowel disease.
  18. History of severe gastroesophageal reflux disease.
  19. History of diverticular disease.
  20. Use of any investigational compound within 30 days prior to screening.
  21. Prior or current use of medium chain triglycerides for medical purposes.
  22. Known allergies to dairy products or soy.
  23. Use of anticholinergic medication within 30 days prior to Study Visit 1.
  24. Use of acetylcholinesterase inhibitors within 30 days prior to Study Visit 1.
  25. Use of memantine within 30 days prior to Study Visit 1.
  26. Use of stimulants within 30 days prior to Study Visit 1
  27. Use of modafinil, amantadine, and dalfampridine within 30 days prior to Study Visit 1, unless the dose has been stable for 90 days prior to Study Visit 1
  28. Use of orlistat within 30 days prior to Study Visit 1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848327

Contacts
Contact: Gloria Rodriguez 305-243-8052 GRodriguez13@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Gloria Rodriguez    305-243-8052    GRodriguez13@med.miami.edu   
Sponsors and Collaborators
University of Miami
National Multiple Sclerosis Society
Accera, Inc.
Investigators
Principal Investigator: Melissa Ortega, M.D. University of Miami
  More Information

No publications provided

Responsible Party: Melissa Ortega, M.D, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01848327     History of Changes
Other Study ID Numbers: 5559072
Study First Received: April 16, 2013
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Cognition
Neuropsychology
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014