Clinical trial NCT01848327: Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis
Official title: A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing Remitting MS
Secondary Progressive MS
Primary Progressive MS
Keywords: Cognition
Neuropsychology
Multiple Sclerosis
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Cerecin
First posted: 2013-05-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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.

Primary outcomes:
measure: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80)
timeFrame: Baseline and 90 days
measure: Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
timeFrame: Baseline and 90 days
measure: Number of participants reporting adverse events
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Change in EDSS
timeFrame: Baseline and 90 days
measure: Change in Beck Depression Inventory -2nd edition (BDI-II)
timeFrame: Baseline and 90 days
measure: Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54)
timeFrame: Baseline and 90 days
measure: Change in Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Leticia Tornes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: