A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsing Remitting MS
- Sponsor
- University of Miami
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Leticia Tornes
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Institutional Review Board (IRB)-approved Informed Consent Form signed by patient
- •A diagnosis of MS as defined by the Revised McDonald criteria.
- •All subtypes of MS, relapsing and progressive, are eligible.
- •Males and females age 18 to 59 years old.
- •Complaints of difficulties with memory or other aspects of cognition.
- •Mini-Mental Status Exam (MMSE) score \>=24 for determination of ability to provide informed consent.
- •8th grade English reading proficiency as determined by Wide Range Achievement Test-4th edition-reading .
- •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.
- •All concomitant medication doses must be stable for at least 30 days prior to randomization and remain stable for the study duration.
- •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.
Exclusion Criteria
- •Any condition that would render the patient or the caregiver unsuitable for the study, or place them at substantial risk of adverse outcome.
- •Unwillingness/inability of the patient to fulfill the study requirements.
- •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.
- •Hypothyroidism
- •B12 deficiency
- •Diabetes (Type 1 or 2).
- •Positive rapid plasma reagin.
- •Fasting triglyceride level\>2 times upper limit of normal value w/in 3 months of Study Visit
- •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.
- •Clinically significant renal disease or insufficiency.
Outcomes
Primary Outcomes
Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
Time Frame: Baseline and 90 days
measure of processing speed and attention
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
measure of verbal learning and memory
Number of participants reporting adverse events
Time Frame: Baseline and 90 days
The number of participants experiencing adverse events in the active treatment and placebo group will be examined.
Secondary Outcomes
- Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54)(Baseline and 90 days)
- Change in Modified Fatigue Impact Scale (MFIS)(Baseline and 90 days)
- Change in EDSS(Baseline and 90 days)
- Change in Beck Depression Inventory -2nd edition (BDI-II)(Baseline and 90 days)