Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis

NCT01848327 | Completed DMC

• 2 other identifiers: 201204155559072
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsing Remitting MS; Secondary Progressive MS; Primary Progressive MS

Keywords

Cognition; Neuropsychology; Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80)

  measure of verbal learning and memory

  Baseline and 90 days

• Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)

  measure of processing speed and attention

  Baseline and 90 days

• Number of participants reporting adverse events

  The number of participants experiencing adverse events in the active treatment and placebo group will be examined.

  Baseline and 90 days

Secondary Outcomes (4)

• Change in EDSS

  Baseline and 90 days

• Change in Beck Depression Inventory -2nd edition (BDI-II)

  Baseline and 90 days

• 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

Study Arms (2)

Caprylic Triglyceride

EXPERIMENTAL

Caprylic Triglyceride (40 gram packet orally once a day for 90 days)

Dietary Supplement: Caprylic Triglyceride

Placebo

PLACEBO COMPARATOR

Placebo (40 gram packet orally once a day for 90 days)

Dietary Supplement: Placebo

Interventions

Caprylic Triglyceride DIETARY_SUPPLEMENT

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.

Also known as: Axona

Caprylic Triglyceride

Placebo DIETARY_SUPPLEMENT

Placebo (40 gram packet orally once a day for 90 days)

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• th 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.
• Stable neurologic function with no multiple sclerosis relapses for at least 30 days prior to study entry.
• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screen.
• 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.

You may not qualify if:

• 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 1.
• 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.
• Clinically significant hepatic disease or insufficiency.
• 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.
• History of current alcohol or substance abuse.
• Known HIV infection.
• History of head injury with loss of consciousness \> 30 minutes.

Sponsors & Collaborators

• University of Miami: lead
• National Multiple Sclerosis Society: collaborator
• Cerecin: collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

tricaprylin; caprylidene

Condition Hierarchy (Ancestors)

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

Study Officials

• Leticia Tornes, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 7, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)