National MS Society Partners with the University of Miami and Accera, Inc. to Test Novel “Medical Fo - National Multiple Sclerosis Society

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National MS Society Partners with the University of Miami and Accera, Inc. to Test Novel “Medical Food” for MS Cognitive Impairment

April 11, 2013

The National MS Society’s Fast Forward drug development subsidiary is partnering with Accera, Inc., and the University of Miami’s Miller School of Medicine in a clinical trial to determine potential benefits  of Accera’s medical food, Axona® (caprylic triglyceride),  on cognitive impairment in people with MS. Funding to test this novel dietary approach to a troubling MS symptom provides University of Miami with funding over a 36-month period, and like other Fast Forward research partnerships, payments will be contingent upon the completion of specific milestones achieved during the trial.

Novel Approach: Axona is an FDA-regulated “medical food.” Axona has been approved by the FDA for management of biological processes associated with mild to moderate Alzheimer’s disease.  As a medical food, Axona is intended to be used under physician supervision. It has not been approved by the FDA for use in MS.

Cognitive problems are a common symptom in individuals with MS and may have a negative impact on relationships, work, and quality of life. Treatment options are limited. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose may not be converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Axona may work to bypass this problem by providing an alternative energy source that is processed in the liver and used by the brain. This placebo-controlled study will be conducted by researchers at the University of Miami MS Center and will enroll 158 people with MS to determine whether Axona can help restore cognitive function to people with MS.

Researchers are recruiting trial participants in the local South Florida area who have MS and have experienced cognitive changes. For more information or to schedule a screening visit, contact the research Coordinator, Gloria Rodriguez at 305-243-8052 or by email at GRodriguez13@med.miami.edu.

Frequently Asked Questions About the Axona Trial

Who can participate in the trial?
People with any type of multiple sclerosis between the ages of 18-59, who have experienced any cognitive changes, may be eligible to participate.

How many people will participate in the study?
This study will enroll 158 people with MS who have experienced cognitive problems.

How long will the trial last?
The study will be open to enrollment for about two and a half years.  Each participant will be enrolled in the study and receive either placebo or active treatment (Axona) for 90 days.

How many study visits are required?
Each participant is asked to come for three study visits.  The screening visit is about 11/2 hours and the other two visits will take between 2-3 hours.

Do all participants get Axona?
This is a randomized double blind placebo controlled study.  Half of the participants will be given Axona and half will be given placebo.

How is the study being funded?
The project is being funded by Fast Forward, LLC, a nonprofit organization established by the National Multiple Sclerosis Society.

Is Caprylic Triglyceride effective?
In clinical trials, Caprylic Triglyceride has been shown to improve cognitive function in certain people with mild to moderate Alzheimer’s disease.  Caprylic Triglyceride has never been studied in MS patients.  This trial will begin to answer that question for patients with MS.

Are there any dietary restrictions for the study?
Anyone allergic to milk or soy cannot take Axona.  Axona does not contain gluten and only very low levels of lactose.

How is Caprylic Triglyceride administered?
Axona comes as a vanilla-flavored powder that is usually mixed with 4 to 8 ounces of a liquid of one’s choice, preferably after a meal. The placebo formulation will be appear and taste identical to active treatment.  Detailed instructions on how to take the treatment will be provided to participants.

Are there any side effects?
Overall, Caprylic Triglyceride was well tolerated in clinical trials. The most common side effects were diarrhea, nausea, flatulence (gas), and stomach discomfort, which were generally considered mild to moderate. These side effects may be reduced if Caprylic Triglyceride is taken shortly after a meal. If you enroll in the study, the study doctors will provide instructions for taking the treatment and tips for reducing possible side effects.

How do I enroll?
For more information, or to schedule a screening visit, please contact the research Coordinator, Gloria Rodriguez at 305-243-8052 or by email at GRodriguez13@med.miami.edu.

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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