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Monday, July 1, 2013

A Double-Blind, Randomized, Placebo-Controlled Study of Axona for Cognitive Impairment in Patients with MS

A Double-Blind, Randomized, Placebo-Controlled Study of Axona for Cognitive Impairment in Patients with MS
Primary Investigators: Melissa R. Ortega, MD, Heather Katzen, PhD. University of Miami in collaboration with Accera, Inc.
Cognitive problems are a common symptom in individuals with MS. Treatment options are limited, and there is a pressing need for new interventions to treat MS-related cognitive impairment. Investigators at the University of Miami in conjunction with Accera, Inc. are currently testing a unique strategy for treating cognitive dysfunction in individuals with MS. This research study will examine the safety, tolerability, and efficacy of Axona in MS. Axona, manufactured by Accera, is a prescription medical food that has been shown to improve memory in patients with mild to moderate Alzheimer’s disease. Axona is made from special fats (caprylic triglyceride), which the body breaks down into substances called “ketone bodies,” and these ketone bodies can provide an alternative energy source for brain cells. This alternative energy source may replace the failing metabolism of glucose in the brain, which research shows may be linked to cognitive decline in MS patients.

This double-blind randomized placebo-controlled study is being be conducted by Drs. Melissa Ortega and Heather Katzen at the University of Miami MS Center. The study will enroll 158 MS patients over the next 3 years and is funded by Fast Forward, LLC, a nonprofit organization established by the National Multiple Sclerosis Society. Patients between the ages of 18 and 59 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 Axona demonstrates a benefit over placebo.

For more information, please contact the study coordinator, Gloria Rodriguez at 305-243-8052.
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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

READ more of this study - that is taking place at the University of Miami - by clicking here


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