Medical Foods

Medical Foods and Alzheimer's

Medical foods are foods that are formulated to manage diseases with distinct dietary requirements. According to the FDA, medical foods are intended to be used under medical supervision and they are intended only for patients receiving active and ongoing medical supervision. However, medical foods are not regulated by the FDA as a drug and are not required to undergo the same level of testing as prescription drugs. In addition, medical foods are exempt from the labeling requirements of health claims and nutritional labeling requirements, but they are required to label ingredients. In the EU, regulations, for the most part, are similar.1

Axona and Alzheimer's

Axona was marketed as a medical food to treat Alzheimer’s, however in 2013 the FDA sent the company selling Axona a warning letter because the Axona did not meet the criteria needed to be labeled as a medical food and was therefore an unapproved drug. Axona was a medium chain triglyceride (MCT). MCT were discussed previously and it was mentioned that MCTs do not improve outcomes for Apoe4 carriers. This was also found to be the case for a randomized clinical trial using Axona. In addition, the company that sold Axona tried to get FDA drug approval for a similar product called AC-1204, also a MCT. Unfortunately, the product did not show efficacy in a phase III randomized clinical trial.2,3,4

Souvenaid and Alzheimer's

Souvenaid is another medical food specific for Alzheimer’s. Souvenaid contains docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), uridine monophosphate, choline, vitamins B12, B6, C, E, folic acid, phospholipids and selenium. The manufacturer of Souvenaid collectively calls the above list of nutrients, “Fortasyn Connect”. Prior to 2017, a series of randomized clinical trials were conducted in patients with Alzheimer’s with mixed results. Improvements were seen in patients with mild Alzheimer’s but add not in patients with mild-to-moderate Alzheimer’s. Based on those results a group tested Souvenaid at the earliest stages of Alzheimer’s disease. The 24 month study showed no improvements, but when the study was extended for 36 months significant improvements were seen. On various cognitive tests, the Souvenaid treatment group scored between 45% and 76% better. Reductions in brain atrophy was also found. These results indicate the long-term use of Souvenaid may be beneficial, but it should be noted that the incidence of dementia and the time to make a dementia diagnosis did not differ between the treatment group and the control group.5,6,7,8

In addition, about half of the subjects did not wish to continue on from the 24 month study to the 36 month extended study which could have added bias into the study. For example, maybe subjects that felt a positive effect decided to continue while those that did not have any positive effects did not participate in the extension. Or maybe conditions deteriorated in some subjects and therefore they did not want to continue with the extension with the assumption that the treatment was not effective. In fact, the subjects in both the control group and treatment group that chose to stay on the study extension had a higher cognitive score than the average score of the original participants implying that there was some unintended selection taking place. The average MMSE scores for the original treatment group was 26.4 versus 27.2 for the treatment group in the extension (remember, a MMSE score of 24 is normal). In addition, funding of the study after 24 month was provided by the manufacture of Souvenaid and distributed to researchers to conduct the study. Despite the bias that may have occurred in the study, the majority if not all of the vitamins and nutrients in Souvenaid are critical for cognitive health and a deficiency of those nutrients and vitamins would be expected to have a negative effect on cognition.5,6,7,8

Currently Souvenaid is not for sale within the United States as the required efficacy and safety trials have not been conducted. A phase II trial is being conducted by the University of Miami and results should be available in 2022. Souvenaid’s availability is limited in other countries as well.9