Dr. Susan Steen: I have a special interest in dementia and Alzheimer s in related disorders.

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1 Saving Memories With a Shake: The Alzheimer's Drink Susan Steen, MD Susan Steen, MD, a neurologist at South Tampa Memory Center/President, Axiom Clinical Research, talks about a new medical food for Alzheimer's disease. One of the things you focus on is Alzheimer s disease? Dr. Susan Steen: I have a special interest in dementia and Alzheimer s in related disorders. We are talking about Axona today. What is Axona and how does it work? Axona is what we call a medical food. So it s different from a prescription drug and it s different than a supplement. It would require a physician s prescription. A medical food is a substance that has indications for the treatment of a particular disorder, in this case Alzheimer s disease, but it is not a prescription medication. What was is designed to do in Alzheimer s cases? Axona is a compound that we call a medium chain triglyceride. It exists in what we eat but it s a particular medium chain triglyceride that is converted in the liver after it is absorbed through the stomach and something that is called a ketone body. A ketone body then will cross this blood brain barrier and get into the brain. It supplies the brain with energy. It acts like glucose, the ketone body, so it floods the neurons or the brain cells with glucose and gives them a source of energy. Have there been studies that actually show there is an impact with Axona in people that have Alzheimer s? There have been a couple of published studies. Probably the most important one is about one hundred fifty to one hundred fifty two people who had Alzheimer disease who were already on standard of care. So they were on one or two different medications for Alzheimer s disease. The study went on a placebo type trial where half the people got Axona and half the people got a placebo in a blind manner, so nobody knew who was getting what. They looked at cognitive testing for the ninety days. The people that were on Axona remained stable and actually got a little bit better over that ninety day period as opposed to people that were not on the drug or the medication. Who s a good candidate for this kind of treatment? Dr. Susan Steen: In my practice, I see Axona as an add-on medication. We usually get people stabilized on standard of care and now there are four medications that have

2 been approved by the FDA for Alzheimer s disease so we usually start with one, sometimes add a second to that. But somewhere along the line, we offer our patients Axona and really it s any patient with Alzheimer s disease. What have you seen in your patients with Alzheimer s disease when you introduce Axona? Dr. Susan Steen: The families may report there s more attention, there s more energy, there s more of brightness, to the patient or to their loved one. One of the things we need to be aware of with Axona it does have a side effect profile like all things. Over the counter medications, anything. The side effect with this substance is very similar to what we see with other medications with Alzheimer s disease. That s stomach upset and diarrhea so we have kind of have a trick that we use. We go slow when we start, we don t start with a whole dose. We mix it with a high protein drink like Ensure, Boost or something like that. That decreases the side effects significantly. It s a food, they drink it, eat it, and what exactly do they do? It s a powder so they mix it with usually a high protein drink, such as a milkshake or Boost. They drink it after their breakfast. It gives symptomatic effect during the day for about eight hours. Does it work for everyone or just certain patients? Dr. Susan Steen: No, it doesn t work for everybody. There may be genetic predisposition in certain people that test positive for certain type of genetic profile may do better than others. But we don t know what their genetic profile is when we give it to them. Basically, we try it in most folks and see how they do. Is there a period of how long they can take Axona? Dr. Susan Steen: No. So, they could be on Axona for the rest of their lives? Dr. Susan Steen: They could. Could you tell me in a complete thought, is this cure or a substitute for medication? Dr. Susan Steen: No, it is not a cure. There is no cure for Alzheimer s disease at this point. That is why we are very aggressive in clinical research looking for a substance that will stop the progression, maybe prevent Alzheimer s disease. So, there s much research being done in this area. It s a symptomatic treatment to help patient s day to day with their thinking and there alertness.

3 Many people have never heard of Axona, why? Dr. Susan Steen: It s relatively new; it s only been around a couple of years. A lot of doctor s have not even heard of it. I think it s important to let the public know of anything that can help them. Is it controversial? Dr. Susan Steen: I think most of the medications in Alzheimer s disease are controversial because; they are symptomatic. Medicines help for a period of time when patients are on them but; they don t change the course of the disease. Some people feel, why treat? I m not of that camp, I think that we should be aggressive in treating people making their lives as best as they can be. When you look at this option and what it s done for your patients, is it exciting for you at a time when there is still no cure for Alzheimer s disease? Dr. Susan Steen: It doesn t work for everybody. There are some people that have somewhat of a robust response to it. Sometimes it s a response that lasts for several months, maybe longer. It s one of the tools we use, it s part of the combination, part of the cocktail that we use. Everybody s different, I think is should be considered as part of the platform. Do you see family s coming to you stating this has made such a difference? Dr. Susan Steen: Occasionally, I have seen that, yes. Would you tell me about that? Dr. Susan Steen: I have one patient who started reading the newspaper after she started taking the Axona. She was already on the couple of medications and she became more with it, more alert. That was very exciting for her daughter. Are there doctor s who think this is not a medical treatment, this is not a drug, and this is food? Dr. Susan Steen: I think, overall, there are doctors who feel uncomfortable putting people on medications all together in the treatment of Alzheimer s disease. There are some who really don t even go there. I think they would probably feel the same way about this. I never heard anyone say to me, this doesn t work, it s a food, it doesn t make since. People are very interested because it does make sense. I mean, we know when we look at the brains of people with Alzheimer s disease early, early on. There is a decrease in glucose metabolism. We can see that on PET scans, so this theoretically fits the need because it s supplying that kind of over abundance of glucose to the cells that will flood the neuron. Enabling the neuron to work better and help improve the patient s quality of life.

4 This is what it s about, correct? Dr. Susan Steen: That s one of the things it s about. Axona is to help people be as independent as they can be, to be able to do the things they want to do and that they can do. To be able to stay home as long as they can. To help behaviors, there is no data that Axona really helps in behaviors. There s some date in regards to the other medications. There is no cure. It s a day to day, a month to month thing to help these folks as they walk through this journey. Is there anything you would like to add in the contest of this conversation? Dr. Susan Steen: It s a conversation that families should feel comfortable about discussing with their doctor. One of the things that s nice about medications is that in this case there are samples that are available. So individuals can start at no cost to them. It s important for them to know how to take it and start slowly like I stated before. Does Axona take a certain amount of time before it begins to work; or is it immediate? Dr. Susan Steen: It starts to work right away. There was one study that looked at a small group of people that had Alzheimer s disease and metacognitive impairment and they drank the medicine, and they were tested cognitively that same day. They did better, so from day one on a full dose, they should show improvement if they are going to. END OF INTERVIEW

5 This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters. If you would like more information, please contact: Axona (877) Sign up for a free weekly on Medical Breakthroughs called First to Know by clicking here

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