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Published on: July 11, 2014
by My Suncoast:
A new clinical test on Alzheimer’s is being launched at Rush University Medical Center that involves using nasal insulin to fight the disease.
New evidence suggests that an insufficient delivery of insulin in the brain could lead to Alzheimer’s. The name of the new test is SNIFF, the Study of Nasal Insulin to Fight Forgetfulness, and will deliver the nasal insulin directly to the brain through a spray.
Previous short-term trials have shown that nasal insulin plays a role in improving some of the symptoms of Alzheimer’s. Researchers hypothesize that after 12 months of treatment with nasal insulin, participants will improve cognition and memory.
Only half the participants will receive the insulin, while the other half receives a placebo. Neither the participant nor the clinical staff will know who receives the insulin or placebo until the end of the 12 month period.
Dr. Neelum Aggarwal of the Alzheimer’s disease Center at Rush University Medical Center claims insulin plays a vital role, not only in normalizing blood sugar, but also in brain function. “We know with Alzheimer’s disease that somehow sugar is not being utilized in the brain as it should be. If we can figure out a way to deliver this compound easier to people like with a nasal spray, then we can reach many people at the early stages of memory trouble.”
Tell us about the sniff study; it’s very interesting using this little nasal spray for Alzheimer’s.
Dr. Aggarwal: You know, it’s an interesting study because it is dealing with the compound, insulin that many people have heard about or are taking. It’s really one of the first studies that’s not talking about an investigational drug that people areoften not familiar with or understand how it works. Insulin is pretty common. We think about insulin as it relates to diabetes, or with people who have diabetes, and insulin is important in regulating sugar (or the glucose) in your body. The insulin connection that we’re talking about here, has to do with the brain regulation of sugar. The brain utilizes sugar as its energy source and when we think about Alzheimer’s disease we know that somehow the sugar is not being utilized in the brain as well as it should be. One of the things that has been investigated for many years now is the role of insulin.
We also know in Alzheimer’s that the insulin levels are low and that the insulin is not being utilized to clear out or to use up the sugar. That means different areas of the brain may be not receiving the amount of sugar that they should. The specific areas in the brain include the memory centers. Those receptors are not being utilized properly. Sugar is not being taken up and that is where we’re thinking insulin can help. If we can somehow bring back this regulation then maybe we can enhance thinking.
Do you think this will just slow the progression? How do you think it will work?
Dr. Aggarwal: The hope is to slow down the progression of the disease. At present it’s not curable, so any type of treatment that we do, we measure in terms of slowing down symptoms. If we can figure out a way to deliver this compound easily to people, in this case with a nasal spray, then we can reach many people, even at the earliest stages of having memory trouble with ease . If we do that then hopefully we can prevent the disease from really manifesting or showing up later. That’s really the goal.
So why through the nose, why not an oral medication?
Dr. Aggarwal: Very good question. The nose is a very sensitive area and the cells in the nose, those that line the nose can absorb medicines very quickly. The other thing that many people don’t know is that through the nose is a direct connection to the brain. If you give things through the nose it goes right through the blood brain barrier to the brain directly. So you don’t worry about the medicine not getting absorbed right away or maybe being bypassed throughout the body. You actually have a nice fixed dose of medicine being given at a high concentration through the nose going to the brain, which in this case, is where we want it to go.
So what’s the correlation or is there a correlation with diabetes?
Dr. Aggarwal: Here is another great question. Diabetes is on the rise in this country and is a global problem. We know with diabetes that there are changes in thinking and we do know that diabetes is now being identified as a risk factor for Alzheimer’s disease.. If we know that diabetes is causing Alzheimer’s disease or at least a strong link to the development of Alzheimer’s, we may be able to somehow manage our diabetes better so we don’t develop the disease. If you think about it even further, can we prevent a pre-diabetic situation down the road to manage our thinking process? In this study we’re looking at insulin in people who don’t have diabetes to see if giving insulin through the nose can prevent the development of memory issues.
Is there any supporting data for this?
Dr. Aggarwal: Yes there is a lot of supporting data. I’m happy to say there have been some very pivotal trials by Dr. Craft, who is the lead PI on this study, where she’s been looking at insulin for a long time and trying to understand how it works in the brain. She’s done some smaller studies that have led up to this big study and have supported that not only does insulin seem to be helpful in the thinking process of people, but clinically people who had Alzheimer’s disease and received insulin did better with their cognitive testing or did better clinically on how they were able to manage their day-to-day functions.
That’s a big deal. How big of a breakthrough would you say this is for Alzheimer’s?
Dr. Aggarwal: Yes, I think it could be a really big breakthrough because what it’s really doing is trying to heighten the awareness of how a substance like sugar, if it’s utilized properly and through a proper mechanism- insulin – , can help us so that we don’t develop signs and symptoms of cognitive decline, and if not utilized correctly can lead to memory issues. Many people in this country are diabetic and many people are pre-diabetic. We’re always concerned as physicians of those who may develop diabetes down the road. If we learn how to modulate the sugar issue, we will study how sugar interacts with the brain for brain function, then we’ll have a good chance of slowing down the rates of developing dementia which is the ultimate goal.
From other interviews I’ve done in the past with other doctors, one doctor told me it all boils down to sugar and it’s in your diet. So you wonder if that’s where it starts.
Dr. Aggarwal: I’ve been hearing more and more about that from my colleagues.. Again, the brain utilizes sugar as its energy source; it’s the question of how much. Where is it being utilized, do we have excess of sugar and where is it in our diet? We have it everywhere, sugar is in everything. Now the question is, how do we figure out how to utilize it properly and how can we develop compounds that assist with glucose metabolism and glucose utilization.
It’s like the very thing we need is what harms us most.
Dr. Aggarwal: The things that we like, the sweet things and the sodas and colas – that’s what is hurting us.
How is the trial set up and is it a multi-center trial?
Dr. Aggarwal: It’s a multi-center trial and it’s being conducted through The Alzheimer’s Disease Cooperative Study Group (ADCS). Many centers across the country are starting this trialWhat we’re doing is asking people who have either a a diagnosis of Alzheimer’s disease or MCI (mild cognitive impairment) issues that are concerning for them about their memory to come for screening. They cannot be diabetic. Then we will put them through screening procedure to see if they fit the criteria. If they do then they will be baselined. At the time of the baselining we’ll also show them how to use the device. Again, it’s a nasal device and the idea here is to be easy to use. We want to be able to deliver a medicine that’s easy for someone to take. It’ll be a year and a half -long study
What are the changes in thinking, memory and physical functioning? We’re going to measure all those things with people and there’s a lot of excitement around this study because of all the things that we’re measuring.
How do you diagnose the mild cognitive impairment, it’s kind of hard to diagnose Alzheimer’s disease or really know until a person passes, right?
Dr. Aggarwal: Yes, this is a challenge we’re having right now in diagnosing MCI. For neurologists and geriatricians who are in the field, we have diagnostic criteria in our minds that we know and we’ve used. Essentially, MCI means that there are some mild memory issues that you can see on cognitive testing, but people are doing well in other areas of their lives. Activities of daily living are being done with no issues.
So it’s currently recruiting then?
Dr. Aggarwal: Yes, this study has gone through the preliminary studies and is recruiting.
So who’s the study for?
Dr. Aggarwal: Well the study is for people 55 years and older who have either Amnestic MCI or early Alzheimer’s disease. We make the distinction with MCI as having issues with memory, but everything else is okay. There are no issues with any other ADL functioning and other areas of thinking are fine. The early stages of Alzheimer’s disease are sometimes hard to diagnose but often their memory is impaired and there’s some issues and other areas also start to show signs of changes. But for the most part people are doing very well. We’re trying to combine both of these two groups, the earliest stages with only memory and the early stage of Alzheimer’s. I think you know that is helpful for recruitment so a lot of the doctors will be more familiar with early Alzheimer’s disease than MCI. A lot of neurologists, geriatricians and some internal medicine physicians are utilizing MCI now when they think about their patients, but this study is trying to bring in both groups. It’s a study through the ADCS and we expect to have recruitment continue until we basically reach our numbers of what we need, to really to make a good data observations and if this is really the correct treatment to slow down MCI and early AD. The concern about MCI is that it can develop into Alzheimer’s disease. If we can see people at this stage of the disease and treat them early on then we have a good shot of delaying the presentation of Alzheimer’s disease.
Basically when they’ve looked at folks who passed away from Alzheimer’s and they are looking at their brains, they are noticing that they are lacking. Is that for a better term, they’re lacking the right levels of insulin?
Dr. Aggarwal: Right, the term insulin resistance is exactly as it sounds. It’s that the insulin may be there but there is resistant to picking up the sugar. The sugar is not being utilized properly, or there’s not enough of it. When you look at brains of people, especially those who you know have Alzheimer’s disease you see specific areas of the brain that are not utilizing the sugar the way they should and that has to do with the insulin receptors not being activated.. Those areas of the brain are the hippocampus areas where we process memory quite a bit. There are quite a few areas in the brain that have these insulin receptors that are not working properly. If you were to study them you’ll see that there’ll be less than you would expect or that they’re the ones not functioning properly. We also know that insulin protects against the toxic effect of amyloid protein Did her work, did it show any evidence of reversing?
Dr. Aggarwal: When the initial work was done it was in small periods of time ( over 4 months) . This study is building on that to expand the length of time, that’s why we’re going to a year and a half. Sometimes when we do studies for three or four months seeing reversal is going to be tough. This trial is now going to try to demonstrate over a years’ time if we are seeing changes and if they are lasting more than a couple of months. We’ll have to wait and see, that’s the main thing right now.
Dr. Aggarwal: The goal would be for a reversal to occur, so that we could not only keep the utilization of sugar up but that we could also slow down any signs of deterioration that were starting to show. If you ask people how is your memory and what do you think about your memory? You’d be surprised how many people will really say that it’s not the way it used to be or it’s changing. They don’t know if they should be worried if the doctor is not sure that there is a problem. I think this kind of research that we’re doing is helpful for everybody. It brings AD to the forefront of the mind. People should think about this, how are you doing with regards to your memory and if you are not doing as well as you were before, what could you do to take part in a study to see if we can slow things down?.
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