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Nasal Spray For Alzheimer's

Nasal Spray For Alzheimer's

CREATED Jul 23, 2014

CHICAGO (Ivanhoe Newswire) - Every 70 seconds, someone in the U.S. develops Alzheimer’s disease. There is no cure, but there is new hope.

From July 12-17, the greatest minds in Alzheimer’s research gathered in Copenhagen, Denmark discussing the latest breakthroughs and developments in this disease. Breakthroughs that bring people like the Jolie’s hope.

Judy Jolie knew back in college her husband Tom was the one.

“Right away we knew we wanted to do something with our lives,” she said.

Tom felt the same.

“We realized we had a lot of things in common and I think that’s what basically attracted us,” he said.

The two married and began their life together on a mission trip to South America. Now, 50 years later, Jolie fondly remembers those times, but after being diagnosed with Alzheimer’s disease eight years ago, her short term memory is fading.

“Some people can’t walk very well or run and I just you know, can’t hang onto you know, I can’t pull things out of my memory as well as I’d like to,” Jolie told Ivanhoe.

The trial, known as “SNIFF” is testing a new insulin nasal spray that could change the way we treat Alzheimer’s, and could give Jolie new hope.

Insulin plays a vital role in managing your body’s blood sugar. Neelum Aggarwal, MD, Cognitive Neurologist at Rush University Medical Center said it also plays a key role in brain function.

“If you have Alzheimer’s disease, you see specific areas of the brain that are not utilizing the sugar the way they should. That has to do with the insulin receptors,” Dr. Aggarwal told Ivanhoe, “These areas of the brain now are not working.”

That insulin resistance impacts memory and the spray will deliver insulin directly to the brain where changes can take place.

“So if we learn how to modulate the sugar issue and learn how sugar interacts with the brain for brain function, then we have a chance of slowing down the rates of dementia which is our ultimate goal.” Aggarwal said.

In a smaller trial, the spray was shown to improve memory and preserve cognitive function in the early stages of Alzheimer’s. Results the Jolie’s would be thrilled with.

The sniff study is actively recruiting patients across the country in 29 centers. Qualified patients are non-diabetic and have been diagnosed with mild cognitive impairment or are in the early stages of Alzheimer’s disease.

For more information on how you can get involved in the study, log onto: www.adcs.org/studies.

RESEARCH SUMMARY

ALZHEIMER’S: Alzheimer’s disease is the most common form of dementia (accounts for 50-80% of dementia cases) that causes problems with thinking, memory and behavior. Alzheimer’s slowly breaks down brain cells. As it spreads, more cells lose their ability to function and eventually die, causing significant damage to the brain. According to the National Institute of Aging, more than 5.3 million people in the U.S. suffer from Alzheimer’s. The disease mostly affects people over the ages of 65. According to Angela Geiger, chief strategy officer of the Alzheimer’s Association, “Alzheimer’s is still largely misunderstood. Everyone is at risk for Alzheimer’s, with age being the biggest factor.” In 2014, the Alzheimer’s Association held their international conference from July 12-15 in Copenhagen, Denmark. (Source: www.alz.org, www.alz.org/aaic)

NEW TECHNOLOGY: 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. (Source: www.archneur.jamanetwork.com)

DR. NEELUM AGGARWAL: 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.” (Source: Dr. Neelum Aggarwal)

INTERVIEW

Neelum T. Aggarwal, M.D., Cognitive Neurologist, Clinical Core Co-Leader, Rush Alzheimer’s Disease Center, Rush University Medical Center talks about a new trial that is testing a new insulin nasal spray that could change the way we treat Alzheimer’s.

Can you talk about the scope of the problem with Alzheimer’s?

Dr. Aggarwal: Alzheimer’s disease is a national epidemic. It is a progressive disorder that initially begins with memory issues and forgetfulness but then it eventually involves other areas of thinking, such as difficulty with language perception, judgment or attention. Right now, we know that atleast 5.4 million people in the U.S. have the disease. There are countless others that have not been diagnosed with the disease. In addition, there are many other people that are worried that they are going to develop the disease and it is becoming such a prevalent issue. Many are worried about developing the disease or know someone who has the disease. .

I read a statistic that said they think the figures are going to triple by 2050.

Dr. Aggarwal: Yes, exactly. Whenever you read those figures, keep in mind that’s with the data that we have. There are many people out in the community who don’t even know they have the disease, have never mentioned anything to their doctor about concerns or shared issues about memory. The doctors may have never seen them to diagnose it, so those numbers are an underestimation. In addition, Alzheimer's is not only a U.S. disease but also a global issue. Across the world we are seeing increased rates of Alzheimer’s disease.

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?.

So the images you have are actually with the sugar?

Dr. Aggarwal: Yes, the images I’m pulling up are PET images where you can see that there is decreased glucose utilization in the brain. Those are important images because the earliest studies were showing that after taking the nasal insulin, areas that were not taking glucose before perked up or lit up on the scan and started using it again. That led to the thinking that there was a dysregulation of the glucose in the receptor and that led to the larger study.: We’re very hopeful with this study that we’re going to show some measurable changes and check people for not only on the brain scans but check their spinal fluid to see if we can see any biomarker changes. Also, Alzheimer’s is coming into the classification as a woman’s disease which means more women are developing Alzheimer’s disease than men and as women physicians we’re talking about it as a Woman’s disease. When you think about a disease affecting women we we not only think about an older woman, but also a disease affecting a mother, grandmother, a bread winner, or perhaps the head of a household.

In addition, in all of these types of studies or treatments, we are beginning to look at the sex and gender differences. In this study for example, we can look at whether there are differences between men and women in their response to the nasal insulin, their response clinically and their response cognitively. I think that’s another area that clinical trials are going into more, examining the sex and gender difference.or if these medicines work differently.

Why is it that women may be developing Alzheimer’s disease more than men? The biggest theory or at least the biggest belief is that women live longer than men so as you live longer you have more opportunity or risk to develop the disease. We also know that the brains are different in men and women. That’s one thing to keep in mind when you hear about these trials and what’s happening. How are things differently metabolized? What are the brains looking like? Are they different with regard to receptors in the brain for certain medications or not. This is an area up and coming, a lot of work is going in this area and it’s really exciting.

It’s pretty fascinating actually to think about the real differences in our bodies.

Dr. Aggarwal: Yes, sex and gender differences in medicine is an exciting area. .

Were there any stats that have come out that showed a certain percentage of improvement, do you know those numbers perchance?

Dr. Aggarwal: When we think about improvement we think about cognitive testing. What they did better in was word and story recall. They remember details of a story better. They would perform better on memory tests and so we would measure those kinds of tests in a testing situation for people in the study. The other thing that they saw was that clinically they did better.

So those are the two parameters that we really look at when we look at drug studies, is if they help..

Dr. Aggarwal: I think one other thing if I could add. Just a cautionary note, the insulin that we’re talking about in this study is not the same as the insulin used for diabetes. It is a different type of insulin that’s being used, it’s formulated for this and we’re not advocating people to go out on their own and try to take insulin to enhance my memory.

No self-medicating right?

Dr. Aggarwal: Exactly, no self-medicating.

FOR MORE INFORMATION, PLEASE CONTACT:

Neelum T. Aggarwal, MD
Cognitive Neurologist
Rush University Medical Center
Phone: (312) 286-6312
Neelum_t_aggarwal@rush.edu
Neelum8007@gmail.com