Most people have only a vague understanding of how Alzheimer’s medications get approved by the FDA and come to market where we can get our hands on them. You read about promising medications that are being studied, but you never hear when and if something is going to come out. If Alzheimer’s is in your family, you sure wish they would hurry up, right?
How would you like to know what drugs are currently being tested for Alzheimer’s? How would you like to get your hands on those drugs right now, and not have to wait 5 or 10 years for them?
You should know then, that there is a way to do this without going to the Black Market. Actually, you will be surprised to know that it’s quite easy. In fact, the manufacturers of these new Alzheimer’s medications would love for you to have it. They are at this very moment actively looking for people that want to try these new medications.
The method for gaining access to these medications is ‘drug trials’ and they’re going on all the time, and you are about to learn how to find them and how to get into them. But first let me give you at least a basic understanding of the process.
When you talk about drug trials people respond in one of two ways. One groups shudders at the very thought of a drug trial; picturing themselves as proverbial guinea pigs, being fed toxic cocktails of chemicals that will cause them painful and crippling side effects and death. While the other group is practically leaping out of their chairs, hands raised to volunteer for what they believe is the best and finest medications that advanced scientific research has discovered; research based on the accumulated efforts of dozens of Universities and private laboratories. They reason that the minuscule risk is outweighed by the much more likely outcome that they or their loved one will get badly needed relief from a disease or condition that is carving away at their health and vitality.
Sounds pretty dramatic huh? Well, you get the point. People either think you are nuts to take an experimental drug or they are grasping at their last hope. You rarely find anyone on the fence about it.
But for these fence sitters, I am obliged to explain the drug trial process the best I can, because this article ends with a resource that you can use to find drug trials near you. Not just for Alzheimer’s disease, but for any condition or illness that concerns you.
First let’s look at a few of the advantages of participating in a drug trial:
* Free medication – when approved it will be very expensive. (For everyone else)
* Better yet… you get paid to participate. (both the caregiver and the patient)
* Lots of expensive examinations and medical tests for free. (seriously, you get a full workup worth thousands of dollars)
* Afterwards you get to continue with the medication indefinitely. (It’s called a follow up study and even if you were in the placebo group, you get the medication for as long as you like)
* A very good chance at symptomatic relief, if not a reversal of the condition altogether. (would they be doing this test if they did not already have a lot of promising results?)
* Hope. Never underestimate the power of hope and positive thinking.
But wait, what about all that stuff about guinea pigs, concoctions, and risky side effects? Well let’s look at the process of drug trials and FDA approval.
The heart of drug trial research is the “double-blind study” This is the only accepted method of research for the FDA.
A double-blind study is the FDA’s insurance that the results of any research is truly due to the effects of the drug, and not the opinion of the researchers that stand to make a lot of money. Nor the test subject’s psychosomatic wishful thinking that the drug did its job.
Here’s how it works; you have at least two groups of subjects, one group is getting the ‘test’ medication, and another group is getting a lookalike (a placebo), and then they check to see if there is a statistical improvement between the two groups. (Nowadays, placebos are much more than just a sugar pill. Typically they give both groups the exact same treatment, except one has the active ingredient and the other doesn’t). The researchers that are working directly with the patients do not know which treatment group is getting the active ingredient, they are ‘blind’. The patients are also ‘blind’, they don’t know if they are getting the active ingredient or not. Presto; you have a double-blind study. The reason this works so well is, scientists have learned over the years that even unbiased researchers will often think they see improvements, thus distorting the results. Then there is this strange phenomenon called the ‘treatment effect’; on average a certain percentage of test subjects improve even on the placebos. Interestingly the percentage of subjects improving is very consistent. If I recall correctly, it is around 12%. Double-blind studies eliminate the treatment effect because both groups will average the same treatment effect and cancel it out as a factor.
But you don’t want all this technical stuff, do you? Let’s get back on point. Drug studies have 4 phases they go through before they are approved by the FDA. Phases 3 and 4 are with groups of people. Phase 3 is usually the first time the drug is tried on the public, and they keep the size of the study very small. If all goes well in Phase 3, then they move to Phase 4, using a much large group of people. If you are interested in drug trials, you will almost invariably be involved in a Phase 4 study.
Getting into a drug study is a lot easier than you would imagine. All over the country there are Universities and private testing labs that are turning down drug studies because they can’t find enough participants. So don’t feel like you will be put onto a waiting list. Just be aware that these studies do have certain criteria that has to met.
Which brings us to, “how DO you get involved in a study?” That’s the problem, there are several websites dedicated to providing information about the drug studies, but none of them seem to do a very good job. You can get a list of these sites at the following website: http://alzheimersecrets.com/drugtrial/. However, you may decide to not use them because this site synthesizes all of the information for you. Not only that, but you can actually make a direct inquiry for your location and for the condition or disease you want to address with them. And remember, you can approach any of these sites for any illness or condition, not just Alzheimer’s. Now let’s get into the drugs themselves.
Current Alzheimer Research
This one is getting all the “Press” right now, it seems everybody knows about it and so far it has promising results. Used as an antihistamine in Russia for many years, it also protects against brain cell death. Dimebon targets mitochondria (the cell’s power generator). Phase 3 results show significant improvement in all the key aspects of Alzheimer’s, including thinking, memory, behavior and overall function. Results have been published in “Lancet” July 2008 (Lancet in England is the equivalent of the New England Journal of Medicine in the U.S.). Rumor is Dimebon may be on the market as soon as next year.
Rember (Methylthioninium chloride)
Early research is promising, as researchers announced that the compound appears to slow and even halt the progress of Alzheimer’s. It does this by dissolving tangles of tau protein inside brain cells and preventing their accumulation, stabilizing the disease progression in patients with mild and moderate Alzheimer’s over a period of one year. Over a longer period of 19 months, researchers saw an 81% slowing of the disease. Rember may be on the market as early as 2012.
This drug, like Rember, also addresses the problem of neurofibrillary tangles, also interfering with the formation of tangles by affecting the tau protein. However, this drug is administered as a nasal spray. Which brings up a rarely discussed aspect of drug trials: not all drug trials involve taking a pill! Some are nasal sprays, eye drops, some are even administered intravenously. The good news is results with AL-108 took far less time than Rember. Researchers reported a 62.4% improvement in memory with no side effects in only 4 months time.
Lupron (Leuprolide, Memryte)
Don’t you just love the way they name these drugs? Memryte (memory right?) or Rember (Remember?). Lupron is currently an approved drug for the treatment of advanced prostate cancer. But now they are looking at it for Alzheimer’s because it alters production of beta-amyloid in the brain. Beta-amyloid, in a nutshell, is the main material that plaques are made of. The theory is, no beta-amyloid = no plaques = no Alzheimer’s Disease.
Funny story: the connection between Lupron and Alzheimer’s was discovered accidentally, when the wife of a metastatic cancer patient who was receiving Lupron told the doctor that the drug worked well on his cancer – and his Alzheimer’s appeared to improve, too. (Wow, a doctor that listens! What a concept)
Basically these are antibodies already in our blood. These antibodies are used by our immune system to hunt down and eliminate bacteria. This is one of those treatments that is being administered intravenously. It is still in the early stages of research, and larger studies are forming as you read this.
One of the little know facts about drug approval by the FDA is that Pharmaceutical companies spend 10’s of millions of dollars bringing a drug to market. Therefore it’s safe to assume they have to be pretty confident of success before they decide to start a new drug trial. Furthermore, you can imagine that the process is complicated and technical. Let me give you an example, when they apply for a new drug approval, they have to be very specific about which disease, or condition they are going to test for. That makes sense. But occasionally after a drug comes to market it may start showing effectiveness on conditions that it was not originally intended for. But if they want doctors to legitimately prescribe their established medication for this new condition they have to start the drug trial process all over again from scratch.
Thus is the case with Lupon mentioned above (currently approved for prostrate cancer), as well as this one Avandia. Avandia is currently on the market for type 2 diabetes, in diabetics it enables their cells to use the hormone insulin more efficiently. But they now think it might affect the brain inflammation seen in Alzheimer’s patients, so they are starting new drug trials for it.
“Another method for targeting Alzheimer’s comes in the form of a vaccine that uses antibodies from the body’s own immune system to attack and destroy beta-amyloid and clear out plaques in the brain, or to eliminate clumps of tau protein (neurofibrillary tangles) in the brain that kill neurons responsible for memory”. Phase 3 studies are also starting this year, and they look promising. * (Oops, hold that thought, just yesterday as I was finishing this article there was story making the rounds that a prominent research physician was quoted in the press as saying that he has serious doubts that beta-amyloid is the cause of Alzheimer’s and that researchers are missing the boat, and spending a lot of time and money for nothing. Time will tell…)
This is another of those methods that have been around, getting perfected for years. It is very complicated, and involves genetically altering your own cells to produce nerve growth factor (NGF) and injecting these altered cells into the brain to slow the destruction of brain cells. They may sound creepy, but naturally produced NGF has amazing promise for many different illness and diseases. Some researchers are predicting extending the life span by decades when NGF is perfected.
Histone deacetylase (HDAC) inhibitor
Researchers are making impressive claims with this one. “This compound has the potential not only to slow degenerative memory loss, but also to reverse the process and bring back lost memories”. The HDAC inhibitor compound was first formulated at the Massachusetts Institute of Technology (MIT). “The research suggests that people with dementia might not completely lose their memories, but that the memories might be stored away somewhere that is inaccessible. The clinical trials are expected to assess whether ADAC inhibitors can safely and effectively improve cognitions and possibly reverse memory loss in humans.
This concludes the long list of drug trials that are out there for Alzheimer’s Disease. Can you imagine…this is just Alzheimer’s? I have heard of studies for just about every other major disease, and even for conditions that I did not know were a problem. For example I read about a study that was supposed to make eye-lashes grow longer and thicker. I don’t see anyone dieing of thinning eye-lashes, but I certainly see where something like that would make a fortune.
Nevertheless, if you or someone you know is interested in drug trials please go to this site for a complete list of different websites that promote and talk about drug trials: http://alzheimersecrets.com/drugtrial/.
Source: Special Report on: Combating Memory Loss (common problems and treatments) by Massachusetts General Hospital & the editors of Mind, Mood & Memory.