New Aricept Doses Approved by FDA

by Mahesh on July 30, 2010

Eisai and Pfizer announce FDA approval of increased doses of Aricept, their popular acetlycholinesterase inhibitor given to patients with Alzheimer’s disease.

FDA grants approval to 23 mg/day Aricept pill

Aricept (donepezil HCl), is a prescription medicine used  to treat the three stages (mild, moderate and severe) of Alzheimer’s disease. Based on the FDA announcement, patients suffering from mild Alzheimer’s can continue to take the conventional lower dose (up to 10 mg/day), while those suffering from  moderate to severe Alzheimer’s can take the new dose of up to 23 mg/day. Aricept alleviates the symptoms of Alzheimer’s – and (although not proven) there have been some reports of improvement in cognition and behavior.

According to an article in Canadian Business Online, this drug has brought Pfizer $432 million in 2009 and Eisai a huge $3.3 billion, making it the largest seller of the four drugs that can temporarily reduce Alzheimer’s symptoms.

While the struggle to find a more effective treatment for Alzheimer continues, Aricept is Pfizer’s and Eisai’s leading drug in the neurological disease pipeline. Pfizer has been smart enough to maintain Eisai’s alliance on this product, especially after the relationship was in question with the Pfizer-Wyeth merger.

The FDA approval came as a result of a study of 1,467 patients with moderate to severe Alzheimer’s who were tested after both dosage levels (10mg/day and 23 mg/day).  Patients are generally started on a much lower dose of 5 mg/day before ramping up to 10 mg/day after 4-6 weeks. The higher dose of the drug is only available to patients who have been taking Aricept’s lower dose of 10 mg/day for at least 3 months.

Higher dose Aricept could provide more relief to patients

According to the Alzheimer’s Association, approximately 5.3 million Americans suffer from Alzheimer’s disease in the United States. This leads to an annual cost of 172 billion dollars to manage the disease. Although these dose changes do not come with any guarantee, the goal is to provide additional symptomatic relief to patients. In the meantime, we all look forward to future treatments that could promise a better life for those suffering from this disease.

We have reviewed some of the treatment options available to Alzheimer’s patients in a previous post here .

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Immune Response, Alzheimer’s and Aging

by Henry on July 29, 2010

This piece from Discover is a fascinating look into why we age.  It has a direct relation to Alzheimer’s disease:

In recent years, gerontologists have overturned much of the conventional wisdom about getting old. Aging is not the simple result of the passage of time. According to a provocative new view, it is actually something our own bodies create, a side effect of the essential inflammatory system that protects us against infectious disease. As we fight off invaders, we inflict massive collateral damage on ourselves, poisoning our own organs and breaking down our own tissues. We are our own worst enemy….

When you start to think about aging as a consequence of inflammation, as Tracy and many prominent gerontologists now do, you start to see old age in a different, much more hopeful light. If decrepitude is driven by an overactive immune system, then it is treatable. And if many chronic diseases share this underlying cause, they might all be remedied in a similar way. The right anti-inflammatory drug could be a panacea, treating diabetes, dementia, heart disease, and even cancer. Such a wonder drug might allow us to live longer, but more to the point, it would almost surely allow us to live better, increasing the odds that we could all spend our old age feeling like Jim Hammond: healthy, vibrant, and vital. And unlike science fiction visions of an immortality pill, a successful anti-inflammatory treatment could actually happen within our lifetime.

The ‘Tracy’ referred to in the article is Russell Tracy, a professor of pathology and biochemistry at the University of Vermont College of Medicine.  By and large, treating aging in this way is science fictional at the present time, but it shows how research into aging could eventually lead to new Alzheimer’s treatment. The article goes on: “The evidence that inflammation is behind other diseases is indirect, but it is mounting. Researchers have long known that in patients with Alzheimer’s, the areas of the human brain clogged with senility-associated plaques also bristle with inflammatory cells and cytokines.”

In short, Alzheimer’s is potentially an immune response due to aging: “Several years ago some neuroscientists began to suspect that immune cells in the brain, in their efforts to destroy the plaques, might release poisons and inadvertently harm neighboring, healthy brain cells.”

Cure the way the body undergoes this immune response and you’ll have a potential cure for Alzheimer’s. Still, this may not be the smoking gun, as there is some amount of confusion as to why some aging brains develop Alzheimer’s and some do not.

Neuropathological examination can detect occasional individuals in whom the microscopic features typical of late-onset Alzheimer’s disease are present yet a clinical history of dementia is absent. On other occasions, the converse seems true: individuals seriously disabled in life by dementia show at death only mild pathological features of Alzheimer’s disease.

There are many things we clearly do not fully understand. The immune response issue isn’t the whole picture either, and there are cases where people with amyloid plaque build-up do not always develop the disease.  Alzheimer’s disease is a fundamentally complicated disease and  amyloid plaque may be more of a guidepost than a smoking gun for curing it.  There is still a lot to be discovered both about immune response and why this response may trigger Alzheimer’s in some but not others.

Gene Research

Nevertheless, research on aging could be a vital component to finding ways to diagnose and cure Alzheimer’s. Promising genetic research into aging has led to developments in treating AD. A new study released in the July 23rd issue of Cell connects a gene linked to aging and possible Alzheimer’s treatment:

The researchers found that SIRT1 appears to control production of the devastating protein fragments, termed A-beta peptides, that make up amyloid plaques. They also showed that in mice engineered to develop Alzheimer’s plaques and symptoms, learning and memory deficits were improved when SIRT1 was overproduced in the brain, and exacerbated when SIRT1 was deleted.

People worried about developing Alzheimer’s disease aren’t necessarily interested in the proverbial fountain of youth – they just want to find a way to curb the disease, regardless of halting the overall aging process. While “halting the aging process” may sound like a fantastical and impossible idea, research into aging is still a major component of Alzheimer’s disease research. Though a true fountain of youth that extends lifespan many years may come well after the discovery of a cure for Alzheimer’s disease, the research into the former may very well be the thing to spark the latter.

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“SAGE” Test for Dementia Now Available Online

July 28, 2010

“SAGE” is a recently-released self-administered cognitive screening test developed by the Ohio State University Medical Center’s Department of Neurology.  Publicly available to anyone online, the purpose of the SAGE test is to determine the level, if any, of Mild Cognitive Impairment (MCI) or early dementia.  MCI is also known as isolated memory impairment and is [...]

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MIT Study Links Mouse Model to Genetics of Alzheimer’s

July 27, 2010

SIRT1 works at the heart of the generation of amyloid plagues, In Alzheimer’s disease, amyloid plagues are formed when proteins in the brain break down into toxic amyloid peptides. It is this toxic substance that eventually causes the death of brain cells. In the mouse models tested, the presence of SIRT1 produces more sirtuin proteins that break the amyloid peptides down to a harmless form.

The researchers feel that the use of drugs that activate SIRT1 could reduce the production of amyloid peptides and slow down the progression of Alzheimer’s disease in humans. The main challenge then is to get these drugs across the blood-brain barrier. This doesn’t seem to be easy and they will need to leverage their partnership with GSK to explore options for drug delivery systems. With the current developments in treatment options and biomarker-style drug carriers, this technology could potentially find itself in human clinical trials.

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New Guidelines to Diagnose Alzheimer’s Disease

July 23, 2010

New diagnostic guidelines for Alzheimer’s Disease mean that current technology like brain scans would be used for early detection of the disease.

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Anti-amyloid Bapineuzumab may affect Tau levels in CSF

July 22, 2010

New preliminary results from some of the ongoing studies show that bapineuzumab dosage seems to correlate with the amount of tau (amyloid plagues) found in the CSF of Alzheimer’s patients. Bapineuzumab by itself does not target tau, so these results show that it is affecting the system of tau’s generation somehow.

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Bristol Myers Squib Trial Targets Early-Onset Alzheimer’s

July 21, 2010

Bristol Myers Squib (BMS) will test a drug that is expected to treat Alzheimer’s at its very early stages. The drug is BMS-708163 that is targeted towards patients with Prodromal Alzheimer’s Disease (prodromal means early-onset). The study is still recruiting patients. Alzheimer’s disease currently affects about 5.3 million people in the US alone and 30 million people worldwide.

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Pfizer and Eli Lilly Support Avid’s Biomarker Success

July 20, 2010

Avid’s radioactive tracer was tested in human brains obtained from autopsies of Alzheimer’s patients. This was part of a 5-year, $60 million initiative by the National Institute on Aging’s Alzheimer’s Disease Neuroimaging , and the study showed that the tracer was able to “light-up” the locations in the brain affected by Alzheimer’s disease.

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Findings from the 2010 Alzheimer’s Association Conference

July 16, 2010

The Alzheimer’s Association held their annual conference from July 10th to 15th, 2010 in Honolulu. The conference serves as an annual forum for the discussion of new discoveries relating to the cause, diagnosis, treatment and cure of Alzheimer’s disease

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Vitamin E and Alzheimer’s

July 16, 2010

Encouraging news was released this week about the effectiveness of vitamin E on Alzheimer’s disease. At the same time, this news needs to be taken with a grain of salt, as there are many ups and downs when it comes to Alzheimer’s and vitamin research

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