Pharma company Eli Lilly recently scrapped further development of an anti-Alzheimer drug designed to fight the disease from the plaque mechanism; its compound would inhibit the enzyme responsible for catalyzing the process in forming the amyloid plaques pathognomonic for the disorder.

Their reasoning? That the enzyme also works on the formation of other proteins in the brain that have no consequence in the natural histopathological history of the disease. Scientists working on the R&D for this drug have also gone as far as to question this hypothesis as a valid point of research into anti-Alzheimer development. The implications of these second thoughts have yet to be fully realized, but there could be an immediate effect on other Pharma companies researching similar treatments for degenerative dementia should they decide to follow like concerns. | LINK

As Doctor Pundit has always reported in this space, the driver of current Alzheimer disease research has been via biomarkers — the naturally occurring by-products (in this case, abnormal proteins found as the disorder shows initial symptoms and develops) of the body’s normal physiological processes in any organ system. In this case, the system studied is the body’s omniscient powerhouse, the central nervous system. The latest game-changing news is what can be gleaned via the cerebrospinal fluid obtained from within the spinal cord.

Researchers report that a spinal fluid test can be 100 percent accurate in identifying patients with significant memory loss who are on their way to developing Alzheimer’s disease. [...] A lot of work lies ahead, researchers say — making sure the tests are reliable if they are used in doctors’ offices, making sure the research findings hold up in real-life situations, getting doctors and patients comfortable with the notion of spinal taps, the method used to get spinal fluid.

The invasive nature of the spinal tap is a barrier, but the overarching point here is that biomarker research is gaining ground and setting the stage for extremely targeted therapies. All of this talk — even in the past 2 to 3 years — has largely been conjecture. At least until now. Exciting news. | LINK

Research into better treatments and possible cures of Alzheimer dementia is one of the bright spots in the potential for better healthcare delivery in the decade of the 2010s. There are many signs that bode well for the approach to this disorder at the dawn of the second decade of the 21st century.

New research into alternate pathways of disease development is starting to generate excitement among primary care physicians and geriatricians (such as myself) as potential arenas for new classes of drugs to combat Alzheimer’s. Better care delivery models in long term care of the elderly as part of new initiatives in the Affordable Care Act are already starting to impact chronic disease care management strategies.

Perhaps most important, there is new evidence to suggest that earlier detection of this cognitive disorder can enhance those developments, and more. At an annual meeting of top dementia researchers, guidelines were proposed to expand on the research from the ’00s to diagnose the disorder earlier — a strategy that benefits more than just those potentially afflicted with Alzheimer’s.

If the guidelines are adopted in the fall, as expected, some experts predict a two- to threefold increase in the number of people with Alzheimer’s disease. Many more people would be told they probably are on their way to getting it. The Alzheimer’s Association says 5.3 million Americans now have the disease.

Heavier use of newly discovered biomarkers for earlier detection of the pathology behind Alzheimer dementia will be a closely watched process by both physicians and health policy analysts alike. | LINK

Although the prevalence rate of dementia is higher overall in women over 65; this is due to a variety of factors — overall elderly age demographic prevalence, hormonal declines (circulating estrogens), and the presence of certain vascular related disorders, just to name a few. But what about the incidence of dementia in a male spouse as an association for the incidence of dementia in females — both of whom had no signs of the disorder initially?

A trial published in the latest Journal of the American Geriatrics Society shows that over 1000 patients (married couples in a single Utah county) were followed for a period of at least 12 years^[1]. Initially without the diagnosis of Alzheimer dementia, those caregiving wives developed dementia along with their husbands in 30 cases. Although the study did not specifically examine wives as caregivers using explicit criteria, most lived in the same space as the male spouse at the time of diagnosis. An interesting result that should spur more study in the gerontological (social scientific) realm of dementia treatment and incidence in the community. | LINK

1. All married couples were dementia-free at baseline in 1995 and were followed-up for an average of 12.6 years (median follow-up, 3.3 years) to monitor for incident dementia in husbands, wives, or both, according toDiagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised, diagnostic criteria. [↩]

Perhaps the most salient aspect to the hubbub surrounding the reform bill (politics aside) is the tremendous amount of myth surrounding its individual provisions. Of course, no single lobby or advocacy group (mainstream media included) has the desire to read the entire thing — only the portions that benefit their needs, for whatever reason.^[1] However, groups under the radar, such as those which lobby for the needs of the Alzheimer patient population, stand to benefit from the recently passed legislation. According to the VP of the Alzheimer’s Association’s Public Policy and Advocacy Division, Obama’s reform legislation would

[Establish] a Medicare pilot program to provide transitional care to seniors at a high risk, including those with cognitive impairment, of re-entering a hospital. Cognitive impairment due to Alzheimer’s and other causes increases the complexity of care transitions and post-acute care, resulting in increased risk for medication errors and hospital readmissions. Alzheimer families need assistance with planning and managing discharge and post-acute care, including arranging and monitoring in-home medical treatment and supportive services.

It is easy to see the mixture of hope, advocacy, and idealism in this organization’s comments on the possibilities inherent in the reform bill. It’s also apparent how difficult it will be to apply them in the face of other lobbies desirous of the same possibilities and resources Obama’s reform will bring. | LINK

1. The AMA and AARP are perhaps the most well-known examples of lobbies taking public postures on reform. [↩]

Pfizer’s current research on a potential blockbuster anti-Alzheimer drug is currently back to drawing-board status. According to the pharma company

[T]he drug, called Dimebon, had shown virtually no effect after six months in treating the cognitive decline or behavioral problems associated with Alzheimer’s when compared with a placebo.

Apparently, Wall Street has been watching the results of this Phase I study; the verdict is still out on whether Pfizer will continue to fund the research for this agent — designed to work better and longer at inhibiting some of the most distressing symptoms related to the disease. | LINK

• The Wellpoint saga continues…as well as the blame game for significant premium hikes.
• Study: alcohol + energy drinks (like Red Bull) = recipe for disaster.
• Has the H1N1 pandemic peaked?
• The first study of the anti-CSF prototypes for treatment/reversal of Alzheimer dementia is underway.

The trial will measure in the cerebrospinal fluid (CSF) and blood plasma of amnestic mild cognitively impaired (MCI) patients the biochemical changes that are associated with AD and correlate them with the pharmacokinetics of the drug and its metabolites.

• For California, the bleeding never ends. Today, Gov. Schwarzenegger releases his spending plan for 2010-11 which details even deeper cuts to its Dept. of Human Services.

A nationwide clinical trial is underway to determine if a specialized drink is able to improve the neurocognitive deficits seen in Alzheimer dementia (AD). The tested concoction is being evaluated for its ability to provide improvement in the clinical domain of verbal recall. The trial is based upon a European study done in which 225 AD patients were randomized to take the nutritive drink or a placebo. Results were apparently encouraging^[1] enough to U.S. researchers to enroll patients at 40 sites across the U.S. in a double-blinded study. Should be interesting.

I guess you could call it a kind of Boost for dementia.

1. In that study, 225 patients with mild Alzheimer’s were divided into two groups. Some drank Souvenaid and the others sipped a non-medical drink every day for 12 weeks. Researchers found that the patients who drank Souvenaid improved in a delayed verbal recall task. [↩]

The major focus of research into the biochemical causes and manifestations of Alzheimer dementia (AD) has largely been characterized by a rather pinpoint and straightforward course. Relegated to the foundations of disease genesis within the cerebrospinal fluid and in cerebral neurons, discoveries in this facet of AD research have yielded much in the way of prior (development of cholinesterase inhibitors to treat AD symptoms) and future treatments (tau and beta amyloid protein modifiers, etc). The common theme with respect to those discoveries depended heavily on neurons already found to be diseased with the abnormal proteins and the like.

With the recent news of new research techniques involving the role of abnormal proteins in healthy cells, researchers hope to detect the onset of cellular changes responsible for initiating the AD cascade as it is happening, thus opening the potential for new mechanisms of disease and treatment. Although it is exciting to document the genesis of abnormal neuronal signals that may herald the early changes seen in asymptomatic AD patients, it is even more exciting to begin to search for the potential to turn off this mechanism completely. | LINK

In the upcoming NEJM, a large prospective study makes the case for the consideration of dementia as a certain cause of death for the mostly elderly patients who suffer from it. Ever since the disorder was first described by its namesake Alois Alzheimer, MD 102 years ago; it has always been thought of as an unfortunate comorbid “condition” of which advancing age itself was a risk factor. The complexity of the diagnosis made early attempts to formulate effective treatments virtually impossible. Toward the middle of the 20th century the focus of caring for the patient who suffered from dementia shifted to palliation and suppression of other comorbidities which could hasten its clinical effects.

At the end of the last century, breakthroughs in neurobiological research opened the doors to classes of drugs that have largely been successful for controlling debilitating symptoms — without, however, effecting retardation of the disease, or even a cure. Thus the stage was set for a redefinition of sorts for this illness. Authors of the study have delineated the course of dementia (not necessarily following Alzheimer patients, but studying the constellation of disorders that make up its syndrome — Parkinson’s, stroke related dementia, and other organic causes) as one of a terminal nature. They are sounding a clarion call for re-education of the public on what they call a termainal condition which requires effective palliation, at the very least.

At the moment, treatment (which may include some reversal of the pathology) of Alzheimer dementia is being heavily researched. Until the time comes for a certain cure for all causes of dementia, the importance of accurately diagnosing and crafting essential care plans for those who suffer from its horrible effects is the most effective treatment there is. Hopefully, by mid century, the estimated 17 million who will fall prey to dementia will have not only the treatments but also the resources to prevent its early mortality so prevalent in this population today. | LINK

It’s the sleeping giant. The expected increase in global Alzheimer dementia cases will do what everyone expects and acknowledges, but really refuses to do anything about. According to a report released within the past 24 hours from the Alzheimer’s Association, estimates are that 35 million people worldwide are living with Alzheimer’s and other forms of dementia. The figure is a 10% increase over 2005 numbers.

It’s no secret that research in the field for novel forms of treatment are going at a breakneck pace, with new agents expected to hit the market by 2011; the real hope is that these treatments will be widely available within the first year of availability. But the real fear is that the potential for the promise of these disease altering drugs will only be realized for a privileged few — those who can afford them. | LINK

• We’ve always known the prevalence of dementia increases with age. Here’s fresh evidence of its increasing incidence in the “oldest” old.
• Belly up to the bar? Moderate drinking may lower Alzheimer risk.
• New tests assessing brain volume may allow earlier Alzheimer detection.

In one study, Irish researchers found scans measuring brain volume and a combination of memory tests accurately identified nearly 95 percent of people who had progressed from mild cognitive impairment to early Alzheimer’s disease. In another study, U.S. researchers found that a type of brain scan that measures glucose combined with low scores on memory tests was a strong predictor of disease progression.

• Born and bred here in Minnesota: the birth of a new anti-Alzheimer drug.
• Omega-3 fatty acid supplements — a no-go in Alzheimer disease prevention.

Should patients with cognitive impairment be given caffeine supplements to stave off the typical short term cognitive deficits seen symptomatically with the disease? Well, while the jury is still out on that count, there’s no denying that for us coffee achievers on a Monday morning after a long holiday weekend, the news of this study is somewhat compelling.

Drinking five cups of coffee a day could reverse memory problems seen in Alzheimer’s disease, US scientists say. The Florida research, carried out on mice, also suggested caffeine hampered the production of the protein plaques which are the hallmark of the disease.

LINK