Active Men Lessen Later Fracture Risk - CME Teaching Brief® - MedPage Today

UPPSALA, Sweden, June 19 -- Osteoporotic fracture may be less common among men than women, but a lifetime of physical activity appears to be just as important in reducing this risk, researchers found. Action Points

Explain to interested patients that this study suggests that men appear to gain protection against hip and other fractures by physical activity.

Inform patients that increasing physical activity, even in later life, appears to further reduce fracture risk.

Fragility hip fractures were more than twice as common among men who reported little recreational exercise during 35 years of follow-up as among those who participated in sports at least three hours a week, found Karl Michaëlsson, M.D., Ph.D., of University Hospital here, and colleagues in a longitudinal study.

One-third of all hip fractures among men could be prevented by regular participation in sports, they wrote online in the journal PLoS Medicine.

This finding "is fully concordant with a similar analysis in women," noted Harri Sievänen, Ph.D., and Pekka Kannus, M.D., Ph.D., both of the UKK Institute in Tampere, Finland, in an accompanying editorial.

For postmenopausal women, moderate exercise has been shown to substantially lower hip fracture risk. For men, though, prospective observational studies have had inconsistent results.

"Given these inconsistent findings, the results … represent an important advance," Drs. Sievänen and Kannus wrote.

Dr. Michaëlsson and colleagues analyzed the physical activity component of the Uppsala Longitudinal Study of Adult Men, which surveyed 2,205 men in the city who were ages 49 to 51 when the study began in the early 1970s.

At baseline and at age 60, 70, 77, and 82 the participants completed questionnaires asking about how they spent their leisure time.

Half reported that they engaged in active sports or heavy gardening for at least three hours a week, or regularly engaged in hard physical training or competitive sports, collectively defined as high physical activity.

Another 36.4% were included in the intermediate activity category for responding that they "often" went walking or cycling for pleasure.

Only 14.7% reported spending their leisure time in mostly sedentary activities.

The men were followed for fracture using Sweden's national Hospital Discharge Register and local hospital registers and records.

During the 35-year follow-up, 482 men (22%) experienced a fracture of some type and 134 (6%) had a hip fracture. [CLICK HERE TO READ ENTIRE ARTICLE]

AAICPD: Low-Tech Tool Predicts Six-Year Risk of Dementia - CME Teaching Brief® - MedPage Today

WASHINGTON, June 11 -- The risk of developing dementia within six years can be predicted by a simple assessment tool that relies on clinical impression and patient history, researchers reported here. Action Points

Explain to interested patients that this report describes an assessment tool that has not been tested in a large randomized trial.

This report is based upon material published as an abstract and presented at a meeting. It has not been published in a peer-reviewed journal.
The key indicators were older age, non-white race, poor cognitive function, poor physical performance, extreme inactivity, history of bypass surgery, low body mass index, and lack of alcohol consumption (ROC, 0.79; 95% CI: 0.76 - 0.81; accuracy, 87%), said Deborah F. Barnes, Ph.D., of the University of California San Francisco.

The score based on these factors ranged from 0 to 14 points, and the risk of developing dementia was 6% in those with low scores (0-3 points), compared with 25% in those with moderate scores (4-6 points), and 54% in patients with high scores (≥7), she reported at the Alzheimer's Association International Conference on Prevention of Dementia.

Moreover, evaluation of these factors can be performed in a physician's office or at bedside in a hospital by a nurse practitioner or a physician's assistant, Dr. Barnes found.

She noted that this low-tech model was not as accurate as one that incorporates MRI and other expensive tests. By statistical analysis the high-tech model was significantly better (P<0.001), but the "absolute differences between the two was small."

"We wanted a tool that could be used quickly in a clinical setting and wouldn't require expensive or sophisticated measures, like MRI," she said in an interview. "We looked at a number of potential predictors and settled on these as a reasonable model that a clinician could use when evaluating an older adult."

On the basis of an analysis of data from 3,375 non-demented participants in the Cardiovascular Health Cognition Study, Dr. Barnes and colleagues developed the two models -- a bedside predictive protocol and the so-called best predictive model. At baseline, participants had a mean age of 76; 59% were women, and 15% were African American.

Fourteen percent (480) of those in the analysis developed dementia over six years of follow-up.

The best model included testing for apolipoprotein-E genotype, MRI findings, electrocardiogram findings, carotid artery ultrasound, and ankle-arm brachial index, as well as demographics, medical history, psychosocial measures, physical function, cognitive function, self-rated health and medication use.

Dr. Barnes said the simple protocol can be used to aid in evaluation of "elderly patients about whom the clinician may have some concerns or patients whose family members raise concerns about performance or ability to live independently."

Unlike cardiovascular disease or diabetes in which elevated risk triggers preventive measures, including pharmacologic interventions, Dr. Barnes conceded that little is known about preventing dementia, which also raises questions about the value of a predictive model.

She agreed that there are no medications that have been shown to reduce the risk of dementia, but said there are a number of compounds under development "so it may be that we will soon have drugs that can be used in patients who have an identified increased risk."

Additionally, she said that several studies have suggested lifestyle interventions, specifically both mental and physical exercise, that have been associated with a reduced risk of dementia.

"It would be reasonable to initiate both an exercise program and a program of mental drills or exercises such as word puzzles in patients who are identified as high risk for dementia," she said.

Elderly Pa. Women Pose For Risque Photos

(AP) GREENSBORO, Pa. Giving sultry looks and sexy smiles to the camera, 12 Pittsburgh-area women recently posed at Monongahela historical sites, baring it all -- or almost all -- to create a charity-driven calendar. The catch?

The nearly nude ladies are all in their 70s and 80s, driven to adventure by a desire to raise money for a historical society in Monongahela, a small community 17 miles southeast of Pittsburgh.

Overcoming fears the priest would walk by during a photo shoot or embarrassing their children and grandchildren, the women -- all well-known members of the tight-knit community -- are now eagerly awaiting the calendar's debut next month. The money it generates will go to the Monongahela Area Historical Society.

"One of the advantages of being old is that you can do anything you want and get away with it," said 80-year-old Lois Phillips, who as Miss September was photographed in the back seat of a 1968 Mercury convertible.

The calendar was the brainchild of 80-year-old Lorys Crisafulli. She came up with the idea when she saw the movie Calendar Girls, a 2003 flick starring Helen Mirren in which a group of British women publish a nude calendar to raise money for cancer research.

"I thought, why don't we do that in Monongahela?" she told the Pittsburgh Post-Gazette. "We need something to put us on the map, to get us going."

Crisafulli spent the next few weeks finding sponsors, a free photographer and an eager group of septuagenarians and octogenarians with enough spunk to show some flesh.

A former 5th grade teacher, Crisafulli is about to become better known as Miss January, who lounges in a black convertible covered in pearls, holding a champagne glass in one hand and dangling slinky sandals from the other.

Some of the other photos are more risque.

Miss April, Esther Cox, poses in a pasture, nothing but a pink umbrella covering her 75-year-old body. Miss December, Sondra Odelli Bordini, gives a sultry glance from behind a poinsettia centerpiece with two strategically placed red Christmas balls.

New Drugs Cool Rheumatoid Arthritis Flames - CME Teaching Brief® - MedPage Today

VIENNA, June 13 -- Three drugs, two approved and one in the pipeline, are improving care for patients with severe rheumatoid arthritis (RA) according to clinicians here. Action Points

Explain that patients with severe rheumatoid arthritis have varying responses to anti-inflammatory drugs and disease-modifying antirheumatic drugs, and that they may respond to drugs differently than other patients with RA.
The three agents -- rituximab (Rituxan), abatacept (Orencia), and toclizumab (Acterma) -- all reduce signs and symptoms of RA, improve physical function and health status, and slow joint damage progression, said Josef S. Smolen, M.D., of the Medical University of Vienna, and colleagues.

The heterogeneity of the disease is one of the reasons why no single therapy is effective for all patients or for one patient at all times, the authors wrote in a review article published in the online edition of The Lancet.

Disease-modifying anti-rheumatic drugs such as the anti-tumor necrosis factor (TNF) agents etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira), in combination with methotrexate, have significant anti-inflammatory and joint-protecting activity, they noted.

Yet, they noted, the combination of a TNF antagonist and methotrexate is better at protecting against radiographically confirmed progression of joint damage in patients with low disease activity than in patients with highly active disease.

To see if there might be relief for those patients, the investigators reviewed the action, efficacy, and safety of the three newer agents, each of which has a mechanism of action different from that of established anti-arthritis agents.

Rituximab, an anti-CD20 antibody with proven efficacy in the treatment of both rheumatoid arthritis and B-cell non-Hodgkin's lymphoma, is approved in the U.S. and Europe for treatment of rheumatoid arthritis in patients who have failed TNF-inhibitor therapy.

"The rationale for use of rituximab in treatment of this disease comes from the fact that B cells have several functions in disease pathogenesis, including antigen presentation and (auto)antibody and cytokine production," the investigators wrote. "Although rituximab leads to considerable reduction of concentrations of rheumatoid factor, the mechanism of action in rheumatoid arthritis is not clear."

In clinical trials, rituximab was associated with reduction in rheumatoid arthritis symptoms by more than 50% for more than a third of patients. Although the drug rapidly depleted B cells in all clinical trials, with an effect lasting for more than six months in most cases, the disease flares up again as B cells repopulate, and retreatment is necessary to maintain efficacy, the authors noted. CLICK HERE TO READ ENTIRE ARTICLE

Better Education Spurs Alzheimer's Patients to Try Risky Treatments

SUNDAY, June 10 (HealthDay News) -- Alzheimer's disease patients who have a better understanding of their condition seem to be more willing to accept potentially risky treatments, a U.S. study finds.

Researchers at the University of Pennsylvania interviewed 34 people with mild to moderate Alzheimer's who lived in the community. The patients were asked if they would want to take medications that would delay the progression of Alzheimer's for one year. The patients were told the risk of the treatments ranged from a 30 percent chance of pain to a 10 percent chance of death.

Patients with more insight into their symptoms, diagnosis and prognosis were generally more risk-tolerant, the study found. Patients who were willing to accept increased risk also were more likely to be judged competent to make a treatment decision and more capable of analyzing the risks, benefits and purpose of a medication.

"From the patient perspective, the willingness to take a risky Alzheimer's treatment is more driven by their awareness of their illness and their capacity to understand, appreciate and reason through a treatment's purpose, benefits and risks to themselves, and not so much on the severity of their Alzheimer's disease," study author Jason Karlawish, an associate professor of medicine and associate director of the university's Memory Center, said in a prepared statement.

The study was to be presented at the Alzheimer's Association International Conference on Prevention of Dementia, in Washington, D.C.

This type of research may help drug companies, doctors and regulatory agencies better understand Alzheimer's patients' willingness to accept risky treatments, he said.

Karlawish noted that several treatments currently being tested may "present more than minimal risks to patients. For example, researchers had to stop one of the early studies of the anti-amyloid vaccination because subjects developed encephalitis, a dangerous inflammation of the brain."

In a second study presented at the conference, researchers conducted an Internet survey of 2,146 Americans, aged 60 and older. They found they were willing to accept a 46.8 percent increase in the risk of death or disability for treatments that would prevent mild Alzheimer's from progressing to more serious stages.

"This survey is the first to our knowledge that is able to quantify this fear of Alzheimer's in a manner that could be useful to health authorities as they plan for the increase in Alzheimer's brought on by the aging of our population," study author Reed Johnson, senior fellow and principal economist at RTI Health Solutions, said in a prepared statement.


More information
The Alzheimer's Association outlines treatment options for Alzheimer's disease.

At the 2007 Alzheimer's Association International Conference on the Prevention of Dementia - Neurochem's U.S. Principal Investigator Presents Update on Tramiprosate
(ALZHEMED(TM))
Monday June 11, 5:55 am ET


WASHINGTON, DC, June 11 /CNW Telbec/ - Paul S. Aisen, M.D., Professor of Neurology and Medicine at Georgetown University Medical Center, and principal investigator in the United States of Neurochem Inc.'s North American Phase III clinical trial for tramiprosate (ALZHEMED(TM)) will present today an update on Neurochem's investigational product candidate for the treatment of Alzheimer's disease (AD). The presentation by Dr. Aisen will take place at the Intervention and Treatment Session, scheduled from 2:30 - 4:30 P.M. (ET), at the Alzheimer's Association International Conference on Prevention of Dementia in Washington, DC. In his presentation entitled, A Phase III Study of the Efficacy, Safety and Disease Modification Effect of Tramiprosate in Mild-to-Moderate Alzheimer's Disease, Dr. Aisen will review the Phase III clinical trial and provide an update.

Neurochem announced in April 2007 that an adjustment to the initial statistical model, as set out in the statistical plan, would be necessary to provide accurate results. The procedure to arrive at a reliable model involves a detailed analysis of potential confounding factors, and Dr. Aisen will present on the progress to date. In addition, Dr. Aisen will provide an update on the progress in the analysis of the Phase III clinical trial primary endpoint data. Some preliminary descriptive data shows numerical differences in favor of tramiprosate (ALZHEMED(TM)) on the primary clinical endpoint and also shows differences between groups on the primary disease modification endpoint as measured by magnetic resonance imaging (MRI). However, work regarding the adjustment of the statistical model is ongoing and, therefore results of the Phase III clinical trial cannot be derived from the preliminary data nor can statistical significance be assigned at this time. Accordingly, no predictions or conclusions can yet be made regarding the outcome of the Phase III study.

Neurochem continues to expect to announce the top-line results of the trial during the second quarter of this year, although they may not be available within this timeframe. The actual timing of the release of these top-line results depends on completing the adjustments to the initial statistical model.

Alzheimer's Association News Briefing

The Alzheimer's Association has invited Dr. Aisen to present on the tramiprosate (ALZHEMED(TM)) program for inclusion in a news briefing to be held today, June 11, 2007, at 12:00 P.M. (ET).

Continuing Medical Education Symposium

Neurochem is also supporting a CME symposium on June 11 at 6:30 PM at the conference. The symposium, entitled Confronting the Burgeoning AD Crisis: New Frontiers, is sponsored by Professional Postgraduate Services(R). The invited faculty presenters are Howard M. Fillit, MD, Steven T. DeKosky, MD and Serge Gauthier, MD, and they will examine the burden of AD and assess the need for improving diagnosis, with a special focus on shifting the treatment paradigm from managing symptoms to treating the underlying causes of the disease.

Neurochem Poster Presentations

Neurochem is also exhibiting three poster presentations on tramiprosate (ALZHEMED(TM)) at this conference. All posters are displayed in the Exhibit Hall of the Marriott Wardman Park Hotel, open on June 10 from 10:30 A.M. to 6:30 P.M. (ET) and on June 11 from 9:30 A.M. to 4:30 P.M. (ET).


- Presentation P-187, entitled Tramiprosate Is Neuroprotective and
Reduces the Levels of Secreted Amyloid-ss in Organotypic Hippocampal
Slice Cultures, will be presented by lead author Mounia Azzi.
- André Galarneau will present GABA-Dependent Pathways in the
Neuroprotective Effect of Tramiprosate against Amyloid-ss Toxicity
in presentation P-190.
- Barry D. Greenberg will present Tramiprosate Decreases Amyloid-ss
Induced Erk1/2 Activity in Primary Rat Neurons by a GABA-Independent
Pathway in presentation P-192.

About Neurochem

Neurochem Inc. is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(KIACTA(TM)) is currently being developed for the treatment of Amyloid A (AA)
amyloidosis, and is under regulatory review for marketing approval by the
United States Food and Drug Administration, European Medicines Agency and
Swissmedic. Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer's
disease, has completed a Phase III clinical trial in North America and is
currently in a Phase III clinical trial in Europe, while tramiprosate
(CEREBRIL(TM)), for the prevention of Hemorrhagic Stroke caused by Cerebral
Amyloid Angiopathy, has completed a Phase IIa clinical trial.

To Contact Neurochem

For additional information on Neurochem and its drug development programs,
please call the North American toll-free number 1 877 680-4500 or visit our
Web Site at: www.neurochem.com.

This news release contains forward-looking statements regarding
tramiprosate (ALZHEMED(TM)) as well as regarding continuing and further
development efforts. These statements are based on the current analysis and
expectations of management. Drug development necessarily involves numerous
risks and uncertainties, which could cause actual results to differ materially
from this current analysis and these expectations. Analysis regarding the
results of clinical trials may not provide definitive results regarding
safety, tolerability or therapeutic benefits. Even if all the endpoints sought
in the clinical trials were met (which is not certain), there is no certainty
that regulators would ultimately approve tramiprosate (ALZHEMED(TM)) for sale
to the public. Risks and uncertainties may include: failure to demonstrate the
safety, tolerability and efficacy of our product, that actual results may vary
once the final and quality-controlled verification of data and analyses has
been completed, the expense and uncertainty of obtaining regulatory approval,
including from the FDA, and the possibility of having to conduct additional
clinical trials. Further, even if regulatory approval is obtained, therapeutic
products are generally subject to: stringent on-going governmental regulation,
challenges in gaining market acceptance, and competition. Neurochem does not
undertake any obligation to publicly update its forward-looking statements,
whether as a result of new information, future events, or otherwise. Please
see the Annual Information Form for further risk factors that might affect the
Company and its business.

For further information

Lise Hébert, PhD, Vice President, Corporate Communications, (450) 680-4572, lhebert@neurochem.com

Medivation Alzheimer's Data Show Benefit
Monday June 11, 7:53 am ET
Medivation Study Shows Dimebon Benefit in Treatment of Alzheimer's Disease


NEW YORK (AP) -- Biotech drug developer Medivation Inc. said Monday its Alzheimer's treatment Dimebon significantly improved symptoms of the disease over one year.
The mid-stage clinical trial found that patients with mild-to-moderate Alzheimer's disease given Dimebon showed benefits in cognition, overall clinical function, activities of daily living, and behavioral problems compared with those patients given a placebo.

The company also noted that benefits from Dimebon at one year were stable or greater compared to benefits at six months.

The Alzheimer's Association estimates that about 26.6 million people had the disease in 2006, with researchers predicting that the number will jump to more than 100 million by 2050 worldwide.

Neuro-Hitech, Inc. (NHPI) Completes Patient Enrollment for U.S. Phase II Clinical Trial of Huperzine A
Jun 11 2007, 8:31 AM EST
Business Wire


Neuro-Hitech, Inc. (NASDAQ: NHPI) today announced that its U.S. Phase II clinical trial of Huperzine A is fully enrolled. In December 2006, a decision was made to increase enrollment from the original target of 150 by an additional 60 patients. Enrollment was recently concluded with 210 subjects at 35 trial sites throughout the U.S.

This Phase II clinical trial of Huperzine A is a randomized, placebo-controlled study designed to evaluate the compound's safety and efficacy in improving cognitive function of Alzheimer's patients. The study design used a three parallel-arm approach, meaning that patients are randomly assigned into one of three equally sized groups. Each group is administered either Huperzine A twice daily in an escalating 200mcg dose, Huperzine A twice daily in an escalating 400 mcg dose, or a placebo. The study is 24 weeks in length with the primary end-point being the ADAScog score at 16 weeks. After 24 weeks, patients are offered the option to participate in an open label extension for up to a total of 32 weeks while placebo patients are offered active drug at 16 weeks.

The Phase II trial of Huperzine A has been supported by some of the notable researchers and organizations in the Alzheimer's disease community. Dr. Paul Aisen, Professor of Neurology and Medicine at Georgetown University and one of the first clinicians to conduct formal trials in Alzheimer's disease, is the lead investigator for this trial. The National Institutes of Health (NIH) and the Alzheimer's Disease Cooperative Study (ADCS) have also been influential in the conduct of this important clinical trial.

Mr. Reuben Seltzer, Chief Executive Officer of Neuro-Hitech commented, "The entire management team is pleased that enrollment has closed in the Phase II trial of Huperzine A. Because of support from Dr. Paul Aisen, the National Institute of Health, the Alzheimer's Disease Cooperative Study and many others, this trial has been executed flawlessly."

About Neuro-Hitech, Inc.

Neuro-Hitech, Inc. is a New York-based biopharmaceutical company focused specifically on the development and commercialization of next-generation therapies against proven targets for neurodegenerative diseases. Our lead product candidate, Huperzine A, is being clinically tested for efficacy and safety in the treatment of Alzheimer's disease. Huperzine A has been shown to protect nerve cell death and have a longer duration of acetylcholinesterase inhibitory action relative to other cholinesterase inhibitors. In addition to Huperzine A, Neuro-Hitech has two major preclinical development programs. One consists of a portfolio of second-generation anti-amyloid compounds that target A-beta and Tau proteins. The other targets the development of a novel series of compounds designed to treat (anti-ictogenic) and prevent (anti-epileptogenic) epilepsy.

Find more information about Neuro-Hitech online at www.neurohitech.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act and Section 21E of the Exchange Act). To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "projects" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include those outlined in "Risk Factors" found within our Annual Report on Form 10-KSB and include, without limitation, Neuro-Hitech's limited cash and ability to raise capital to finance the growth of Neuro-Hitech's operations, the ability of Neuro-Hitech to develop its products and obtain necessary governmental approvals, Neuro-Hitech's ability to protect its proprietary information, Neuro-Hitech's ability to attract or retain qualified personnel, including scientific and technical personnel and other risks detailed from time to time in Neuro-Hitech's filings with the SEC, or otherwise.

Unexplained Late-life Weight Loss May Be Early Predictor Of Alzheimer's Disease
Science Daily — New findings show unexplained weight loss that precedes dementia by more than 10 years is associated with the severity of Alzheimer changes in the brain.

Using data from the Nun Study, a prospective study of the causes of dementia in Catholic sisters, University of South Florida researcher James Mortimer, PhD, reported today that the most likely cause of the unexplained weight loss is the severity of the Alzheimer changes in the brain rather than an eating disorder or other condition associated with declining cognition. Dr. Mortimer presented the findings at the Alzheimer's Association International Conference on the Prevention of Dementia in Washington, DC.

Although a previous study showed that individuals with lower weight for their height at the time of death had more Alzheimer brain changes at autopsy, this is the first study to show that lower weight up to 10 years earlier is specifically related to the severity of the disease.

"While weight one year or less prior to death was related to the amount of cognitive decline, this association could be explained by the severity of the Alzheimer process in the brain seen at autopsy," said Dr. Mortimer, professor of epidemiology at the USF College of Public Health.

"Given its very long duration prior to onset of dementia, it is likely that weight loss is specifically associated with the Alzheimer disease process and not to a restriction in food intake due to cognitive decline," he said. "There is considerable evidence that Alzheimer changes in the brain precede the first symptoms of this illness by decades."

Unexplained weight loss late in life, when coupled with other biomarkers, may help to identify those at risk of Alzheimer's disease more than a decade in the future. Identification of individuals who are at high risk of Alzheimer's long before cognitive decline becomes evident will be critical to its prevention once agents become available to slow the disease, Dr. Mortimer said.

The Nun Study, begun in 1992, is a study of 678 Catholic sisters, initially 75 to 102 years of age, who are evaluated yearly and who agreed to brain donation at the time of death. The Nun Study is directed by Dr. David Snowdon of the University of Kentucky. Dr. Snowdon is a co-author of the presentation as is Dr. William Markesbery, director of the Sanders-Brown Center on Aging at the University of Kentucky. Dr. Yougui Wu, the third coauthor, is an assistant professor of epidemiology and biostatistics at the USF College of Public Health

The Nun Study is funded by a grant from the National Institute on Aging.

Note: This story has been adapted from a news release issued by University of South Florida Health.

CLICK HERE TO READ ENTIRE ARTICLE

IN the book “Mrs. Frisby and the Rats of NIMH,” a group of lab rats acquire human intelligence through a genetic experiment. Every child recognizes the charming tale as pure fantasy, yet something similar is occurring at a major pharmaceuticals company, Wyeth, where rodents tested in its labs have, indeed, taken on some features of the human brain.

Unlike the fictional rats that learned to read, write and operate machinery, Wyeth’s animals are slow-witted, confused and forgetful because they suffer from the crippling dementia of Alzheimer’s disease, which they acquired from a transplanted human gene.

Something else extraordinary is going on at Wyeth. The company’s scientists not only can give rodents Alzheimer’s — they have also figured out how to take it away. Curing mice is a lot simpler than curing people, but the results are a tantalizing development that offers hope to humans suffering from the disease. The work also advances what Wyeth executives describe as their war on Alzheimer’s.

Wyeth’s team faces a formidable foe. In an industry often criticized as making pricey “me too” drugs that involve minor tweaks to competitors’ products, as well as promoting medicines of marginal value, Wyeth has decided to go full bore against Alzheimer’s, a disease that has defied effective treatment since it was first identified a century ago. The company has dedicated more than 350 scientists exclusively to Alzheimer’s research, and they are working on 23 separate projects for medicines to possibly treat the disease.

About five million people in the United States are living with Alzheimer’s, according to the Alzheimer’s Association, an advocacy group funded by individual donors as well as foundations and major corporations, including drug makers. Without a cure or new treatments, the number of those with the disease could grow to 13.2 million by 2050, the National Institute on Aging estimates.

“I think this is going to be the disease, and maybe one of the biggest health care political issues of my generation,” says Robert Essner, 59, Wyeth’s professorial chief executive. “It’s hard for anyone to envision how to provide health care in the United States if you’re going to have to deal with the burden. You just start to add up the cost, 20 years from now as my generation gets old — it’s phenomenal.”

Mr. Essner will have more than a host of grateful baby boomers awaiting him if Wyeth’s crusade is successful. The company could snare a big financial payoff from what still amounts to a risky bet, one that has already cost Wyeth about $450 million in research funds. But with a treatment that slows progress of the disease possibly selling at more than $20,000 a year, the company’s Alzheimer’s program is one reason that some analysts are voicing renewed enthusiasm about Wyeth’s stock, which had been weighed down for years by costly fen-phen diet drug litigation.

Wyeth is hardly the only company looking for Alzheimer’s treatments. Virtually every large drug maker and a number of smaller biotechnology companies are working to develop Alzheimer’s drugs, with several hundred ideas under study. Several companies are expected to announce results of clinical studies during an international Alzheimer’s meeting that is under way in Washington. “There seems to be a current of excitement,” said Peter Davies, a biochemist at the Albert Einstein College of Medicine in the Bronx, who has studied Alzheimer’s for 30 years. Dr. Davies is working with Eli Lilly and Applied NeuroSolutions on a possible course of treatment that is such a secret that he will not say anything about it. “I wouldn’t say it’s a race,” Dr. Davies said, “but this is novel and we want to get a jump on therapeutics.”

The four Alzheimer’s treatments now on the market work by regulating the action of chemical neurotransmitters in the brain. The drugs — Aricept by Eisai and Pfizer, Exelon by Novartis, Razadyne by Johnson & Johnson and Namenda by Forest Laboratories — have shown mixed results treating Alzheimer’s symptoms and do nothing to stop the disease’s progress.
Dr. Todd Golde, professor of neuroscience at the Mayo Clinic, says that the drugs are not very effective, and that consumers’ large expenditures for them — about $1.4 billion in the United States alone last year, according to data from Verispan — reflect the desperation of patients and their families to treat the disease.

“It’s scary if you look at the trials that got these drugs approved,” Dr. Golde said. “The change in mental status was so small, the average caregiver of a patient would have no way of knowing there was any difference.” While there is no evidence that any of the drugs stem the underlying disease, they were approved based on studies showing temporary improvement or stabilization in some patients with Alzheimer’s. The changes can be as minor as a better ability to dress oneself or to take out the trash.

In one study of people taking Namenda and Aricept combined for six months, 60 percent of patients either improved or did not deteriorate. “I would say that physicians do believe these drugs are of benefit to patients with Alzheimer’s,” said Stephen M. Graham, senior director of clinical development at Forest.

Spokesmen for the other companies with Alzheimer’s drugs echoed that assessment in regard to their products, pointing to clinical studies demonstrating that they help patients.
Wyeth is wagering that it can find more promising treatments for a nebulous, stealthy disease that does more than rob people of their health and well-being. It also steals some of their most precious memories.

AT first blush, Robert Essner seems an unlikely flag bearer for a corporate assault on Alzheimer’s. The son of a college professor, Mr. Essner studied humanities as an undergraduate and in graduate school, intending to teach college history. But after he graduated from the University of Chicago in 1971 with a master’s degree in history, he soon realized that jobs in his field were scarce. He says he stumbled into pharmaceuticals by answering an ad in The Wall Street Journal.

Today, he is on the leading edge of a generation that is facing a huge emotional and financial burden from a disease that leaves victims requiring full-time nursing care. He is urging a national mobilization against what he describes as a looming Alzheimer’s “epidemic.”
Mr. Essner often speaks publicly about the disease, stepping outside his role as corporate chief and into the public policy arena. Last month, he testified at a Senate hearing, recommending that the National Institutes of Health double its current annual funding of $643 million for Alzheimer’s research.

Seated recently at a conference table at the company’s headquarters on pastoral property near Madison, N.J., Mr. Essner said he has taken to the podium because he thinks Alzheimer’s should garner the same attention that AIDS received during the 1980s and 1990s, when a coalition of government and industry worked feverishly to find treatments.

He says he is concerned as much about the disease’s dehumanizing effects as he is about its costs. “You see mothers who don’t recognize their daughters,” he says.CLICK HERE FOR MORE

Home Visits by Researchers Would Boost Alzheimer's Trials
MONDAY, June 11 (HealthDay News) -- Home visits by researchers may help increase the number of caregivers who are willing to enroll Alzheimer's disease patients in clinical trials, a new study finds.

It could also boost the number of patients who stay enrolled in trials, the University of Pennsylvania researchers added.

The team interviewed 108 caregivers of Alzheimer's patients who lived in the community. Caregivers were asked about their willingness to enroll their loved ones in hypothetical studies which differed according to four variables: location of study; method of transportation to study visits; chance of receiving a drug or placebo; and level of risk of the study drug.

Of the 108 caregivers, 17 percent were willing to take part in a high-risk clinical trial with no amenities. That increased to 27 percent when home visits were added and to 60 percent when low risk, home visits, and a higher chance of the patient receiving an active treatment were included, the study found.

The option of having home visits (which eliminates the inconvenience of traveling to a clinic) offset the negative study features, such as taking a high-risk drug. It also made caregivers of sicker patients more willing to sign up for studies, the researchers said.

"Altering studies to include home visits could result in shorter recruitment periods and increased patient retention rates," study author Jason Karlawish, associate professor of medicine and associate director of the PENN Memory Center, said in a prepared statement.

"The amount of time we save through these alterations could offset the added costs of the home visits, and, in fact, we may save considerable time and expense if the participants don't have to come in to the clinic so often," he said.

The study was to be presented at the Alzheimer's Association International Conference on Prevention of Dementia, in Washington, D.C.

"Other than lack of sufficient funding, recruiting and retaining clinical volunteers is now the single greatest impediment to developing better treatment and prevention strategies for Alzheimer's," William Thies, vice president for medical and scientific relations at the Alzheimer's Association, noted in a prepared statement.

More information
The Fisher Center for Alzheimer's Research Foundation has more about taking part in a clinical trial.

Early Alzheimer's Detection by Gene 'Signature' In Blood Possible

Early Alzheimer's Detection

With anticipation running high of breakthroughs in Alzheimer's disease therapies, reports of the latest results from studies on early detection of Alzheimer's took on added urgency.

The studies included examination of blood samples examined for a "signature" set of genes, an innovative analysis of both MRI and PET scan images, novel combinations of memory and cognitive tests, and a predictive model based on an easy-to-assess mixture of test results and health/lifestyle history.

"Potential disease modifying drugs for Alzheimer's are very likely on the horizon, so we need accurate and easy-to-use early identification techniques for Alzheimer's so that we can initiate treatment earlier," said William Thies, PhD, vice president of Medical and Scientific Relations at the Alzheimer's Association. "And until disease modifying drugs are available, early detection empowers people to plan for their future sooner, including financial and legal matters, along with getting access to resources such as support groups, disease information and research studies."

Improvements in early detection of Alzheimer's in recent years have granted researchers and service providers, such as the Alzheimer's Association, access to a population of people who are able to articulate their experiences and needs.

"By better understanding the experiences of people living with Alzheimer's, we can significantly improve clinical studies, medical practice, caregiving and services," Thies said.

Still, a large proportion of people with Alzheimer's are not diagnosed until the disease is in the moderate or advanced stages, according to the Alzheimer's Association.

"The National Institute on Aging, the Alzheimer's Association and industry are pushing hard for earlier detection and earlier intervention through efforts such as the Alzheimer's Disease Neuroimaging Initiative (ADNI)," said session moderator and neuroimaging expert Michael Weiner, MD, of the San Francisco Veterans Affairs Medical Center and the University of California, San Francisco, who is ADNI's principal investigator. "Ultimately, we hope that brain and biological changes in Alzheimer's can be detected before memory decline and other symptoms appear."

Gene "Signature" In Blood May Detect Alzheimer's

At the Alzheimer's Association Prevention Conference, scientists working for Norwegian biotech company, DiaGenic ASA, presented results of a study using an assay that detects a unique gene expression profile or "signature" in blood samples.

Researchers combed through many Alzheimer patient samples and several thousand genes to identify what they believe to be a common gene signature for Alzheimer's that they could test. The most informative genes isolated in these discovery phase studies were then used to design and develop customized test arrays. The scientists presented results from a cohort of 119 subjects (53 with Alzheimer's, 58 age matched controls, and 8 younger controls), using two different detection technology platforms. The researchers generated one gene "signature" using about 1,200 genes giving a specificity of 84 percent, a sensitivity of 86 percent and thus an accuracy of 85 percent. A second "signature" within a 96-gene setting gave a specificity of 73 percent, a sensitivity of 84 percent and an accuracy of 79.5 percent.

"As with all new diagnostic tests, ours will also require validation with a large number of Alzheimer's patients and control subjects at multiple centers. This is already in progress, and next year we'll know how well the test will perform," said Anders Lonneborg, PhD, Research Director at DiaGenic ASA. [CLICK HERE FOR MORE...]

Nolan just wants dad to remember: Father of 49ers coach losing ground in battle with Alzheimer's disease
By Dennis Georgatos, MEDIANEWS STAFF

49ers head coach Mike Nolan is coping with a father who has Alzheimer's disease.

Nolan plans to phone his dad next Sunday and wish him the best on Father's Day, like he always does. But there's a difference this year.

"I don't know if he'll recognize me, but I'll call him still," the 49ers coach said.

Dick Nolan, the first half of the only father-son tandem to coach the same NFL team, is losing ground in his battle with Alzheimer's disease, with his recent failures to recognize even his closest family members the most telling and heartbreaking indicator.

The elder Nolan has struggled for several years with Alzheimer's. The disease attacks nerve cells in the brain, destroying memory and the ability to think clearly and perform daily tasks, from brushing teeth to remembering which key unlocks the front door.

Over the past year, Mike Nolan said, his father's condition has degenerated, compounded by a worsening case of prostate cancer.

"Last summer, the 49ers alumni here held a reunion for him, and that was great," Nolan said. "He was still able to communicate with all the guys and know who was who. But right now, he wouldn't know those same guys."It's been difficult. It has been most difficult for mom and for my three siblings who live in Dallas, because they're around Dad every day."

Nolan and his wife, Kathy, have traveled to Dallas twice in the past four months. On the most recent trip three weeks ago, Nolan, along with his six siblings, were with their mother, Ann, to help arrange their father's placement in a care facility for dementia and Alzheimer's patients.

The family's decision arose from the increasing difficulties Ann Nolan encountered in trying to take care of her 75-year-old husband at home.

"One of the things I thought was sad that happened was he didn't recognize my mother as his wife," Nolan said. "So when she tried to help him with anything from just showering or using the bathroom — he's a very modest man — he wouldn't let her even be in there, and he really wasn't able to get it done right. It became very difficult for her to help him."

Nolan has largely avoided speaking publicly about his father's illness for the past two years. Even when he was named 49ers coach Jan. 19, 2005, 37 years to the day after his father began coaching the team, Nolan decided against having him at his introductory news conference. The elder Nolan had begun showing signs of Alzheimer's, and his son wanted to spare him from a potentially uncomfortable public moment.

Mike Nolan also knew the elder Nolan often forgot he had been diagnosed with Alzheimer's. If he saw or heard anything in the paper or on TV linking him to the illness, it would be like finding out for the first time that he had it, and that potentially could happen over and over again. Each time, his father agonized over the ramifications of the illness and the realization, in his flickering awareness, that he could no longer help his son do his job.

Last week, though, Mike Nolan began speaking out in hopes of raising awareness of Alzheimer's and dementia. He also wanted to help get the word out about the "88 Plan," a joint program by the league and the players union to provide up to $88,000 a year to help pay for the care of former players with dementia or Alzheimer's.

The plan takes its name from the number worn by Hall of Fame tight end John Mackey, who has dementia.

While there is no known definitive link between multiple concussions and the onset of Alzheimer's or other dementia conditions, some studies indicate it could be a factor.
Dick Nolan, an "88 Plan" participant, played nine years in the NFL as a defensive back, and Mike Nolan said his dad "had a lot of concussions, as all of them did back then.

"I don't know" whether they were a factor, Nolan said. "I don't pretend to be a doctor or scientist. But I certainly appreciate what they're doing as far as research and as far as the medical plan the NFL is doing for them. And I want them to continue to do it so we can find a cure for this. A lot of people have it."

Through it all, Nolan said, he has come to understand what people mean when they say someone with Alzheimer's disease or dementia "dies twice."

"When they don't know who you are any longer, that's tough to deal with," he said.

With his father, it's not a total blackout — yet. Nolan said when he arrived in Dallas for his visit in late March, his father initially recognized him. But soon after, his father — the rough-and-tumble cornerback, the co-inventor with Tom Landry of the "flex defense" — seemed to be in a daze.

"Those momentary recognitions, when he'll reach out, when he'll say something, those are the hardest," Nolan said, his voice quieting to a whisper. "I mean, there's that ray of light, and then it's gone."

Alzheimer's Patients Get RFID Chip

(June 11, 2007) Twenty-five Alzheimer's patients were implanted with radio frequency identification chips that can be linked to their medical records. The patients were implanted last week at the 2007 Alzheimer's Educational Conference in West Palm Beach, Fla.

The chips, from VeriChip Corp., Delray Beach, Calif., work with the vendor's VeriMed Patient Identification System. Each chip contains a 16-digit identification number that is linked to a patient's medical records in a database at the medical facility. Waving the vendor's RFID reader over a patient implanted with a chip can capture the number. Emergency personnel can also use the scanner to identify patients.

The event was sponsored by Alzheimer's Community Care, a local provider organization. Those who elected to receive the chip are not part of VeriChip's recently announced study with the organization, which will implant 200 Alzheimer's patients and their caregivers with the chips. In the study, the patient's medical record will include their Alzheimer's diagnosis, related medications, caregiver contact information, and other information.

For more information, go to verichipcorp.com.

Alzheimer's Cases May Quadruple

(WASHINGTON) — More than 26 million people worldwide have Alzheimer's disease, and a new forecast says the number will quadruple by 2050. At that rate, one in 85 people will have the brain-destroying disease in 40 years, researchers from Johns Hopkins University conclude.

The new estimates, being presented Sunday at an Alzheimer's Association conference in Washington, are not very different from previous projections of the looming global dementia epidemic with the graying of the world's population.

But they serve as a sobering reminder of the toll to come if scientists cannot find better ways to battle Alzheimer's and protect aging brains.

"If we can make even modest advances in preventing Alzheimer's disease, or delay its progression, we could have a huge global public health impact," said Johns Hopkins public health specialist Ron Brookmeyer, who led the new study.

The biggest jump is projected for densely populated Asia, home of almost half of today's Alzheimer's cases, 12.6 million. By 2050, Asia will have 62.8 million of the world's 106 million Alzheimer's patients, the study projects.

A recent U.S. study estimated that this nation's Alzheimer's toll will reach 16 million by 2050, compared with more than 5 million today. The new estimate is significantly lower, suggesting only 3.1 million North American cases today and 8.8 million by 2050.

Among the estimates for other regions are:
*Africa, 1.3 million today and 6.3 million in 2050.
*Europe, 7.2 million and 16.5 million.
*Latin America and the Caribbean, 2 million and 10.8 million.
*Oceania, 200,00 and 800,000.

The project was funded by Elan Pharmaceuticals and Wyeth Pharmaceuticals.

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