MORRISTOWN, N.J.

Watson Pharmaceuticals Inc. said Thursday it began selling a generic version of Novartis AG’s Alzheimer’s disease drug Exelon.

Watson said it started shipping generic exelon, or rivastigmine, in doses of 1.5, 3, 4.5, and 6 milligrams. The drug is used to treat dementia in Alzheimer’s patients.

Watson said U.S. sales of Exelon were $425 million in the 12 months ended April 30.

Novartis, a Swiss drugmaker, agreed to let Watson launch a generic version of Exelon as part of a patent lawsuit settlement in December 2007.

In morning trading, Watson stock slid 52 cents to $40.05 and Novartis shares rose 10 cents to $48.42.

SOURCE: www.businessweek.com

Scientists have discovered changes in the brains of normal individuals at high risk for Alzheimer’s disease that could prove important for early detection of the disease.

The research team at the University of Kentucky’s College of Medicine, led by Brian Gold, associate professor of anatomy and neurobiology, focused on the brain’s white matter, which forms the majority of deep parts of the brain and consists primarily of myelinated nerve cell processes, or axons.

These myelinated axons serve to connect the brain’s gray matter regions, which contain nerve cell bodies.

“The brain’s white matter can be thought of as a set of telephone wires which enable communication between gray matter ‘thinking regions’,” Gold said.

Previous studies have demonstrated decline in both gray and white matter tissue types in individuals with Alzheimer’s. In the current study, the authors sought to determine which of these changes are present in normal seniors at high risk for Alzheimer’s disease, a likely target group for emerging interventions.

The high-risk group consisted of individuals whom have both genetic and family risk factors for Alzheimer’s disease but do not yet show cognitive changes.

The low-risk control group consisted of individuals who had neither risk factor but were similar to the high-risk group in terms of age, education level and cognitive functioning.

The study used several magnetic resonance imaging (MRI) techniques to assess the integrity of gray matter and white matter brain tissue in the high and low risk groups. In particular, a recently developed form of MRI called diffusion tensor imaging (DTI) was used to assess the integrity of the brain’s white matter.

This technique allows for assessment of the microstructural integrity of axons and their surrounding myelin.

Results indicated that the two groups did not differ in the tissue volumes of several gray matter regions know to contribute to memory function.

However, the high-risk group showed decreased integrity in white matter tracts that inter-connect gray matter regions involved in memory function. Both the axonal and myelin integrity of these white matter tracts were reduced.

These data suggest that changes in white matter connections may be among the earliest brain changes in Alzheimer’s disease, which may prove important for early detection by non-invasive imaging.

In addition, the findings may have implications for the development of new preventative treatment interventions in Alzheimer’s disease, which could attempt to protect axon and myelin integrity in seniors at risk for this neurological disorder.

The findings were published in an article in the journal Neuroimage. (ANI)

SOURCE: http://sify.com

Written by Meredith Farley

Tuesday, 29 June 2010 15:04

A group of researchers in Italy may have found encouraging results for people with Alzheimer’s disease who might be losing their language skills, HealthDay.com reports.

The study found that a new non-invasive treatment called repetitive transcranial magnetic stimulation (rTMS), which fires magnetic pulses into the brain, has been shown to change brain activity.

Lead researcher Maria Cotelli told the news source that the findings “hold considerable promise, not only for advancing our understanding of brain plasticity mechanisms, but also for designing new rehabilitation strategies in patients with neurodegenerative disease.”

According to the outlet, Cotelli and her team tried rTMS on patients with moderate Alzheimer’s and tested their memory, executive fucntion and language at the beginning, middle and end of the the study. At the end, the researchers found that the number of correct answers on a comprehension test taken by subjects increased from 66 percent to 77 percent after treatment.

While language was improved, the study offered little evidence that rTMS positively-affected memory. According to the Texas Department of State Health Services, approximately 5.3 million Americans have Alzheimer’s disease and almost half of people over the age of 85 suffer from the illness.

SOURCE: www.retirementhomes.com

It’s an appealing notion that our daily pick-me-up may also confer a range of health benefits. And for coffee drinkers there’s a lot of research percolating. Several studies suggest that a daily caffeine habit may help protect against Alzheimer’s disease. But there’s a catch. The cup or two a day that most Americans drink doesn’t seem to be enough. Researchers say 500 mg of caffeine, or about five cups of regular coffee, is the dose that seems to protect the brain.

Five Cups A Day

This may sound like an excessive amount of caffeine. After five cups, lots of us would end up with the jitters and be making extra trips to the bathroom. But some coffee lovers are hard core:

“I drink five to six cups a day religiously,” says Gary Arendash, a researcher at the Florida Alzheimer’s Disease Research Center, part of Florida State University. Arendash says he’s convinced that caffeine is protecting his brain.

Arendash and his colleagues at the Florida Alzheimer’s Disease Research Center have been studying the effects of caffeine on the brains of mice with Alzheimer’s disease. They’ve found that adding caffeinated water to rodents’ diet results in big improvements. The mice perform better on short-term memory and thinking tests. But only if they get enough caffeine.

“The human equivalent of two to three cups of coffee does not have benefits in our Alzheimer’s mice,” says Arendash.

Arendash’s team also documented that these super-caffeinated mice end up with about a 50-percent reduction in abnormal amyloid proteins, which are thought to play an important role in the development of Alzheimer’s.

The typical American drinks about a cup and a half of coffee a day. “So you can see that many of us are below that threshold level that we believe confers protective benefits,” says Arendash.

Evidence Not Conclusive

The Alzheimer’s mice studies on caffeine are intriguing to researchers who are trying to translate the findings into advice for humans. But interpreting an animal study can be tricky.

“It’s always a good starting point,” says Joan Lindsay of the University of Ottawa. “But we never know how well it’s going to hold up with humans.” After all, people are a lot more complicated. And researchers have learned that mice can respond really differently than humans do to a drug, an environmental toxin or a change in nutrition.

Another challenge is to find a reliable test of the memory of mice. Arendash uses a mouse maze to assess the spatial memory of his Alzheimer’s mice. He puts the mice in little swimming pools with lots of alleys and dead-ends to see how quickly they can find and remember hidden escape platforms. Similar computer-based maze tests are used in human studies.

“The first thing that is lost in Alzheimer’s is short term memory — the memory for what happened a few seconds or a minute ago,” says Arendash. “That’s what (the water maze) is focusing on.”

Observations Of Coffee-Loving Middle-Aged Folks

There wouldn’t be as much interest in Arendash’s mice studies if scientists hadn’t also begun to gather some evidence that a steady caffeine habit is beneficial to people, too.

One recent study comes from Finland where researchers followed about 1,400 coffee drinkers for more than two decades. Researchers found one group seemed to benefit the most: the people who’d been drinking three to five cups of coffee a day in their 40s and 50s.

“They had about a 65-to-70-percent reduced risk of developing Alzheimer’s disease in their 70s,” says Huntington Potter, a neurobiologist at the University of South Florida. Potters says effects held up even when researchers controlled for things such as cardiovascular disease, which can influence the risk of dementia.

A few other smaller studies in Europe have led to similar findings, but experts say the research only establishes a correlation between coffee drinking and brain protection.

“I’d hesitate to say that there’s epidemiologic evidence that coffee prevents Alzheimer’s disease,” says Reisa Sperling, an Alzheimer’s researcher at the Brigham and Women’s Hospital at Harvard University.

It’s possible that these regular coffee drinkers might have other habits in common that could explain the protective effect. “People who are very active in mid-life are more likely to be drinking coffee than couch potatoes,” says Sperling. Maybe the coffee drinkers aren’t benefiting from the coffee as much as they are from keeping their minds and bodies active. The studies make it difficult to suss out.

Coffee Drinking Can’t Offset Genetic Risks

Sperling says Alzheimer’s is an incredibly complicated disease. Exercise and good nutrition do seem to be protective, but a person’s risk is largely determined by genes. No one behavior or diet change — like coffee drinking — can erase that risk.

If future research brings stronger evidence that caffeine may modify the risk by some small percentage that means coffee lovers will have one more reason to drink away.

Just make sure those five cups don’t keep you up all night — sleep is important to health, too.

SOURCE: www.npr.org

Someday clinicians may gaze into the eyes of patients to determine if they have evidence of a classic sign of Alzheimer’s disease: plaque. Scientists have found the plaque that accumulates in the brain of people with Alzheimer’s disease also builds up in the retina, and it can be seen earlier than in the brain.

Although there is no cure for Alzheimer’s disease, researchers are always looking for ways to detect it early so individuals can take immediate steps to slow progression of the disease. A variety of early diagnostic efforts are underway, including the identification of certain biomarkers in the cerebrospinal fluid, and an x-ray technique that can “see” the amyloid plaques in the brain, which current imaging techniques are unable to do.

In fact, because there are no noninvasive brain-imaging techniques that can adequately identify amyloid plaques, the only way to definitively diagnose Alzheimer’s disease is at autopsy.

This newest approach was initiated after scientists at Cedars-Sinai Medical Center, along with colleagues from the Weizmann Institute of Science in Israel and the University of Southern California, found amyloid plaques in the retinas from deceased Alzheimer’s patients. They then used a noninvasive eye exam to examine the retinas of live mice that had been genetically modified to have Alzheimer’s disease.

The researchers found they could detect plaques in the retinas of the genetically modified mice before the plaque appeared in the brain. The high-resolution optical imaging technique they developed to monitor the plaque in the mice is an adaptation of an existing system used to examine the eyes of rodents.

Curcumin, a natural component of the spice turmeric, was used to label and detect plaque in the retinas. The curcumin attaches itself to amyloid plaques and makes them visible when viewed microscopically. The scientists chose the retina as a target for noninvasive imaging because it is easy to observe, and, unlike other parts of the eye, it is part of the central nervous system and has direct connection with the brain.

The authors believe these and other observations made during their studies establish the potential of an eye imaging technique as a tool for diagnosis of early Alzheimer’s disease via plaque on the retina.

SOURCE:
Cedars-Sinai Medical Center news release, June 24, 2010

Stimulating the brain with magnetic pulses might help people with Alzheimer’s disease improve their use of language, new research suggests. However, this treatment is still highly experimental and has been tested on very few people.

What do we know already?

Alzheimer’s disease affects more than 400,000 people in the UK. Over time, it damages people’s ability to think, remember things, and use language. There are several drugs that can slow down the progress of the disease, but there’s no cure, and most treatments have fairly small effects. Alzheimer’s charities stress the importance of practical support to help patients and carers cope, and to help people live independently for as long as possible.

In recent years, researchers have developed techniques that use magnetic pulses to influence the electrical activity in people’s brains. The magnetic pulses travel through the skull, so there’s no need for surgery.

Small-scale studies have looked at using magnetic stimulation for several conditions, including migraine, Parkinson’s disease, and depression. A new study has now looked at magnetic stimulation as a treatment for people with Alzheimer’s disease.

What does the new study say?

People who had magnetic stimulation showed a small, short-term improvement in their ability to use language.

For two weeks, half the people in the study had magnetic stimulation, and the other half had sham treatment with an inactive device. People had five sessions a week, each one lasting 25 minutes.

Over the two weeks, people who’d had magnetic stimulation improved their scores on a language test looking at sentence comprehension. The average starting score was 67, which increased to 77 after treatment. People who had sham stimulation scored an average of 66 points at the start of the study, and didn’t improve over the two weeks.

It’s worth noting that the people in the study took a whole battery of tests, looking at things like their mental state, their ability to name objects in a picture, a writing test, and a test looking at how well they performed their day-to-day activities. The sentence comprehension test was the only one where people showed an improvement.

After the first two weeks, both groups were given another two weeks of treatment, and this time everyone had real magnetic stimulation. The people who’d started with sham treatment caught up with the people who’d had real magnetic stimulation from the start, but there was no additional improvement among people who’d had the real treatment all along.

People continued getting higher scores in the language test in week 12 of the study, eight weeks after they’d finished treatment.

How reliable is the research?

The findings come from a small, preliminary study looking at just 10 people. While there seemed to be some improvement in language ability, there were no improvements in memory or in people’s ability to make decisions or do everyday things. So, it’s debatable just how much of a difference this treatment would make to people’s day-to-day lives.

Where does the study come from?

The study was done in Italy and appeared in the Journal of Neurology, Neurosurgery, and Psychiatry, published by the BMJ Group.

Funding came from the Italian ministry of health and the Fatebenefratelli Association for Biomedical and Health Research.

What does this mean for me?

Alzheimer’s is a serious illness, and it can make life very difficult for patients and their carers. It’s natural to be hopeful about new treatments, but it’s likely to be some time before researchers fully investigate magnetic stimulation and can say confidently whether it works.

SOURCE:

Cotelli M, Calabria M, Manenti R, et al. Journal of Neurology, Neurosurgery, and Psychiatry (2010). doi:10.1136/jnnp.2009.197848

To read more, see our information on Alzheimer’s and other types of dementia.

© BMJ Publishing Group Limited (”BMJ Group”) 2010

GINA KOLATA, PHILADELPHIA

THERE is only one way to know for sure that a person has Alzheimer’s disease. A pathologist, examining the brain after death, would see microscopic black freckles – plaque – sticking to brain slices.

Without evidence of plaque, a person with memory loss cannot be diagnosed with the disease. There is no treatment to stop or slow the progress of Alzheimer’s, but every major drug company has new experimental drugs it hopes will work. The questions though, are who should be getting the drugs, and who really has Alzheimer’s or is developing it?

But findings of tests on hospice patients show that a start-up medical technology company may have overcome one of the biggest obstacles in diagnosing Alzheimer’s. It has developed a dye that allows brain scans to reveal the plaque building in the brains of people with the disease.

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The findings will be presented at an international meeting of the Alzheimer’s Association in Honolulu on July 11. But they must still be confirmed and approved by the US Food and Drug Administration.

Five years ago Dr Daniel Skovronsky left academia and formed Avid Radiopharmaceuticals in Philadelphia to pursue his idea for brain scans to show the telltale plaque.

He and his team had developed a dye that could get into the brain and stick to plaque. They labelled the dye with a commonly used radioactive tracer and used a PET scanner to directly see plaque in a living person’s brain.

If the findings hold up, it will mean that for the first time doctors would have a reliable way to diagnose the presence of Alzheimer’s in patients with memory problems.

And researchers would have a way to figure out whether drugs are slowing or halting the disease, a step that ”will change everyone’s thinking about Alzheimer’s in a dramatic way”, said Dr Michael Weiner of the University of California, San Francisco.

To test the procedure Dr Skovronsky’s team designed a study with hospice patients. They sought the patients’ permission to have scans while still alive and then brain autopsies after death to see if the scans showed just what a pathologist would see.

Some predicted his study would be impossible, but the FDA said it wanted proof the plaque on PET scans was the same as plaque in a brain autopsy. Finally, on May 14, 35 patients had been scanned and autopsied. The Avid study was complete.

”This is going to have a big impact on Alzheimer’s disease, guys,” Dr Skovronsky told his staff that day.

SOURCE: New York Times

By Mark Vavoulis

A study published in the Journal of Biological Chemistry has found that the compound found in red wine known as resveratrol has the ability to neutralize the toxic effects of proteins linked to Alzheimer’s disease.

Researchers tested the effects of resveratrol on peptides that are associated with the plaque that forms in the brains of Alzheimer’s patients.

“We’ve shown how resveratrol has very interesting selectivity to target and neutralize a select set of toxic peptide isoforms,” said study author professor Peter Tessier of Rensselaer Polytechnic Institute. “Because resveratrol picks out the clumps of peptides that are bad and leaves alone the ones that are benign, it helps us to think about the structural differences between the peptide isoforms.”

Tessier said that the research provides a step toward understanding the large-scale death of brain cells seen in certain neurodegenerative diseases.

Alzheimer’s disease currently impacts more than 5 million Americans.

The disease is often treated by both traditional drugs, vitamins and minerals. One study found that high doses of vitamin E supplements could help alleviate Alzheimer’s symptoms.

Resveratrol is one of the active, non-alcholic ingredients in red wine. It comes from the pulp of grapes used to make wine and has some of the highest levels of antioxidants found in nature.

Among its believed health benefits are increasing heart health, fighting cancer and delaying the aging process.

SOURCE: www.drcutler.com

KARLSRUHE, Germany–(BUSINESS WIRE)–For the very first time, a medicine has been shown to protect against the development of Alzheimer’s disease. French scientists were able to demonstrate that taking 240 mg of Ginkgo extract EGb 761® per day regularly over a period of at least 4 years can cut the risk of developing Alzheimer’s disease by nearly 50%.

“The results of the GuidAge study are remarkable”, according to Prof. Michael Habs, Managing Director at Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, producers of EGb 761® (Tebonin®, pharmacy only). “It is the first time ever that a protective effect against Alzheimer’s disease has been demonstrated for a medicine. The multifaceted effects of the plant extract appear to positively influence the complex developmental processes of dementia.”

The GuidAge study was a large-scale study, in which 2854 elderly people with memory complaints were randomly assigned to receive either 240 mg/day of the patented Ginkgo special extract or a placebo for five years. Of those subjects taking the study medication for at least 4 years 29 out of 966 (3.0 %) taking placebo developed Alzheimer’s disease; in contrast only 15 out of 947 (1.6 %) treated with EGb 761® developed the disease (p=0.03) (Press release IPSEN, June 22, 2010). The result of this prospectively planned analysis shows that the Ginkgo special extract developed by Dr. Willmar Schwabe Pharmaceuticals can lower the risk of dementia by 47%.

The brain pathology that leads to overt Alzheimer’s disease develops over the course of many years. It is therefore not surprising that those study participants who developed dementia early in the study gained less protective benefit from EGb 761® treatment, because they already had the disease. When these subjects as well as those who left the study prematurely, i.e. all study participants were included in the analysis, the overall treatment effect was still detectable, although not statistically significant.

The results were commented on as follows by Prof. Ralf Ihl, University of Duesseldorf and director of the Department of Geriatric Psychiatry, Maria-Hilf Hospital, Krefeld: „There have been hints that Ginkgo biloba may exert a preventive effect. With the findings of this study we have first scientifically verifiable results suggesting that the extract may be useful for preventing the development of Alzheimer’s disease.“

The result of the GuidAge study agrees with the findings of two earlier cohort studies carried out in France, which also suggested a protective effect of EGb 761®. A study funded by the US National Institute on Aging as well found a dementia-protective effect in those subjects, who had taken their medication regularly. In another US study, a protective effect was not found, however. But towards the end of this study, the medicine was actually only taken by little more than half of the subjects. The results of the GuidAge study now again confirm the importance of a regular and long enough intake of 240 mg EGb 761® per day: A very high proportion of 93% of the participants took their medication regularly during the whole treatment period. Once again the excellent long-term safety profile of EGb 761® was confirmed.

Animal models also showed that EGb 761® intervenes in several of the processes decisive to the development of Alzheimer’s disease: the formation of harmful protein-compounds (so-called β-amyloid) is inhibited and the nerve cell damage caused by these as well as by ageing processes reduced so that energy generation in the nerve cells can be maintained. The patented special extract EGb 761® contains a particularly high proportion of plant substances that are unique to Ginkgo, ginkgolides and bilobalide, and that are especially important for the protection of nerve cells.

The efficacy of EGb 761® in the treatment of dementia diseases has been confirmed recently in several meta-analyses of available studies. EGb 761® can also improve cognitive performance in people who do not yet show significant impairment. In summarizing the study results, Dr. Reiner Kaschel, reader in clinical neuropsychology at the University of Osnabruck, concluded: “Meta-analyses of the data by independent scientists consistently substantiate the efficacy of EGb 761® at the onset of cognitive decline.”

Tebonin® is an phytopharmaceutical for the treatment of decreasing mental capacity. It contains the patented Ginkgo special extract EGb 761®, developed and manufactured by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe. EGb 761® is widely recognized as the best researched phytopharmaceutical world-wide and is available in more than 80 countries.

Dr. Willmar Schwabe Pharmaceuticals is a world leader in the development and production of plant-based pharmaceuticals. The Group, with its headquarters in Karlsruhe, employs around 3,700 staff across five continents.

SOURCE: www.businesswire.com

The jury is out on the balance of benefit and harm from testing for dementia that results from an incurable disease

By Lindsey Konkel

Alzheimer’s disease and its associated dementia can be a scary prospect for individuals and families faced with it. Between 2.4 million and 4.5 million Americans suffer from this debilitating, incurable disease, according to the National Institutes of Health. That figure is expected to rise as the baby boomers age.

Community memory screening events are becoming increasingly popular as individuals and their families seek to detect dementia in its earliest stages—before it destroys patients’ memories and thinking skills. But many physicians warn against these screenings, which are often ineffective when it comes to detecting dementia, and can leave test-takers feeling scared and powerless.

There are thousands of memory screening tests available, some self-administered online, some given in the community by health care professionals—usually in the form of a questionnaire. The Alzheimer’s Foundation of America, the advocacy group that funds National Memory Screening Day, promotes screenings overseen by health care professionals only.

“If someone goes online and does a self test, even if there are two pages of explanation of the results, I’m not sure that people understand what they are reading,” says Eric Hall, the foundation’s president and founder.

Hall says a health care professional can explain what a negative result on a memory test means and educate the individual and family members on what type of questions to ask the doctor. Most importantly, Hall says, a health care professional is there to emphasize that a negative result on a memory test is not an Alzheimer’s disease diagnosis but simply means the individual should to go to a doctor for follow-up tests.

On the other hand, the U.S. Preventive Services Task Force (USPSTF), an independent panel of government experts that assesses the effectiveness of clinical services, such as memory screenings, has found insufficient evidence to support routine dementia testing in older adults. According to the USPSTF, screenings are only sometimes effective when it comes to detecting the cognitive impairment associated with dementia. And because treatment for Alzheimer’s is limited, the task force found no evidence that the quality of life benefits of catching it early with memory screening outweigh the psychological stress of being labeled with an incurable disease.

“We should not screen for a disease we cannot effectively treat. If we could prevent Alzheimer’s disease then it would be very important for us to identify people in the earliest stages,” says Charles DeCarli, head of the Alzheimer’s Disease Center at the University of California, Davis. DeCarli does not screen for dementia, but says he would if there was a therapy that could cure or effectively manage the disease.

Along with the logic of dementia screening, DeCarli and other physicians question the efficacy of memory screening tests themselves. For every seven people that come to DeCarli’s office after failing a memory-screening test, only one is diagnosed with dementia. “There are many reasons to fail a screening test,” he says. “The person may be nervous, or they could be on a medication that impairs their memory.”

Memory screening tests are not good indicators of dementia because they offer only a snapshot of someone’s mental abilities, says John Morris, director of the Alzheimer’s Disease Research Center at the Washington University in St. Louis School of Medicine. Dementia is characterized by a change in a person’s cognitive abilities over time. “If you go to a community center and take a memory test, it doesn’t say whether you would have scored better or the same a year ago. Screening doesn’t tell us if people are changing,” Morris says.

Memory tests may also be limited in terms of detecting dementia in ethnic minorities, says Jed Levine, executive vice president of the Alzheimer’s Association–New York City Chapter, an advocacy group. For individuals who speak English as a second language, not understanding some of the words on a questionnaire or not understanding the instructions may lead to a failed test even if there is no problem with the person’s mind.

So what should you do if you’ve noticed a decline in your own memory or the cognitive abilities of a relative or friend? Seek a physician who has experience diagnosing dementia and who works with dementia patients—your primary care doctor, a geriatrician, geriatric psychologist or a neurologist, Miller says.

When assessing a patient for dementia, the physician will run a battery of tests—from questionnaires to brain scans. Most importantly, Miller notes, the physician will sit down with someone who knows the patient well—usually a spouse, adult, child or neighbor—and interview them about any changes that have taken place in the patient’s memory that are beginning to interfere with daily life. Most often, people with dementia are unaware that they are changing, according to Miller, who says that a close relation can usually give the best indication of changes in a person’s ability to remember things over time.

Failing a memory screening test, on the other hand, makes people scared about a disease they may but probably do not have, DeCarli says—and without a full physician’s assessment, there is no reliable way of knowing whether someone has Alzheimer’s or not.

This article is provided by Scienceline, a project of New York University’s Science, Health and Environmental Reporting Program.

SOURCE: www.scientificamerican.com