Jun 30, 2008

Myriad Genetics Reports Results of U.S. Phase 3 Trial of Flurizan™ in Alzheimer's Disease

Flurizan Fails to Achieve Significance on Either Co-Primary Endpoint; Company Has Decided to Discontinue Its Development of Flurizan

Myriad Genetics today announced results of the Act-Earli-AD trial, an 18-month Phase 3 study of Flurizan (tarenflurbil) in patients with mild Alzheimer's disease. The study did not achieve statistical significance on either of its primary endpoints -- cognition and activities of daily living.

"We are disappointed that Flurizan failed to achieve significance in this study, and we will now discontinue development of this compound," said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. "The discontinuation of Flurizan will reduce our pharmaceutical development spend substantially and should enable Myriad to achieve profitability next year, ending June 30, 2009."

During fiscal 2008, Myriad spent approximately $60 million on development of Flurizan. The remaining expenses to wrap up its Flurizan program are projected to be approximately $8 million in total, spread primarily over the next two fiscal quarters.

Myriad to End Development of Flurizan

clipped from www.thestreet.com

Myriad Genetics MYGN said Monday that it will stop development of its experimental Alzheimer's disease drug Flurizan due to the failure of a pivotal phase III study.

The Flurizan study, which enrolled patients with mild to moderate Alzheimer's, did not achieve statistical significance on either of its two primary endpoints -- cognition or activities of daily living, the company said.

While disappointing, the negative outcome from the Flurizan study was not unexpected, given the relatively poor results coming out of the drug's phase II study.
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Jun 27, 2008

Myriad Genetics' Alzheimer's Disease Drug Mechanism of Action Detailed in Nature Article

"The article in Nature adds to the understanding of the mechanism of action of Flurizan, providing a molecular basis for its ability to slow the progression of Alzheimer's disease, as was demonstrated in previous human clinical studies"

Myriad Genetics' Alzheimer's Disease Drug Mechanism of Action Detailed in Nature Article

Myriad Genetics, Inc. (NASDAQ: MYGN) announced today that the mechanism of action of Flurizan(R) (tarenflurbil) -- its drug candidate for the treatment of Alzheimer's disease, is elucidated in the scientific journal Nature. The article, "Substrate-targeting Gamma-secretase Modulators," will be published in the June 12, 2008 issue of Nature.

Previous studies, in vitro, in animal models and in humans, have demonstrated that Flurizan selectively lowers toxic amyloid beta 42, and is the first member of a new class of drugs known as selective amyloid lowering agents (SALAs). Further, Flurizan has been shown to modify the processing of the amyloid precursor protein (APP) by the gamma secretase enzyme. The specific way in which Flurizan accomplishes this reduction in the toxic amyloid beta 42 had remained a mystery until now.

The Nature paper confirms the SALA properties of Flurizan and establishes the mechanism by which Flurizan modulates the APP-gamma secretase interaction. The authors demonstrate that the molecular target of Flurizan is the amyloid precursor protein itself -- the substrate of gamma secretase. Flurizan modifies the conformation of the APP molecule as it is bound to the gamma secretase complex. This change in the shape and/or position of APP in the complex results in cleavage by gamma secretase that produces shorter length, non-toxic amyloid beta fragments, such as amyloid beta 38 and amyloid beta 40. This exciting finding is novel in that most drugs target enzymes, blocking their function directly, but the substrate of an enzyme has not generally been seen as a drug target. These new findings are consistent with previous studies that show that Flurizan selectively lowers amyloid beta 42 by shifting the conformation of the APP/gamma secretase complex through allosteric binding.

"The article in Nature adds to the understanding of the mechanism of action of Flurizan, providing a molecular basis for its ability to slow the progression of Alzheimer's disease, as was demonstrated in previous human clinical studies," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The findings help explain why compounds like Flurizan can have a dramatic effect on lowering amyloid beta 42, the initiator of plaque formation in the human brain, and offer hope for the treatment of patients who suffer from Alzheimer's disease."

Flurizan U.S. Phase 3 Clinical Trial

Flurizan has recently completed a Phase 3 clinical trial in the U.S. of 1684 patients from 131 investigator sites. Topline data from the trial is scheduled for reporting in June 2008, and a full analysis of the data will be presented at the Alzheimer's Association's International Conference on Alzheimer's Disease in Chicago on July 29, 2008.

Flurizan is a registered trademark of Myriad Genetics, Inc. in the United States and other countries.

Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.

Jun 26, 2008

Overuse Of Antipsychotics Among Nursing Home Residents With Dementia

This excellent article really got my blood flowing. It reminded me about a similar situation that occurred with my mother's personal physician. The doctor wanted to put my mother on an anti-depression drug. I was far enough in and had read enough information about dementia and Alzheimer's to understand this was a bad idea. At that point we did change physicians (three times in fact).

It turned out that my mother was likely suffering from Alzheimer's and she needed Aricept. It also turned out she was suffering from unrecognized hypothyroidism, although this diagnosis came later.

I learned two very important lessons. First, once dementia is diagnosed you need to find a personal physician that understands the disease and is well educated about the appropriate actions that need to be taken. Second, I learned that every person suffering from dementia should have their thyroid checked. After almost two years of never smiling and laughing, my mother began to smile and laugh after she received the proper medication for her thyroid.

My mother actually sang the other day for the first time in several years. I believe the introduction of the thyroid medication is partly responsible for this very positive change.
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The clip below is a snippet of the article that appeared in the New York Times. Click the link in the clip to read the entire article. It is important. Please share this information with others.
clipped from www.nytimes.com

Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication.

Last fall her mother, Theresa Lamascola, of the Bronx, suffering from anxiety and confusion, was put on the antipsychotic drug Risperdal. When she had trouble walking, her daughter took her to another doctor — the younger Ms. Lamascola’s own physician — who found that she had unrecognized hypothyroidism, a disorder that can contribute to dementia.

Theresa Lamascola was moved to a nursing home to get these problems under control. But things only got worse. “My mother was screaming and out of it, drooling on herself and twitching,” said Ms. Lamascola, a pediatric nurse. The psychiatrist in the nursing home stopped the Risperdal, which can cause twitching and vocal tics, and prescribed a sedative and two other antipsychotics.

“I knew the drugs were doing this to her,” her daughter said. “I told him to stop the medications and stay away from Mom.”

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Also See;

Abnormal Thyroid Levels Can Increase Risk For Alzheimer’s Disease in Women

Jun 25, 2008

Early Alzheimer's patients speak up for others

"It's labeled incurable and you end up being a vegetable. People think as soon as you're labeled that way, you are. A lot of us aren't," says Hayen, 74, a retired San Diego physician who joined about 30 other early-stage Alzheimer's patients last month for a lobbying blitz at the nation's capital.

Follow the link in the clip below to read this interesting story.
clipped from www.msnbc.msn.com
Don Hayen has a handy way of deflecting the instant pity that comes when he reveals his Alzheimer's disease: "But I haven't lost my keys all day," he quickly jokes.

Hayen is part of a growing new movement in Alzheimer's: Patients diagnosed early enough to still be articulate and demand better care and better research. They are giving a voice to a disease whose victims until now have remained largely silent, and powerless.

It is a shift with big ramifications.

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Scientists identify possible Alzheimer's gene

As some of you know, I am always looking for information about genes that predispose individuals to Alzheimer's. If you are genetically predisposed to Alzheimer's by birth you might consider taking calcium or increasing your calcium intake.
Gene hampers cell's ability to absorb calcium, raises risk by 45 percent
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Scientists identify possible Alzheimer's gene

Scientists have identified a gene that may raise the risk of getting the most common kind of Alzheimer's disease by about 45 percent in people who inherit a certain form of it.

That form of the gene appears to hamper a brain cell's ability to take in calcium, researchers said. If drugs can be found that reverse its effect, they may be useful in fighting Alzheimer's, researchers said.

Most cases of Alzheimer's appear after age 65. So far, only one gene has been firmly established as affecting the risk of this late-onset version. The gene proposed in the new study, called CALHM1, appears to have a much smaller impact on the disease risk.

Dozens of other genes are also under study as possibly affecting risk of the disease.

The new work appears Friday's issue of the journal Cell. The work is reported by Philippe Marambaud of the Feinstein Institute for Medical Research in Manhasset, N.Y., and others in the United States and elsewhere.

They studied the gene with data from more than 2,000 people with Alzheimer's and about 1,400 people without the disease.

Bob DeMarco is a citizen journalist, blogger, and Caregiver. In addition to being an experienced writer he taught at the University of Georgia , was an Associate Director and Limited Partner at Bear Stearns, the CEO of IP Group, and a mentor. Bob currently resides in Delray Beach, FL where he cares for his mother, Dorothy, who suffers from Alzheimer's disease. He has written more than 500 articles with more than 11,000 links to his work on the Internet. His content has been syndicated on Reuters, the Wall Street Journal, Fox News, Pluck, Blog Critics, and a growing list of newspaper websites. Bob is actively seeking syndication and writing assignments.

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Alzheimer Disease Behavioral Symptoms Protocols

I found this very informative and valuable handout for caregivers on the Indiana University Center for Aging Research website. The opening webpage is titled Alzheimer Disease Behavioral Symptoms Protocols. On the right hand side of the page you will see a link entitled View Behavioral Symptoms Protocols and this will take you to the handout. If you prefer you can get to the PDF by clicking on this link, Behavioral Symptoms Protocols.

Please pass this information and link on to others. 

Alzheimer’s Disease as a Case of Brake Failure?

If you are like me you will find this research promising. When I read many of these research articles I experience feelings of hope and then frustration. It is clear this won't help my mother who suffers from Alzheimer's. At the same time, I am hopeful that it will help future sufferers of this sinister disease.

“It changes the logic from a search for a trigger that kicks off the dementia to the failure of a safety that has suppressed it”

Jun 24, 2008

Pfizer and the International Conference on Alzheimer’s Disease

Pfizer Invites Public to View and Listen to Webcast of July 28 Pfizer Analyst and Investor Meeting at ICAD
clipped from www.pfizer.com

NEW YORK--(BUSINESS WIRE)--Pfizer Inc invites investors, media, and the general public to view and
listen to a webcast of a presentation by Pfizers
neuroscience leadership team at an analyst and investor meeting on
Monday, July 28, at 6:00 p.m. Central Daylight Saving Time, in
connection with the annual meeting of the International Conference on
Alzheimers Disease (ICAD).

To view and listen to the webcast, visit our web site homepage at www.pfizer.com
and click on the Pfizer Analyst and Investor
Meeting at ICAD link in the Investor
Presentations tab. Information on accessing and pre-registering for the
webcast will be available at www.pfizer.com
beginning today.

Visitors will be able to view and listen to an archived copy of the
webcast at www.pfizer.com.

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New drug may mitigate Alzheimer's disease


The researchers discovered the medicine, CNI-14493, can transform amyloid into a form that doesn't aggregate to form plaques in the brain and also neutralizes the toxicity of the amyloid.

In his latest work, al-Abed was looking for a way to target the amyloid plaques that clump together between neurons in the brains of people with Alzheimer's disease.

Al-Abed, along with Michael Bacher and Richard Dodel of Marburg University in Germany, found the amyloid burden in the brain was reduced by 70 percent to 85 percent in areas hard hit in Alzheimer's patients -- the cortex and the hippocampus.

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Jun 19, 2008

The Doctor Will See You on the Webcam Now

Depending on cost this might work very well for people without health insurance. Many illnesses require a simple prescription for an antibiotic.

Many people I know can't get into a doctor on the first day when they start feeling ill. As a result, the lack of immediate treatment and a prescription drug causes the illness to linger and lengthens the recovery time.

This is an interesting counterpoint to retail clinics and behind the counter generic antibiotics.
clipped from blogs.wsj.com
To the Health Blog, American Well sounds like a company that’s selling doctor visits via webcam. But Roy Schoenberg, the CEO, tells us we don’t get it.
“The fact that you can engage in a Web video chat with a provider is a nice exercise, but it’s not the fundamental offering of the system,” is how he put it in a recent conversation.

The company’s business model is to partner with insurers, who agree to reimburse in-network doctors for patient e-visits. Docs who choose to work with American Well can sign on whenever they want and see patients who are looking for an online visit.

Today, the company announced its first big customer: HMSA, Hawaii’s Blue Cross Blue Shield provider, which has just under a million members and is the state’s biggest insurer.

The visits are reimbursed through relatively new standardized billing codes that allow docs to get paid for electronic visits. The insurer pays the doc, and American Well takes a cut. The company also charges an up-front licensing fee.

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Molecular Imaging Sheds New Light On Progression Of Alzheimer's Disease

The groundbreaking discovery by University of Pittsburgh researchers Chester Mathis, PhD, and William Klunk, MD, PhD, is being watched with great interest.

Pittsburgh Compound B (PIB) binds to the abnormal amyloid plaque in the brain. When imaged with a PET scan, PIB shows researchers actual pathological changes in the brain that could turn out to be the best and earliest signs of the disease.

Jun 18, 2008


This inforamtion about grape seed extract and MegaNatural-AZ. is new to me and I thought I would pass it along.

Since I am genetically predisposed to Alzheimer's via birth I am always searching for information and alternatives that might be beneficial in the long run.
clipped from www.sfn.org
A compound found in grape seed extract reduces plaque formation and resulting cognitive impairment in an animal model of Alzheimer’s disease, new research shows. The study appears in the June 18 issue of The Journal of Neuroscience.

The researchers tested a grape seed polyphenolic extract product sold as MegaNatural-AZ, made by Polyphenolics, which in part supported the study. Polyphenolic compounds are antioxidants naturally found in wine, tea, chocolate, and some fruits and vegetables. To determine whether the extract could mitigate the effects of Alzheimer’s disease, the researchers used mice genetically modified to develop a condition similar to Alzheimer’s disease. They exposed pre-symptomatic “Alzheimer’s mice” to the extract or placebo daily for five months. The daily dose of the polyphenolic extract was equivalent to the average amount of polyphenolics consumed by a person on a daily basis.

Fish Oil Pinch Spurs Search for Alternative Omega 3

I guess we can expect prices for Omega-3 to start rising fast soon. My mother and I take three capsules each every day so cost could become an issue at some point.

As for genetically modified Omega-3, I guess we will make the decision when the new products become available.
clipped from blogs.wsj.com
The global commodities boom extends even to the ocean depths: The price of crude fish oil has nearly tripled in the past five years.
This matters to you, Health Blog reader, because fish oil is a primary source of omega-3 fatty acids, the nutritional supplements that may reduce the risk of heart disease and a host of other ailments.

The price has been rising as Baby Boomers (and others) have been swallowing ever more fish oil. Global fisheries, alas, are already under pressure and can’t keep up with the habit.

Responding to this growing imbalance, some big corporate players are using biotech gene-splicing techniques to create land-based supplies of omega-3s, Dow Jones Newswires reports.

DuPont hopes to use genetically modified yeast to crank out omega-3s. Monsanto is trying soy beans. And Dow AgroSciences and Martek Biosciences are splicing algae genes into canola seeds. The products could come to market within the next few years.

A Doctor’s Lessons From a Dying Patient

Sometimes patients know they’re about to die. Doctors, accustomed to saving lives rather than passively awaiting death, don’t always handle those situations all that well.

clipped from blogs.wsj.com
“Even though death is an inevitable part of the human condition, it’s not something that most doctors, including me, ever get too comfortable with,” family doc Ben Brewer writes this week in his WSJ column. “We get used to pushing it off until another day.”
Brewer writes, the final few days of a patients life can be illuminating for doctors who make the time. He describes the last days of a 95-year-old patient who came down with pneumonia.
The patient took to telling stories of his youth. He described visiting Germany with his family as a young man, during the 1930s. At one point, as he was walking down a deserted street, he encountered a soldier who stopped, raised his hand and said, “Heil Hitler.”
My patient, who wasn’t Jewish but wasn’t saying “Heil Hitler” to anybody, affected a broad smile, and replied, “Good morning,” as pleasantly as he could. He kept walking without looking back and wondered if he would still have his head as he passed by. He survived unharmed.

Jun 17, 2008

Ben Bernanke: ‘Disturbing Gap’ in American Health Care

clipped from blogs.wsj.com

The question for economists isn’t whether the country is spending too much on health care, Ben Bernanke said today. “Rather, the question, whatever we spend, is whether we are getting our money’s worth.”

While Bernanke said there’s much to praise about American health care, he also said we could get more for our money. “The evidence … suggests that the cost of health care in the United States is greater than necessary to allow us to achieve the levels of health and longevity we now enjoy,” he said. “Although some patients do not receive the care they need, others receive more (and more expensive) care than necessary.”
He was speaking at a Senate committee hearing on health reform; the text of his speech is online here.
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Study Shows Alzheimer's Drug Bapineuzumab effective in some patients

clipped from online.wsj.com
Pharmaceutical partners Wyeth and Elan Corp. said Tuesday results from a highly anticipated midstage study of their experimental Alzheimer's disease drug bapineuzumab show the treatment appears to be effective in some patients.

Bapineuzumab didn't show a statistically significant difference compared with placebo in all patients, but the companies said it suggested a trend toward improving cognitive function.

Bapineuzumab is designed to work by attacking a substance in the brain called beta-amyloid. There is a growing scientific consensus that a buildup of beta-amyloid is responsible for Alzheimer's.

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Change in Depressive Symptoms During the Prodromal Phase of Alzheimer Disease

Those who developed AD (n = 190) showed no increase in depressive symptoms before the diagnosis was made, and this finding was not modified by age, sex, education, memory complaints, vascular burden, or personality. There was no systematic change in depressive symptoms after the AD diagnosis, although symptoms tended to decrease in women relative to men and in those with a higher premorbid level of openness and a lower premorbid level of agreeableness. Among those without cognitive impairment at baseline, depressive symptoms did not increase in those who subsequently developed mild cognitive impairment.
Conclusion  We found no evidence of an increase in depressive symptoms during the prodromal phase of AD.
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Ginkgo biloba does not help people with dementia, study finds

Ginkgo biloba has no benefit for people with dementia, according to new Alzheimer's Society research.

One of the longest and most rigorous studies yet on Ginkgo biloba found it does not slow progression of dementia and does not significantly effect cognitive function or quality of life.

The study was the first to test the effects of Gingko biloba on people with dementia in a community setting in the UK and showed no significant benefit over a  six month period. 176 people with mild-moderate dementia took part in the placebo-controlled trial. Ahead of print publication, the study is now available for 'early viewing' on the International Journal of Geriatric Psychiatry online.

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Jun 15, 2008

I broke down on live TV over my dad's Alzheimer's

The article on the following page is important and uplifting. I remember during those first few months of caring for my mother how sad and frustrated I was feeling. Then, I met a young couple in the gym that had gone through the entire experience from beginning to end with their mother who suffered and died from Alzheimer's disease.

I remember as I related my own experience to them how they shook their heads up and down indicating they knew exactly what I was experiencing. They recounted their similar experiences and always with a smile on their face. I remember feeling immediately "I was not alone". The feelings of frustration, fear and sadness dissipated and I now find myself thinking, "I can do it".

'Alzheimer's is such a cruel disease because that vibrant person is taken away from you. They are still there in body but it's like the shell. The person you remember has gone.'

Jun 14, 2008

Scientists: 115-year-old's brain worked perfectly

clipped from www.msnbc.msn.com
A Dutch woman who was the oldest person in the world when she died at age 115 in 2005 appeared sharp right up to the end, joking that pickled herring was the secret to her longevity.

Scientists say that Henrikje van Andel-Schipper's mind was probably as good as it seemed: a post-mortem analysis of her brain revealed few signs of Alzheimer's or other diseases commonly associated with a decline in mental ability in old age.

That came as something of a surprise, said Gert Holstege, a professor at Groningen University, whose findings will be published in the August edition of Neurobiology of Aging.

Hendrikje van Andel-Schipper was the world's oldest living person at the time of her death at age 115 in 2005. She is seen here the year before she died at de Westerkim, home for the elderly, in Hoogeveen, Netherlands.
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Jun 13, 2008

Alzheimer's disease supersedes diabetes as sixth-leading cause of death in the United States

clipped from www.actionalz.org

Alzheimer's disease is now the sixth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics. The CDC estimates that 72,914 Americans died of Alzheimer's disease in 2006. With an unprecedented historic population shift of 78 million aging baby boomers in the country and this disease poised to strike 10 million boomers - it is clear this escalating epidemic must be addressed now.

"The CDC's announcement that Alzheimer's disease jumped from the seventh to the sixth-leading cause of death should serve as a wake-up call to the nation," said William Thies, Ph.D., vice president of Medical and Scientific Relations at the Alzheimer's Association. "The fact that there are no effective treatments for Alzheimer's has allowed the disease to pass diabetes. It is vitally important that we increase Alzheimer's research funding to slow or stop the progression of this devastating disease."

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Jun 12, 2008

Alzheimer's Society Comment On A News Strategy For Carers That Plans To Double The Amount Of Respite Care For Carers In England

The carers strategy is a good start in tackling the large set of problems faced by carers. Greater investment in respite is very good news. It could give thousands of carers the invaluable opportunity to recharge their batteries and access crucial support. However, it's important that this new money is used for short breaks and not only given to people when they reach crisis point. It's also not just about putting someone in a care home for a week, we need to get creative and provide support that fits people's individual needs.

The Alzheimer's Society provides a national help line on 0845 3000 336 and website http://www.alzheimers.org.uk. Please include this information in any publication that uses these comments.
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Jun 11, 2008

Promising drug fights Alzheimer's in three ways

One GSM drug now being tested in people with Alzheimer's is Myriad Genetics's Flurizan, also called tarenflurbil.
clipped from www.msnbc.msn.com
A type of drug that may offer promise in treating Alzheimer's disease works in three ways to fight the formation of "plaques" in the brain that are a hallmark of the ailment, scientists said on Wednesday.
The researchers looked at a kind of drug called a gamma-secretase modulator, or GSM, now being tested to see if it slows Alzheimer's disease progression.

Results from a Flurizan study involving 1,600 people with Alzheimer's are expected this summer, Golde said.

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Bright lights slow dementia patients’ decline

My mother often tries to sit in a dark room. I find that sunlight from windows and brighter lamps at night brighten her miood.
clipped from www.msnbc.msn.com
Brightening the lights for elderly people with dementia, in combination with a daily dose of the sleep hormone melatonin, improved their mood, sleep, and overall well-being, Dutch researchers said on Tuesday.
"The strong point of our findings was that effects were so prominent over a wide range of measurements of different aspects of functioning, suggesting a very strong improvement of the quality of life," said Eus van Someren of the Netherlands Institute for Neuroscience, in Amsterdam.
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Gene variation linked to earlier onset of Alzheimer's symptoms

clipped from mednews.wustl.edu
Investigators at Washington University School of Medicine in St. Louis have identified a genetic variation associated with an earlier age of onset in Alzheimer's disease.
Unlike genetic mutations previously linked to rare, inherited forms of early-onset Alzheimer's disease — which can strike people as young as their 30s or 40s — these variants influence an earlier presentation of symptoms in people affected by the more common, late-onset form of the disease.
"We focused on this gene for two reasons: First, it codes for the tau protein that we find in neurofibrillary tangles, and secondly, some studies in the scientific literature show an association between the gene and Alzheimer's disease, while others do not," says principal investigator Alison M. Goate
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Quick Quiz helps Doctors distinguish Dementia from forgetfullness

clipped from medschool.wustl.edu

A 3-minute quiz that asks patients about recent changes in memory is helping physicians differentiate signs of mild dementia from plain forgetfulness, a new study shows. The quiz was developed by neurologist James Galvin. More  >
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A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION)

Follow the link to Clinical Trials.gov for additional information and available locations.
clipped from clinicaltrials.gov
Alzheimer's Disease
Phase III

This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening MMSE.
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