F.D.A. Sees Promise in Alzheimer’s Imaging Drug

By GINA KOLATA, Published: January 20, 2011
An advisory committee to the Food and Drug Administration recommended unanimously Thursday that the agency approve the first test — a brain scan — that can show the characteristic plaques of Alzheimer’s disease in the brain of a living person. The approval was contingent on radiologists agreeing on what the scans say and doctors being trained in how to read the scans.

The F.D.A. usually follows advice from its advisory committees, and Alzheimer’s experts anticipated that the scans would be approved. The additional requirement would not be a big hurdle, said Dr. Daniel M. Skovronsky, chief executive of the company, Avid Radiopharmaceuticals, that applied to market the scans.

“We don’t know exactly what F.D.A. will want,” Dr. Skovronsky said. “But it should take months to generate this type of data, not years.”

The committee vote is “a very positive thing,” said Maria Carrillo, senior director of medical and scientific relations for the Alzheimer’s Association. “This is nothing but a positive for our families.”

More than five million Americans have Alzheimer’s disease.

Plaques are part of the criteria for having Alzheimer’s — if a person with memory problems does not have plaques, that person does not have Alzheimer’s. But without the scan, the only way to know if plaques were present is to do an autopsy.

Alzheimer’s specialists said they expected that if the scan were approved it would come into widespread use.

“This is a big deal,” said Dr. Pierre N. Tariot, director of the memory disorders center at the Banner Alzheimer’s Institute in Phoenix. Asked if he would be using the scans, Dr. Tariot replied, “Absolutely.” Read more at the NY Times Read More...

Tags: Food and Drug Administration, Gina Kolata, Daniel M. Skovronsky, Maria Corrillo, Avid Radiopharmaceuticals, Banner Alzheimer’s Institute, Dr. Pierre N. Tariot, Alzheimer's Associaton

Updated: Wednesday, 12 Jan 2011, 9:17 AM EST
Published : Wednesday, 12 Jan 2011, 8:58 AM EST

Alzheimer's disease currently affects four million Americans, and that number continues to grow. The good news is that the devastating disease is receiving a lot of attention from the medical community.

Researchers are making significant strides in detection, treatment and even prevention. Groundbreaking research is being conducted locally at the University of South Florida.

Jill Ardila, the administrator of clinical trials at USF, stopped by Good Day to explain some of the tests being done and how far the research into this illness has come.

To learn more about USF Health's Byrd Alzheimer's Institute, visit their website at health.usf.edu/nocms/byrd Read More...

Tags: clinical trials, USF-Byrd Alzheimer's Institute, Jill Ardila

“ScienceDaily (Dec. 30, 2010) — The aggregated proteins strewn about the brain are the hallmark of one of the most common neurodegenerative disorders: Alzheimer's disease. But while these irregular, gunky proteins, called amyloid-β, are believed to contribute to the deterioration of memory and cognitive ability in Alzheimer's patients, no one knows how they lead to these symptoms, and the severity of the dementia doesn't directly depend on the amount of amyloid-β plaques found in diseased brains.

New experiments from The Rockefeller University, building on a paper published earlier this year, show how amyloid-β interacts with a clotting agent in the blood, increasing blood clots that are harder than usual to break down and starving neurons of their regular supply of oxygen. The research suggests that the effects of amyloid-β on the blood vessels feeding the brain could be an important aspect of the havoc they wreak on the brain.

"There has been a suggestion that vascular dementia and Alzheimer's disease might be related, and our current work provides a possible connection between the two," says Sidney Strickland, head of the Laboratory of Neurobiology and Genetics at Rockefeller....” Read More at Science Daily Read More...

Tags: Blood Tests, Rockefeller University, Alzheimer's Disease Research Center

Insights Give Hope for New Attack on Alzheimer’s

NY Times Gina Kolata December 13, 2010

“Alzheimer’s researchers are obsessed with a small, sticky protein fragment, beta amyloid, that clumps into barnaclelike balls in the brains of patients with this degenerative neurological disease.

In this microscopic views of brain tissue, cortical gray matter is shown in yellow, with amyloid plaques appearing dark brown. A buildup of amyloid is the first sign of Alzheimer’s disease.
It is a normal protein. Everyone’s brain makes it. But the problem in Alzheimer’s is that it starts to accumulate into balls — plaques. The first sign the disease is developing — before there are any symptoms — is a buildup of amyloid. And for years, it seemed, the problem in Alzheimer’s was that brain cells were making too much of it.

But now, a surprising new study has found that that view appears to be wrong. It turns out that most people with Alzheimer’s seem to make perfectly normal amounts of amyloid. They just can’t get rid of it. It’s like an overflowing sink caused by a clogged drain instead of a faucet that does not turn off.

That discovery is part of a wave of unexpected findings that are enriching scientists’ views of the genesis of Alzheimer’s disease. In some cases, like the story of amyloid disposal, the work points to new ways to understand and attack the disease. If researchers could find a way to speed up disposal, perhaps they could slow down or halt the disease. Researchers have also found that amyloid, in its normal small amounts, seems to have a purpose in the brain — it may be acting like a circuit breaker to prevent nerve firing from getting out of control. But too much amyloid can shut down nerves, eventually leading to cell death. That means that if amyloid levels were reduced early in the disease, when excess amyloid is stunning nerve cells but has not yet killed them, the damage might be reversed.

Yet another line of research involves the brain’s default network: a system of cells that is always turned on at some level. It includes the hippocampus, the brain’s memory center, but also other areas, and is the brain’s mind-wandering mode — the part that is active when, for instance, you’re driving in your car and you start thinking about what you will make for dinner. That brain system, scientists find, is exactly the network that is attacked by Alzheimer’s, and protecting it in some way might help keep the brain healthier longer.

For example, during nondreaming sleep, ... “ Read More at the New York Times Read More...

Tags: Gina Kolata, Beta Amyloid

Passage of the National Alzheimer’s Project Act signals a recognition from the nation's leaders that a coordinated federal approach is necessary to confront one of America's most feared and costly disease. Read More in the Medical News and The Alzheimer’s Association and Contact the President to Sign this bill into law Read More...

Tags: National Alzheimer's Project Act, NAPA

Tampa, FL (Dec. 1, 2010) — Dynamic regulation of the chaperone protein Hsp27 was required to get rid of abnormally accumulating tau in the brains of mice genetically modified to develop the memory-choking tau tangles associated with Alzheimer’s disease, a University of South Florida-led study found.

Researchers at the USF Health Byrd Alzheimer’s Institute demonstrated that the effective switching of Hsp27 between its active and deactivated states was critical on two fronts — to promote the recycling of the tau protein in healthy nerve cells and to clear abnormal tau from the brain before the protein could clump together into the sticky tau neurofibrillary tangles that kill brain cells involved in memory formation. Their findings were published online Nov. 17, 2010 in the Journal of Neuroscience.

“Our study shows that Hsp 27 may be a double-edged sword depending upon the contextual environment of neurons in the brain,” said the study’s principal investigator Chad Dickey, PhD, associate professor of molecular medicine at USF Health. “By better defining the mechanisms linking chaperone proteins to both the tau aggregation and degradation pathways, we can move toward more individualized, effective therapies targeting Alzheimer’s and other distinct neurological disorders.” READ MORE ON THIS ARTICLE
Read More...

Tags: Tau Tangles

Alzheimer’s disease drugs available today help improve symptoms for some patients, but do not stop or delay the abnormal build-up of plaques in the brain – a hallmark of the neurodegenerative disease that destroys memory.

That may be about to change.

The 98 investigational medicines for Alzheimer’s disease and related dementias, either in clinical trials or awaiting FDA review, include promising prospects that target the disease’s underlying causes. Some have shown evidence of preventing new amyloid plaques from forming in the brain, while others appear to remove plaques already there.

“Right now is one of the most exciting times to be in the field Alzheimer’s disease research,” said David Morgan, PhD, CEO and director of the USF Health Byrd Alzheimer’s Institute. “Tremendous progress has been made by academic researchers, clinicians and the biopharmaceutical industry in working to come up with solutions to this memory-robbing disease.” READ MORE at UST HEALTH Read More...

Tags: Johnnie Byrd, Dr. David Morgan, USF-Byrd Alzheimer's Institute

Spinal-Fluid Test Is Found to Predict Alzheimer’s

NY Times By GINA KOLATA Published: August 9, 2010

“Researchers report that a spinal fluid test can be 100 percent accurate in identifying patients with significant memory loss who are on their way to developing Alzheimer’s disease.

Although there has been increasing evidence of the value of this and other tests in finding signs of Alzheimer’s, the study, which will appear Tuesday in the Archives of Neurology, shows how accurate they can be. The new result is one of a number of remarkable recent findings about Alzheimer’s.

After decades when nothing much seemed to be happening, when this progressive brain disease seemed untreatable and when its diagnosis could be confirmed only at autopsy, the field has suddenly woken up.

Alzheimer’s, medical experts now agree, starts a decade or more before people have symptoms. And by the time there are symptoms, it may be too late to save the brain. So the hope is to find good ways to identify people who are getting the disease, and use those people as subjects in studies to see how long it takes for symptoms to occur and in studies of drugs that may slow or stop the disease....” MORE FROM THE NEW YORK TIMES ON ALZHEIMER’S SPINAL FLUID TEST Read More...

Tags: spinal fluid test

Institute’s merger into USF Health represents “limitless” opportunity for research and treatment.

Some 18 months after the Byrd Institute merged into the USF Health system, three memory clinics are under one roof, as are labs conducting groundbreaking research into the nature of Alzheimer's. Now the Institute's clinicians and researchers are forming seamless teams to treat and someday cure the cruel, crippling and ultimately fatal disease that affects nearly a half-million Floridians. "Overall, it's been a resounding success," said Dr. Stephen K. Klasko, Sr. Vice President for USF Health and Dean of the USF College of Medicine. Achievements Since the Merger Klasko cited a number of achievements since the merger Read More...

Tags: Florida Alzheimer's Network, Memory Disorder Clinics, National Institutes of Health, Alzheimer's Disease Research Center