Showing posts with label clinical trial. Show all posts
Showing posts with label clinical trial. Show all posts

Tuesday, July 31, 2012

Doctors criticize IViG therapy for dementis


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Here is a great dementia resource for caregivers and healthcare professinals,


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The Dementia Caregiver's Little Book of Hope [Kindle Edition

ABC News

Doctors Criticize IViG Study Results

Still, treatment is not advised for patients who have had a major stroke or heart attack, because it can increase the risk of vascular events.
IVIG may not just be a therapy that treats symptoms, according to Dr. Richard Caselli, a neurologist at the Mayo Clinic. The drug seems to block the "destructive process" of inflammation mechanisms in the brain.
"Its strength and therefore importance is that it seems to show a stabilizing effect over a sustained period of time," he said. "Its weakness as the authors state is the small number of patients as well as its unblinded open label format."
But Dr. Normal Foster at the Center for Alzheimer's Care, Imaging and Research at the University of Utah, said the selective reporting of the study's results are "suspicious."
"Not everyone who received treatment was included in the analysis," he said. "The results are intriguing, and I can see why they might want to share them, but they can't be relied upon."
Dr. James E. Galvin, director of the the Pearl Barlow Center for Memory Evaluation and Treatment at New York University's Langone Medical Center, said there may be "technical and logistical limitations" in how many patients might obtain the drug.
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But Dr. Sam Gandy, director of Mount Sinai Center for Cognitive Health, said the study, though small, is "still good news, indeed."
He, like other experts, said more studies were needed to prove the drug's promise.
Marder showed no symptoms of the disease in his speech, memory or mood when interviewed by ABCNews.com. He said he first began noticing he was having trouble with his memory a decade ago.
"I thought it was all part of aging," he said.
After a series of tests with a neurologist that were inconclusive, he was preventively put on the drug Aricept. But within a matter of months, an official diagnosis of Alzheimer's disease was made.
"I was devastated," he said. "It blows you away."
As his confusion and forgetfulness worsened, Marder was put on Namenda, as well as Aricept, both of which he has continued for nine years.
Every six months Relkin puts Marder through a series of cognitive tests and so far, the decline has been minimal.
But now, the Marders worry that they may not get the drug if it does not get FDA approval when phase III clinical trials end next year.
And it's expensive – estimated to cost a patient $2,000 to $5,000 every two weeks, including the drug, equipment and a nurse to administer it.
Relkin has told the Marders there were other drugs, but Marder said, "I just want them to keep going."
Marder continues to play tennis and can ride his bike up the 11-mile stretch from Battery Park to the George Washington Bridge -- and back.
"He still has memory issues, no question," said his wife. He tends to repeat himself, but the drug has kept him stable. "There's no doubt he has Alzheimer's, but we would have expected him to progress downward by now."
Luckily, Marder has the self-awareness to know what the drug has done for him.
"It's heaven," he said. "I don't know where I could have been without it.

Sunday, July 29, 2012

IViG therapy shows some success for treating dementia


Caregivers, and healthcare professionals, here is some great information


Here is a great dementia resource for caregivers and healthcare professinals,


Your residents will love the Amazon Kindle Fire


Here is information on being the best caregiver you can be


Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two


Follow alzheimersideas on twitter

The Dementia Caregiver's Little Book of Hope [Kindle Edition

ABC News


Jason Marder watched the inevitable decline of his younger brother, who died of Alzheimer's disease at the age of 50. Then, just after his 60th birthday, he too, began to exhibit subtle, early symptoms -- forgetfulness and difficulty focusing on conversations.
At his birthday party, "I noticed he had a hard time keeping track of the presents," said he wife, Karin Marder. "He would forget small things -- like saying he went to the movies when he didn't."
The memory loss progressed, and in 2004, Marder got the dreaded diagnosis: Alzheimer's, a disease that affects 5.1 million Americans.
"It was devastating," said his wife, who works in business apparel. "I thought our lives were going to end."
But today, eight years after his diagnosis, Marder isn't any worse off. He has shown no further memory loss and has remained stable.
The Marders credit intravenous immunoglobulin, or IViG, therapy and a clinical trial that is swirling in controversy this week after an announcement of study results by the Alzheimer's Association International Conference 2012 in Vancouver.
Some doctors hailed the therapy as "exciting," something that could potentially stabilize the disease, while others said the research is inconclusive and the study -- with only 16 subjects -- was too small.
Nonetheless, today Marder, now retired from working in apparel, continues his independent lifestyle, playing tennis and biking in his native New York City.
"Things are going really nicely. I can't complain," said Marder, now 70. "I don't feel any going backwards."
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"This drug saved his life," said Karin Marder. "He's independent. He gets on the subways, bikes up and down the Hudson River, gets to go out with friends. He goes to the senior center twice a week. He does creative writing."
For the past five years, Marder has been part of a clinical trial with Dr. Norman R. Relkin, director of the Memory Disorders Program at New York-Presbyterian/Weill Cornell Medical Center.
Relkin presented data that found,overall, that 11 study participants who received the immunotherapy Gammagard (IViG) for three full years showed improvements in cognition, memory, daily functioning and mood.
"We are seeing encouraging results," Relkin told ABCNews.com. And despite negative publicity, "I don't want people to give up hope for symptomatic treatment of the disease".
Intravenous Immunoglobulin is a mixture that contains molecules pooled from plasma, a component of human blood. It is used to treat various autoimmune, infectious and idiopathic diseases, and its supply is therefore limited.
IViG works by using the body's natural defense or immune system and anti-amyloid antibodies. A protein called beta amyloid accumulates in the brain of those who have Alzheimer's.
"We don't know exactly what it targets, but we do know it contains all antibodies that the body produces," said Relkin. "It alters the function of the immune system and decreases inflammation in the brain".
He said that his research team found the rate of brain shrinkage had slowed and the study had "exceeded criteria" to go forward with a phase III trial.
"Typically, untreated Alzheimer's disease shows cognitive decline in three to six months," said Relkin. "Those treated with typical AD drugs show decline in six to nine months. Four out of four patients in the [phase IIB] extension trial were unchanged over a three-year period."
As for Marder, he still has some memory problems, but he can dress himself, cook, clean and walk around the neighborhood.
"I can be away from him for one to two nights," said his wife, Karin.
Every two weeks, a nurse comes to Marder's home and sets up the infusion, which takes about four hours.
"I am happy to spend the time," he said. "Then I walk out of my house and go bike riding."
Besides a minor rash that crops up three to five days after getting the drug, Marder has had no ill side effects with the treatment. "He hasn't even had a cold in five years," said Marder's wife.

Saturday, June 25, 2011

Testosterone Therapy Improves Memory in Post-menopausal Women

Here is a great dementia resource for caregivers and healthcare professinals,

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care professionals to get an easyceu or two

Here are more interesting dementia brain boosting activities



Newswise — Post-menopausal women have better memory after daily treatment with a testosterone spray for six months, a new preliminary study finds. The results will be presented Saturday at The Endocrine Society’s 93rd Annual Meeting in Boston.

“Women have a higher risk of developing dementia compared to men,” said Sonia Davison, MD, PhD, the study’s lead investigator and a postdoctoral research fellow at Monash University, Melbourne. “These results offer a potential therapy, where none currently exists, to slow cognitive decline in women.”

The researchers compared a control group of 30 women who received no treatment with a group of nine healthy women in early menopause (ages 47 to 60) who knowingly received the testosterone spray on their skin. The spray dose returned testosterone levels in the blood to those typical of young women of childbearing age, according to Davison. All of the treated women were receiving a stable dose of non-oral hormone replacement therapy.

All women underwent testing of cognitive function with a battery of computerized tests that can detect even small changes in cognitive performance, Davison said. The researchers tested subjects’ memory through their ability to recall items from a grocery list read aloud to them—a test of verbal learning and memory—and through their performance on tests of visual learning and memory. Cognitive testing occurred at the beginning and end (week 26) of the study.

At the start of the study the two groups did not differ significantly in their cognitive test results. After 26 weeks the untreated controls showed no significant differences between their initial and final test results, the authors found. The testosterone-treated group, however, improved their verbal learning and memory, as found on the shopping list test, Davison reported.

“This is exciting in that the testosterone-treated women were all healthy, with no cognitive impairment, and there was a definite treatment effect of the testosterone spray,” Davison said. “Testosterone may play a protective role against dementia.”

She said their results need confirmation in a randomized, controlled clinical trial.

The following organizations helped finance this study: the National Health and Medical Research Council of Australia, the Royal Australasian College of Physicians Research and Education Foundation (Vincent Fairfax Family Foundation fellowship) and FemPharm in Australia, which makes the testosterone spray for women.

Saturday, October 30, 2010

Potential New Alzheimer's Drug Shows Promise

Here is a great dementia resource for caregivers and healthcare professinals,

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care professionals to get an easyceu or two

Here are more interesting dementia brain boosting activities





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Intellect Neuroscience announced that a Phase 1b clinical trial of OXIGON (OX1) showed that this Alzheimer’s drug is safe and well tolerated at all dosages.

OX1 is a potential treatment for Alzheimer’s disease. It inhibits the activity of beta amyloid acids. These acids are a type of amino acid that is thought to be related to the development of harmful protein plaques found in Alzheimer's disease patients. This drug,OX1, has also been shown to protect

Read more about Potential New Alzheimer's Drug Shows Promise

Tuesday, July 6, 2010

ICARA study: Bapineuzumab

Here is a great dementia resource for caregivers and healthcare professinals,

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care professionals to get an easyceu or two

Here are more interesting dementia brain boosting activities





Get your subscription to Activity Director Today's e magazine

The goal of the ICARA (Bapi) study is to determine if an investigational drug, called bapineuzumab, can help slow the progression of Alzheimer's disease.

Current therapies for Alzheimer's treat the symptoms associated with it, not the disease itself.

It is important for patients and families affected by Alzheimer's to consider participating in clinical studies.

A medical team, including a physician, will monitor participants throughout the study.

There is no charge to participate in this study.

To find out more about bapineuzumab
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