Tuesday, October 5, 2010

10/5 Disabled World

Disabled World
Safety of Diabetes Medication for Patients with Alzheimer's Disease
September 13, 2010 at 9:34 PM
By JAMA and Archives Journals
Published: 2010-09-13
Last Modified: 2010-10-04
Pilot study demonstrates safety of diabetes medication for patients with Alzheimer's disease.
* * *
A pilot study suggests the diabetes medication pioglitazone is generally well tolerated and may warrant further study as a treatment for patients with Alzheimer's disease, according to a report posted online today that will appear in the January 2011 print issue of Archives of Neurology, one of the JAMA/Archives journals.
"Alzheimer's disease is an immense and growing public health problem," the authors write as background information in the article. "Although prescription drug therapy for the symptoms of Alzheimer's disease has been available since 1993, these agents do not fundamentally alter the pathological expression of the disease or its progressive course. The failure of several recent treatment trials directed at the beta-amyloid peptide, a key pathological correlate of Alzheimer's disease, suggests a need to explore alternative approaches to Alzheimer's disease treatment that are not focused on beta-amyloid metabolism."
Another potential therapeutic target for the treatment of Alzheimer's disease is the nuclear receptor peroxisome proliferator–activated receptor gamma, PPAR-gamma, which acts to regulate glucose and lipid metabolism. A class of drugs known as thiazolidinediones, originally developed to reduce insulin resistance in patients with type 2 diabetes, are potent agonists (trigger a response) of PPAR-gamma. To evaluate the safety of one of these medications, pioglitazone, in patients without diabetes but with Alzheimer's disease, David S. Geldmacher, M.D., of the University of Virginia Health System, Charlottesville, and colleagues conducted an 18-month, double-blind, placebo-controlled randomized controlled trial. Twenty-nine patients without diabetes but with probable Alzheimer's disease were randomly assigned to receive either pioglitazone (titrated to 45 milligrams daily) or matching placebo, along with 200 international units of vitamin E.
A total of 25 patients (12 taking pioglitazone and 13 taking placebo) completed 18 months of therapy. Two of the patients who discontinued participation in the study early had a change in caregivers status, and two withdrew their consent; no discontinuations were attributed to adverse events.
Peripheral edema, swelling of the legs and feet, was the main adverse event, affecting four patients in the pioglitazone group (28.6 percent) compared with none in the placebo group. "This is consistent with the known adverse event profile of pioglitazone," the authors write. "No group differences in laboratory measures were identified."
"No significant treatment effect was observed on exploratory analysis of clinical efficacy," they continue, noting that the study was not intended to determine treatment efficacy. Based on the results of sample size analyses, the researchers estimate that a study would need to enroll between 155 and 340 participants randomly assigned to placebo or pioglitazone to find treatment effects for patients with Alzheimer's disease. Given that trials leading to Food and Drug Administration approval of current drugs typically enrolled 250 to 500 patients, and that several ongoing trials will enroll more than 1,000, further studies to assess the clinical efficacy of pioglitazone would be feasible.
"Disappointing results of treatment trials based on the amyloid hypothesis, and the reasonable degree of safety identified in this trial, suggest that exploratory studies of thiazolidinediones remain warranted," the authors conclude. "Future studies of this class should focus on earlier stages of disease progression and be augmented by biomarkers, such as nuclear imaging techniques, to measure changes in microglial activation associated with treatment."



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Thursday, September 30, 2010

Dr. Paul Greengard, Karolinska Institutet's Bicentennial Gold Medal Recipient

Fisher Center for Alzheimer's Research Foundation » Articles
Dr. Paul Greengard, Karolinska Institutet's Bicentennial Gold Medal Recipient
September 23, 2010 at 11:00 AM
Dr. Paul Greengard, Karolinska Institutet's Bicentennial Gold Medal Recipient
Dr. Paul Greengard, a Nobel Prize-winning neurobiologist and director of the Fisher Center for Alzheimer's Disease Research at The Rockefeller University, will receive the Karolinska Institutet's Bicentennial Gold Medal on September 23rd, 2010.  This medal is the highest award conferred by Karolinska Institutet during its 200th anniversary celebrations, and recognizes the work of an individual not permanently located at the Karolinska Institutet, who has contributed to the esteemed Swedish university's activities.  Since 1901, the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in Physiology or Medicine.
"Dr. Greengard is one of the most prominent scientists of this century." says Harriet Wallberg-Henriksson, President of Karolinska Institutet.  "His seminal work has revealed several of the mechanisms behind psychiatric diseases.  He has been a mentor for generations of Karolinska Institutet scientists, who have been inspired by his scientific leadership and by his extraordinary capacity to reveal the biological meaning and medical implications of a series of unexpected observations from the laboratory."
Dr. Greengard has authored over 1,000 major scientific publications, and on September 2, 2010, he published an article in the scientific journal Nature that has been lauded as a potential paradigm shift in how Alzheimer's will be studied, and possibly treated, in the future. The article, entitled "Gamma-secretase Activating Protein is a Therapeutic Target for Alzheimer's Disease," outlines the discovery of a protein in the brain that stimulates the production of beta-amyloid, a protein in the brain believed to be one of the biological causes of Alzheimer's disease.
Dr. Greengard is a member of the National Academy of Sciences and has received more than 50 awards and honors.  In 2000, Dr. Paul Greengard, together with his wife, the renowned sculptor, Ursula von Rydingsvard, used his Nobel Prize honorarium to fund the Pearl Meister Greengard Prize, an award for women scientists named in honor of Greengard's mother, Pearl Meister Greengard, who died giving birth to him. The award is to combat discrimination against women in science, since, as Greengard observed, "Women are not yet receiving awards and honors at a level commensurate with their achievements."
The Karolinska Institutet's Gold Medal will be presented to Greengard on September 23rd at the residence of the Swedish ambassador to the United States in Washington, D.C.
Mr. Kent L. Karosen, President and CEO of the Fisher Center for Alzheimer's Research Foundation adds, "On behalf of the Fisher Center Foundation, I want to congratulate Dr. Greengard on this very prestigious award.  Dr. Greengard's contribution to Alzheimer's research has shaped the course of modern investigation into the causes and possible treatment of the disease, and his recent findings continue to open new avenues of study.  We are honored to have such a world prominent scientist directing the work of our research center."
The Fisher Center for Alzheimer's Research Foundation is a leading source of funding for Alzheimer's research and education. We serve Alzheimer's patients and their families by seeking to understand the causes of, discover a cure for, and improve the lives of people with Alzheimer's disease.  Nobel laureate Dr. Paul Greengard directs the Foundation's team of internationally renowned scientists.  Of the money raised by the Foundation, only 8 cents out of every dollar is used for overhead and administrative purposes.  For more information about the Fisher Center for Alzheimer's Research Foundation, visit www.ALZinfo.org
Contact:
Betsey Odell:  betsey@alzinfo.org, 646-381-5148



Sunday, September 26, 2010

9/26 Disabled World

Disabled World
Safety of Diabetes Medication for Patients with Alzheimer's Disease
September 13, 2010 at 9:34 PM
By JAMA and Archives Journals
Published: 2010-09-13
Last Modified: 2010-09-24
Pilot study demonstrates safety of diabetes medication for patients with Alzheimer's disease.
* * *
A pilot study suggests the diabetes medication pioglitazone is generally well tolerated and may warrant further study as a treatment for patients with Alzheimer's disease, according to a report posted online today that will appear in the January 2011 print issue of Archives of Neurology, one of the JAMA/Archives journals.
"Alzheimer's disease is an immense and growing public health problem," the authors write as background information in the article. "Although prescription drug therapy for the symptoms of Alzheimer's disease has been available since 1993, these agents do not fundamentally alter the pathological expression of the disease or its progressive course. The failure of several recent treatment trials directed at the beta-amyloid peptide, a key pathological correlate of Alzheimer's disease, suggests a need to explore alternative approaches to Alzheimer's disease treatment that are not focused on beta-amyloid metabolism."
Another potential therapeutic target for the treatment of Alzheimer's disease is the nuclear receptor peroxisome proliferator–activated receptor gamma, PPAR-gamma, which acts to regulate glucose and lipid metabolism. A class of drugs known as thiazolidinediones, originally developed to reduce insulin resistance in patients with type 2 diabetes, are potent agonists (trigger a response) of PPAR-gamma. To evaluate the safety of one of these medications, pioglitazone, in patients without diabetes but with Alzheimer's disease, David S. Geldmacher, M.D., of the University of Virginia Health System, Charlottesville, and colleagues conducted an 18-month, double-blind, placebo-controlled randomized controlled trial. Twenty-nine patients without diabetes but with probable Alzheimer's disease were randomly assigned to receive either pioglitazone (titrated to 45 milligrams daily) or matching placebo, along with 200 international units of vitamin E.
A total of 25 patients (12 taking pioglitazone and 13 taking placebo) completed 18 months of therapy. Two of the patients who discontinued participation in the study early had a change in caregivers status, and two withdrew their consent; no discontinuations were attributed to adverse events.
Peripheral edema, swelling of the legs and feet, was the main adverse event, affecting four patients in the pioglitazone group (28.6 percent) compared with none in the placebo group. "This is consistent with the known adverse event profile of pioglitazone," the authors write. "No group differences in laboratory measures were identified."
"No significant treatment effect was observed on exploratory analysis of clinical efficacy," they continue, noting that the study was not intended to determine treatment efficacy. Based on the results of sample size analyses, the researchers estimate that a study would need to enroll between 155 and 340 participants randomly assigned to placebo or pioglitazone to find treatment effects for patients with Alzheimer's disease. Given that trials leading to Food and Drug Administration approval of current drugs typically enrolled 250 to 500 patients, and that several ongoing trials will enroll more than 1,000, further studies to assess the clinical efficacy of pioglitazone would be feasible.
"Disappointing results of treatment trials based on the amyloid hypothesis, and the reasonable degree of safety identified in this trial, suggest that exploratory studies of thiazolidinediones remain warranted," the authors conclude. "Future studies of this class should focus on earlier stages of disease progression and be augmented by biomarkers, such as nuclear imaging techniques, to measure changes in microglial activation associated with treatment."



Link To "Safety of Diabetes Medication for Patients with Alzheimer's Disease"


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