Neuroscience
From the FDA last week:
FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease
FOR IMMEDIATE RELEASE
P06-168
October 13, 2006
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The Food and Drug Administration (FDA) today approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease.
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
"Alzheimer's Disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "Today's approval makes available another treatment for those with severe dementia."
FDA approved Aricept to treat patients with mild to moderate Alzheimer's Disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo. Today's approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's Disease.
In these studies, the effectiveness of treatment with Aricept was determined by evaluating the patients' cognitive functions such as memory, language, orientation and attention, as well as their overall functioning. The results showed that patients on Aricept performed better on both measures compared to placebo.
Aricept is manufactured by Eisai Inc., Teaneck, N.J.
-
Anthony H. Risser | neuroscience | neuropsychology | brain
- Alzheimer's Disease: Gammagard Fails
From the company press release: Baxter Announces Topline Results of Phase III Study of Immunoglobulin for Alzheimer's Disease DEERFIELD, Ill., May 7, 2013 - Baxter International Inc. (NYSE:BAX) today announced that its Phase III clinical study of...
- Neuropsychology Abstract Of The Day: Alzheimer Drug Regimens & Delivery Systems
Bassil, N & Grossberg, GT. (2009). Novel regimens and delivery systems in the pharmacological treatment of Alzheimer's disease. CNS Drugs, 23(4), 293-307. The mainstay of current management of patients with Alzheimer's disease involves drugs that...
- Abstract Of The Day: Alzheimer Disease Drug Treatments
Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25; (1): CD005593. BACKGROUND: Since the introduction of the first cholinesterase inhibitor (ChEI) in 1997, most clinicians and probably most patients...
- Abstract Of The Day: Donepezil (aricept) And Alzheimer Disease
Csernansky JG, Wang L, Miller JP, Galvin JE, & Morris JC. Neuroanatomical predictors of response to donepezil therapy in patients with dementia. Archives of Neurology. 2005 Nov; 62(11): 1718-1722. Alzheimer's Disease Research Center, and Department...
- Reminyl (galantamine Hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug By ANDREW POLLACK New York Times Published: January 22, 2005 Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated...
Neuroscience
FDA: Alzheimer Disease, Aricept (donepezil hydrochloride)
From the FDA last week:
FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease
FOR IMMEDIATE RELEASE
P06-168
October 13, 2006
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The Food and Drug Administration (FDA) today approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease.
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
"Alzheimer's Disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "Today's approval makes available another treatment for those with severe dementia."
FDA approved Aricept to treat patients with mild to moderate Alzheimer's Disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo. Today's approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's Disease.
In these studies, the effectiveness of treatment with Aricept was determined by evaluating the patients' cognitive functions such as memory, language, orientation and attention, as well as their overall functioning. The results showed that patients on Aricept performed better on both measures compared to placebo.
Aricept is manufactured by Eisai Inc., Teaneck, N.J.
-
Anthony H. Risser | neuroscience | neuropsychology | brain
- Alzheimer's Disease: Gammagard Fails
From the company press release: Baxter Announces Topline Results of Phase III Study of Immunoglobulin for Alzheimer's Disease DEERFIELD, Ill., May 7, 2013 - Baxter International Inc. (NYSE:BAX) today announced that its Phase III clinical study of...
- Neuropsychology Abstract Of The Day: Alzheimer Drug Regimens & Delivery Systems
Bassil, N & Grossberg, GT. (2009). Novel regimens and delivery systems in the pharmacological treatment of Alzheimer's disease. CNS Drugs, 23(4), 293-307. The mainstay of current management of patients with Alzheimer's disease involves drugs that...
- Abstract Of The Day: Alzheimer Disease Drug Treatments
Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25; (1): CD005593. BACKGROUND: Since the introduction of the first cholinesterase inhibitor (ChEI) in 1997, most clinicians and probably most patients...
- Abstract Of The Day: Donepezil (aricept) And Alzheimer Disease
Csernansky JG, Wang L, Miller JP, Galvin JE, & Morris JC. Neuroanatomical predictors of response to donepezil therapy in patients with dementia. Archives of Neurology. 2005 Nov; 62(11): 1718-1722. Alzheimer's Disease Research Center, and Department...
- Reminyl (galantamine Hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug By ANDREW POLLACK New York Times Published: January 22, 2005 Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated...