New Era Of Hope: Anti-Amyloid Alzhemed.
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Developing a new drug is a lengthy and expensive process that takes up to 15 years and on average costs 800 million US dollars. According to the Alzheimer's Association, only 5 out of 10,000 compounds investigated make it to clinical trials, and of those, only one makes it through to approval for treatment. And, in the case of Alzheimer's, there are added challenges; for example, the only definitive diagnosis at the moment involves sampling brain tissue.
Tramiprosate, brand name Alzhemed is an amyloid beta antagonist that is currently in Phase III clinical trials to assess its safety, efficacy and disease modifying effects in patients with mild to moderate Alzheimer's. Alzhemed binds to amyloid beta protein and interferes with its ability to build plaque and poison brain cells.
Dr Paul Aisen, Professor of Neurology and Medicine, and Director of the Memory Disorders Program at the Georgetown University Medical Center, Washington DC , and lead author presented the conference with an update of the trial. Unfortunately Aisen was unable to present any conclusions because there is a lot of complex data that is still being processed.
The key points were:
The randomized, double-blind, placebo controlled trial enrolled 1,052 patients from several medical centres in the US and Canada.
All patients were taking doses of acetylcholinesterase inhibitors, with or without memantine.
Patients took either the active drug or a placebo twice a day for 18 months and were assessed every three months. Assessments included tests of cognitive function, disability, clinical efficacy, and volumetric MRI to assess effect of the disease on brain volume. Apparently there are significant unexpected differences in the data coming from the various sites and these need to be accounted for before the results can be finalized.
Gandy said that while the results of the Alzhemed Phase III clinical trial were not available, there was a positive note: "We have learned important lessons about how to do these types of very complex, long-term, large-scale Alzheimer's trials, which in itself is very important because there are now so many promising Alzheimer's therapies in the pipeline," he explained.
Alzheimer's Donation
Donate Online Now
.
Developing a new drug is a lengthy and expensive process that takes up to 15 years and on average costs 800 million US dollars. According to the Alzheimer's Association, only 5 out of 10,000 compounds investigated make it to clinical trials, and of those, only one makes it through to approval for treatment. And, in the case of Alzheimer's, there are added challenges; for example, the only definitive diagnosis at the moment involves sampling brain tissue.
Tramiprosate, brand name Alzhemed is an amyloid beta antagonist that is currently in Phase III clinical trials to assess its safety, efficacy and disease modifying effects in patients with mild to moderate Alzheimer's. Alzhemed binds to amyloid beta protein and interferes with its ability to build plaque and poison brain cells.
Dr Paul Aisen, Professor of Neurology and Medicine, and Director of the Memory Disorders Program at the Georgetown University Medical Center, Washington DC , and lead author presented the conference with an update of the trial. Unfortunately Aisen was unable to present any conclusions because there is a lot of complex data that is still being processed.
The key points were:
The randomized, double-blind, placebo controlled trial enrolled 1,052 patients from several medical centres in the US and Canada.
All patients were taking doses of acetylcholinesterase inhibitors, with or without memantine.
Patients took either the active drug or a placebo twice a day for 18 months and were assessed every three months. Assessments included tests of cognitive function, disability, clinical efficacy, and volumetric MRI to assess effect of the disease on brain volume. Apparently there are significant unexpected differences in the data coming from the various sites and these need to be accounted for before the results can be finalized.
Gandy said that while the results of the Alzhemed Phase III clinical trial were not available, there was a positive note: "We have learned important lessons about how to do these types of very complex, long-term, large-scale Alzheimer's trials, which in itself is very important because there are now so many promising Alzheimer's therapies in the pipeline," he explained.
posted by Valery Yermalitsky at
9:13 AM
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