If all three drugs fail and fail miserably the Alzheimer's community is in trouble. The pharmaceutical companies might give up. They might conclude that Alzheimer's cannot be treated effectively.
By Bob DeMarco
Alzheimer's Reading Room
The Phase 3 clinical trials for Bapineuzumab and Solanezumab are scheduled to be released in the next few months, maybe as early as next month. A third drug, Gammagard, could report next year.
Some say if the drugs fail it could be the end of Alzheimer's research as we know it. That major pharmaceutical companies might out of frustration cut back on research spending for Alzheimer's disease.
Others, like Rudolph Tanzi, Director, Genetics and Aging Research Unit, MassGeneral Institute for Neurodegenerative Disease Harvard believe that even if the drugs fail that science is advancing. Tanzi believes that beta amyloid is "the prime therapeutic target" and that the drugs are bad, not the target. We need better drugs.
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We can only hope that one of the clinical trials is successful and an effective treatment is discovered. If not, hopefully something very positive will come our of the trials. Are the drugs hitting the target? We will find out soon.
A recent survey of institutional investors showed that investors are pessimistic. Only 21 percent expect Bapineuzumab to be successful. They gave Solanezumab only a 14 percent chance of meeting all its primary goals in the trial.
Pessimism is understandable, its been almost a decade since a clinical trial for Alzheimer's found success. Fourteen failed trials in a row.
The last drug to gain approval Namenda (Memantine) is approved for moderate to severe Alzheimer's. However, it is often prescribed early on in combination with Aricept (Donepezil).
This week we did get some encouraging news.
On Wednesday, scientists announced a finding, published in the journal Nature, that a single gene which causes the rare, early-onset form of Alzheimer’s disease can also carry a mutation that serves to protect against the disease.
Cure Alzheimer’s funded researcher Sam Gandy called the finding “extraordinarily important, the most significant in the field since researchers first reported a mutation that leads to the disease, 22 years ago. "These findings support drug development to modulate the amount of beta amyloid in the brain as a preventative for Alzheimer’s disease".
Bapineuzumab (bap-ih-NOOZ-uh-mab) is being developed by Pfizer Inc. and Johnson & Johnson’s Janssen Alzheimer Immunotherapy unit.
Solanezumab (sol-ah-NAYZ-uh-mab), is being developed Eli Lilly & Co.
Gammagard, is being developed by Baxter International Inc.
We will be getting a scientific update from the Alzheimer's Association International conference on Gammagard next week.
One thing is certain. If all three drugs fail and fail miserably the Alzheimer's community is in trouble. The pharmaceutical companies might give up. They might conclude that Alzheimer's cannot be treated effectively.
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Original content Bob DeMarco, the Alzheimer's Reading Room