Thus, some experts in this controversial field are advocating that such a study be done with bapi.
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The belief is that in these trials bapi was administered to patients whose disease had progressed too far.
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We hypothesize the reason bapi may not have worked may have been due to dosing and different site of action vs. sola.
But I was not prepared for the broad criticism of the companies that took the chance to advance bapi into late stage development.
Surprisingly, there was also a fair degree of criticism that these companies had taken the risk of running late stage studies with bapi.
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The reason for this criticism was that the mid-stage clinical trials with bapi gave equivocal results and plunging into phase 3 was highly risky.
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When the mid-stage clinical results (phase 2) with bapi were disclosed by Wyeth (this occurred before the Pfizer acquisition), the efficacy signal was mixed.
Vung's father was a Christian evangelist in a village called Bapi.
While I had no part in the bapi discussions, I have been a part of such discussions over the years, and they go something like this.
These people, who are doing their utmost to help find any treatment for this disease, would have been outraged had bapi been dropped at phase 2.
While this drug clearly lowered the biomarkers of AD, the clinical trials also showed that bapi caused fluid build-up and bleeding in the brain, as well as seizures.
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Given that bapi seems to be effective in lowering AD biomarkers such as beta amyloid and phospho-tau, perhaps bapi needs to be administered to patients at an earlier stage.
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Back in 2008, many of the leading experts in AD strongly believed in the science behind bapi and they would have been quite negative about ending the bapi program.
This is not the final word on bapi, however.
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Personally, I would pass on further studies with bapi.
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Finally, dropping bapi would have caused public relations damage.
If bapi is doing what it is supposed to in terms of reducing the levels of beta amyloid and phospho-tau, and yet not improving cognition nor reversing brain shrinkage, perhaps the whole amyloid hypothesis is flawed.
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