Novartis, Amgen and Banner Alzheimer’s Institute has announced that they are stopping two pivotal Phase Ⅱ/Ⅲ clinical trials in the Alzheimer’s Prevention Initiative Generation Program.
The trials were developed for evaluation of the BACE1 inhibitor CNP520 (umibecestat). During the scheduled review, unblinded data was analyzed; but the results were completely opposite. The conditions of the patients got even worse in some of the measurements of cognitive function.
The trials were halted because the BACE1 inhibitor did not showed the desired results. Beta-amyloid is the protein that is responsible for Alzheimer’s disease and BACE1 inhibitor only inhibits the BACE1 enzyme that helps in amyloid plaque formation. But, it failed to significantly decrease the amyloid protein or clear it. This is the reason, why further clinical studies were halted.
Trials were conducted by the Banner Alzheimer’s Institute in collaboration with the sponsors Amgen and Novartis. Novartis leads the regulatory sponsorship.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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