Post hoc findings from Ab immunotherapy clinical trials

Immunization with either Ap peptide or monoclonal antibodies raised against the Ap peptide is reported to block NP formation or to have a modest effect on reducing existing NP load in Ap-depositing transgenic mice [35]. Clinical trials involving active immunization with the Ap peptide were halted due to toxicity [36]. However, former subjects enrolled in the trial have continued to come to autopsy. Case studies suggested that some of these subjects may have experienced a lowering of amyloid load, yet showed a continuing decline in cognition [37]. These results have been used to argue that Ap deposition is not important in cognition. There are several caveats to this conclusion. First, these are uncontrolled post hoc analyses from an aborted clinical trial. Second, if there was in fact a clearance of amyloid load induced by an elevated titer of Ap antibodies, the timeframe over which this antibody titer formed and the clearance occurred is unknown. Third, it is not known in what temporal window Ap immu-notherapy needs to be administered to be clinically efficacious. If amyloid deposition is a triggering event for subsequent pathological events, we now know that the mild-to-moderate AD patient population is well past the point at which NPs form in brain. In sum, post hoc analysis of the original Ap immunotherapy trial is not able to test the "amyloid hypothesis" [32].

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