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Paul Aisen on Biogen/Eisai Halt Phase 3 Aducanumab Trials

COMMENT This is terribly disappointing; a major blow to the field. Aducanumab was the leading AD therapeutic program, and a source of hope for everyone. We now need to evaluate the trial data to learn all we can and determine the implications for the field. It is ...

Paul Aisen on There’s No Tomorrow for TOMMORROW

COMMENT It is always very disappointing when a major effort to test an intervention aiming to slow the AD process ends without evidence of efficacy. I am sure that a full analysis of the data collected will nonetheless advance the field; we always learn from ...

Paul Aisen on Merck Pulls Plug on Phase 2/3 BACE Inhibitor Trial

COMMENT This is very disappointing. But for a BACE inhibitor in particular, earlier intervention is likely critical. If AD is an amyloid brain disease (an oversimplification), then BACE inhibition would be expected to prevent the disease. But reducing Aβ ...

Paul Aisen on Lessons from a failed γ-secretase Alzheimer trial.

COMMENT This excellent article by Bart de Strooper discusses the implications of the negative Phase 3 trial of Semagacestat in mild to moderate AD that led to discontinuation of the development of this compound. He points out that the once-daily regimen studied ...

Paul Aisen on Safety Concerns Halt ADAPT Trial

COMMENT Without seeing the data, I cannot comment on the decision to halt ADAPT. But note that in 2000, the VIGOR trial showed greater risk of MI [myocardial infarction] with rofecoxib than naproxen (triggering concern about COX-2 inhibitors and cardiovascular ...

Paul Aisen on Merck Withdraws Vioxx®

COMMENT What impact does Merck's withdrawal of rofecoxib have on AD patients? Some AD patients have been taking rofecoxib and other NSAIDs to treat the AD. There is little justification for this. Each large trial of rofecoxib for the treatment of AD or MCI ...

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