How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful?

 
• By Brenda Sandburg
  
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US FDA agrees with Eisai/Biogen that half a point change in cognitive scale, which sponsor says means a five month delay in decline, is a clinically meaningful benefit. But others contend the treatment effect is small and does not outweigh risk of brain bleeds.

Alzheimer's disease progression
Some question whether delay in cognitive decline in those receiving Alzheimer's drug Leqembi is clinically meaningful • Source: Shutterstock

The US Food and Drug Administration strongly backed Eisai Co., Ltd.’s conclusion that a Phase III study of Leqembi (lecanemab-irmb) demonstrated the clinical benefit of the drug for treatment of Alzheimer’s disease and a six-member advisory committee agreed. But there is some debate in the medical community as to whether a half of a point difference on a cognition scale, or a five month delay in decline, is clinically meaningful.

The members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had no reservations about the drug’s clinical efficacy....

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