Controversial Alzheimer’s drug highlights concerns about Health Canada approval process: Aducanumab was approved on the basis of what’s called a surrogate endpoint, which is a measurement that is supposed to reflect progression of a disease. In this case, the surrogate endpoint was the clearing of amyloid plaque — abnormal brain deposits often seen in Alzheimer’s patients — from the brains of those with Alzheimer’s. Aducanumab was successful in doing that, but it’s not the first drug that has been shown to clear plaque.

There have been more than 25 previous trials of plaque-clearing drugs and none of them showed any benefit for people with Alzheimer’s. One study followed elderly individuals with plaque and pathological changes typical of Alzheimer’s and found that they had no more cognitive decline that those with “normal” brains.

Controversial Alzheimer’s drug highlights concerns about Health Canada approval process: Aducanumab was approved on the basis of what’s called a surrogate endpoint, which is a measurement that is supposed to reflect progression of a disease. In this case, the surrogate endpoint was the clearing of amyloid plaque — abnormal brain deposits often seen in Alzheimer’s patients — from the brains of those with Alzheimer’s. Aducanumab was successful in doing that, but it’s not the first drug that has been shown to clear plaque.There have been more than 25 previous trials of plaque-clearing drugs and none of them showed any benefit for people with Alzheimer’s. One study followed elderly individuals with plaque and pathological changes typical of Alzheimer’s and found that they had no more cognitive decline that those with “normal” brains.Read More