Great news for Alzheimer patients and care givers. Leqembi approved for people with early Alzheimer Disease, those with Mild Cognitive Impairment or Mild Dementia (with confirmed amyloid plaques in their brains). All patients need to be tested for the APOE4 genotype because of the substantial safety risk of brain edema and hemorrhage.

The risk to people with two copies of the APOE4 mutation — about 15 percent of people with Alzheimer’s — is so high that the F.D.A.’s black-box warning recommends that all patients be genetically tested to assess their safety risk and spells out that those with two APOE4 copies are more vulnerable to developing “symptomatic, serious and severe” brain bleeding or swelling.

Overall a major step forward to AD patients, care givers and the Neurodegenerative Disease field.