Questions for monoclonal antibodies (Aduhelm and Leqembi) for Alzheimer's.

JOURNAL ARTICLE
Key questions for the evaluation of anti-amyloid immunotherapies for Alzheimer’s disease 
Kathy Y Liu, Nicolas Villain, Scott Ayton, Sarah F Ackley, Vincent Planche, Robert Howard, Madhav Thambisetty
Brain Communications, Volume 5, Issue 3, 2023, fcad175, https://doi.org/10.1093/braincomms/fcad175
Published:
 
02 June 2023​

"questions over biases due to unblinding and differential drop out, as well as concerns about safety and clinical and cost-effectiveness remain."
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Comments:
Why this publication raised "questions over Biases due to unblinding....."?
Do they suspect the "double blind" clinical studies? Because the injection irritation locally and systemic side effects as FDA states “headache, confusion, dizziness, vision changes, nausea and seizure” or “risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure. “ All these will have obvious impacts on the patients (of course without for placebo control since lack of foreign proteins) and affect their end point evaluation psychologically. 

Everyone knows that Amyloid beta plaque reduction with PET measurement is not neccessary correlated to positive clinical results. So the double blind study control is absolutely critical.