Aducanumab: 4 in 10 high dose trial participants experienced brain swelling or bleeding

Acute Effects of Focused Ultrasound-Induced Blood-Brain Barrier Opening on Anti-Pyroglu3 Abeta Antibody Delivery and Immune Responses

“…Both active and passive immunizations are being explored and are at different stages of clinical trials [ 3 ]. The recent approval of aducanumab is under debate in the scientific community and the improvement in cognition was statistically significant in only a subset of patients who received the highest dose of aducanumab, a fully human IgG1 anti-amyloid monoclonal antibody (mAb) that binds plaque amyloid [ 4 ], while a subset of patients developed Amyloid related Imaging abnormalities (ARIA) with mostly transient and asymptomatic vasogenic edema and/or microhemorrhages [ 5 , 6 , 7 ]. Although controversial, the aducanumab clinical trials demonstrated that higher antibody exposure was associated with better biomarker changes and clinical outcomes [ 8 ].…”

Treatment effects on event-related EEG potentials and oscillations in Alzheimer's disease

“…Event-related EEG measures during oddball tasks may be helpful cognitive neurophysiological biomarkers for intervention clinical trials performed in individuals with AD (Güntekin et al, 2021). Previous studies confirm that validated neuroimaging and multimodal fluid AD biomarkers are significantly associated with event-related EEG responses during oddball tasks (Babiloni et al, 2020a, Babiloni et al, 2020b, 2021. It is well known that ERPs allow for the study of EEG activity phase-locked to sensory stimuli or motor responses during cognitive tasks.…”

“…In June 2021, the Food and Drug Administration (FDA) suggested Aduhelm (aducanumab) for the treatment of ADD as the first diseasemodifying drug (Knopman et al, 2021). However, the European Medicines Agency has recommended the refusal of a marketing authorization for Aduhelm due to concerns about safety and efficacy (Mahase, 2021). Therefore, there is an urgent need to identify and use biomarkers probing the neurophysiological underpinnings of human cognitive functions to test the clinical efficacy of that drug at the group level.…”

Top Alzheimer's disease risk allele frequencies differ in HABS‐HD Mexican‐ versus Non‐Hispanic White Americans

“…Currently, there is no curative treatment for AD that has proven effective. The most recent US Food and Drug Administration–approved medication (aducanumab) caused significant controversy due to extremely high cost, and adverse effects, ranging from brain swelling to brain hemorrhage being noted in 41% of patients during clinical trials 47–50 . Additionally, it has been noted that aducanumab studies contained under‐representation of diverse populations, adding further uncertainty to the safety in these population 51 .…”