aducanumab

08/09/2023 - "Is Aducanumab treatment developed to prevent progression of Alzheimer's disease cost-effective in Turkey?"
08/01/2021 - "Aducanumab as a Novel Treatment for Alzheimer's Disease: A Decade of Hope, Controversies, and the Future."
04/01/2023 - "Correction to: Characterization of exposure-Clinical Dementia Rating-Sum of Boxes relationship in subjects with early Alzheimer's disease from the aducanumab Phase 3 trials."
01/01/2023 - "EMERGE and ENGAGE were randomized, placebo-controlled, Phase 3 trials of aducanumab in participants with early Alzheimer's disease. "
01/01/2023 - "A recent Phase III development program for aducanumab in Alzheimer's disease was halted based on a pre-defined futility guideline, yet based upon updated data and closer examination, the terminated studies became the basis for a regulatory submission. "

12/14/2016 - "Acute topical application of aducanumab to the brain resulted in clearance of amyloid plaques. "
01/01/2022 - "Aducanumab (targeting amyloid plaques), which recently received FDA accelerated approval, had one positive and one negative phase 3 trial. "
07/01/2021 - "This decision was achieved through the Accelerated Approval Pathway and was essentially motivated by the evidence that aducanumab reduces brain amyloid plaques. "
01/01/2023 - "Food and Drug Administration-approved drugs such as aducanumab, as well as upcoming newer-generation drugs, have provided an exciting new therapy focused on reducing the amyloid plaque burden in AD. "
12/01/2021 - "Aducanumab is the first AD therapy approved by the US Food and Drug Administration to reduce a defining pathophysiological feature of the disease, brain amyloid plaques. "

01/01/2022 - "•Controversial registration of aducanumab for Alzheimer's Disease•Aducanumab is the subject of post-licensing observational studies aiming to follow the effects of the drug•Given the high prevalence of cerebrovascular pathology it is important that these studies do not ignore vascular cognitive disorders•The studies may give detailed phenotyping data that may lead to knowledge of targets for treatments of patients with vascular cognitive disorders."
10/26/2021 - "Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment."
01/01/2021 - "Aducanumab's efficacy as a treatment for the cognitive dysfunction in Alzheimer's disease cannot be proven by clinical trials with divergent outcomes."
10/01/2022 - "Aducanumab Is Not Effective for Mild Cognitive Impairment or Mild Alzheimer Dementia and Has Major Safety Issues."
08/01/2022 - "Objective To review the data informing the US Food and Drug Administration (FDA) approval for aducanumab for mild cognitive impairment (MCI) and mild Alzheimer's disease (AD). "

01/01/2022 - "The patient progressed to moderate dementia (MMSE = 14/30), beyond the targeted early AD treatment stage, before receiving aducanumab in the long-term extension (LTE). "
01/01/2022 - "On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. "
12/01/2021 - "Instead of wasting money on aducanumab, pay for programs proven to help people living with dementia."
12/01/2021 - "Per patient over a lifetime horizon, aducanumab treatment corresponded to 0.65 incremental patient quality-adjusted life-years (QALYs) and 0.09 fewer caregiver QALYs lost compared with patients treated with SOC. Aducanumab treatment translated to a lower lifetime probability of transitioning to AD dementia, a lower lifetime probability of transitioning to institutionalization (25.2% vs. 29.4%), delays in the median time to transition to AD dementia (7.50 vs. 4.92 years from MCI to moderate AD dementia or worse), and an incremental median time in the community of 1.32 years compared with SOC. The model predicted long-term benefits of aducanumab treatment in patients with MCI due to AD and mild AD dementia and their caregivers. "
11/01/2022 - "We apply Bayesian analysis of model plausibility and effect sizes based on simulated data of the two phase 3 trials of aducanumab in prodromal and mild dementia stages of Alzheimer's disease (AD). "

12/01/2021 - "Aducanumab: 4 in 10 high dose trial participants experienced brain swelling or bleeding."
01/01/2021 - "Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. "
01/01/2022 - "In addition, one fatality related to ARIA-E (edema) with aducanumab and one fatality due to ARIA-H (hemorrhage) with donanemab are reported to date. "