Though most patient advocates are pleased with the hope of having a new drug to treat AD, the approval of aducanumab creates unnecessary uncertainties for patients, clinicians, and researchers. The European Medicines Agency has recently voted against the approval of aducanumab for use in European countries. In this review, evidence from clinical trials of aducanumab, implications of aducanumab approval, and future directions in the management of patients with Alzheimer’s disease are discussed.
- The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country.
- The development and commercialization of this drug was never approved nor commercially distributed in Canada, and its maker has announced a plan to discontinue distribution in the U.S. in 2024.
- Subgroup analysis after protocol amendment showed similar results as the EMERGE trail [46].
It was not tested in people who had progressed to moderate dementia – a state in which the patients lose the ability to care for and feed themselves. A new drug for treatment of Alzheimer’s disease holds promise, but comes with several caveats. For one thing, it is not a cure, but is aimed aducanumab price in india at slowing down cognitive decline. It is vital to obtain a brain MRI before starting aducanumab, as ARIA may develop with treatment. ARIA-E can be visualized as brain edema or sulcal effusions, and ARIA-H can be observed as microhemorrhage and superficial siderosis on brain imaging.
Economics and cost
The inconsistencies can be linked with fewer numbers of patients in the ENGAGE trial receiving higher doses of aducanumab. Based on this finding, the ENGAGE trial protocol was amended to allow patients with APOE4 gene carriers to receive higher doses. Subgroup analysis after protocol amendment showed similar results as the EMERGE trail [46].
Until recently, all approved treatments for AD were symptomatic and not disease modifying. On 7 June 2021, the US FDA approved aducanumab, a human IgG1 anti-Aβ monoclonal antibody selective for Aβ aggregates, as the first disease-modifying treatment for AD. Aducanumab is approved in the United States for the treatment of mild cognitive impairment or mild-dementia stage of AD. In this Editorial, we review the trial data for aducanumab in the treatment of AD and the controversies that its approval has generated.
What is the Alzheimer Society of Canada’s stance on aducanumab today?
Therefore, vaccines for the elderly might require a potent adjuvant to enhance the immune response [65]. However, vaccines provide cheaper and affordable alternatives to drugs [65, 66]. More importantly, the study found that there was no cognitive decline in 47% of the people who received the drug as compared with 29% of those who received a placebo. Over an 18-month period, the trial met the primary endpoint of slowing cognitive decline in those with early Alzheimer’s.
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Evolving treatments for AD
“There are some hyped medicines and it could be possible that when tried on the ground they may not be useful. Still, we are in a desperate situation and hope the drug is useful,” Dr Deshpande said. This narrative review did not include studies indexed in databases other than Google Scholar, Web of Science, and MEDLINE. Future AD management is likely to focus on passive immunotherapy, vaccines, and early diagnosis based on neuroimaging, CSF, and plasma biomarkers. Schematic representation of aducanumab targets (soluble and insoluble beta-amyloid peptides); source [73]. Some states, such as Massachusetts and Tennessee, have requested waivers and adjustments from CMS to offset this possibility, for now, the responsibility remains at hand.
However, the inconsistent results observed with aducanumab may be explained by the limited brain penetration and lack of selectivity for the soluble Aβ-oligomers, which are implicated as upstream drivers of neurodegeneration by multiple studies [48]. The most common adverse events reported within these two studies were ARIA, headache, diarrhea, and fall. ARIA-E was reported in 34% and 35.5% of patients who received high-dose aducanumab in EMERGE and ENGAGE, respectively. Both trials had patients with an average age of 70 years and included patients with APOE gene carriers and noncarriers. The trial used a clinical dementia rating scale to evaluate the impact of taking the drug in delaying the progression of the disease. The ENGAGE trial and EMERGE trials were terminated before completion due to lack of benefit based on data of the early 1748 patients in March 2019.
The reviewers concluded that there was no convincing evidence from available data that there was a delay in clinical progression of cognitive or functional decline from these studies. They noted that the single positive timepoint was un-replicated and conflicted by the second study. Additionally, the delayed start design with termination for futility did not help with the completeness or interpretability of long-term follow-up data in these studies. Aducanumab at a high dose has the potential to slow down the cognitive decline linked with Alzheimer’s in patients with early-onset disease.
Based on the subject’s body weight per kilogram (kg), aducanumab should be diluted with 100 mL of 0.9% sodium chloride injection before administration as an infusion. It is also recommended the diluted agent solution be settled at room temperature before starting therapy and should be administered without delays. Unused diluted portions after administration of aducanumab should be discarded.
Now, the consecutive success of three therapies in two years in slowing cognitive decline in patients with early Alzheimer’s establishes more firmly the theory that one of the main causes of the disease are the abnormal clumps of amyloid beta protein around brain cells. Donanemab is a monoclonal antibody that targets the abnormal plaques of amyloid beta protein characteristically seen in brain images of those with Alzheimer’s. Its mechanism of action is similar to Lecanemab, the drug developed by Japanese and American companies Eisai and Biogen that received a fast-track approval from the FDA earlier this year.
Before initiating aducanumab, the prescribing clinician should obtain brain imaging by MRI within a 12-months period. The healthcare professional administering aducanumab should carefully follow the titration schedule during the first seven infusions. During infusion administration of aducanumab, the provider should be prepared and equipped in a setting with appropriate management in the event of hypersensitivity-like reactions. https://1investing.in/ Another MRI should be obtained during the seventh infusion (first 10 mg/kg dosage) and the twelfth infusion (sixth 10 mg/kg dosage). A study by Salloway et al. reviewed the clinical and radiographic aspects of ARIA in both EMERGE and ENGAGE trials [49]. The study found that 425 of 1029 individuals (41.3%) developed ARIA during the placebo-controlled trial period, with 14 patients developing significant events (1.4%) [49].
This decision of the FDA has become controversial with experts saying that clinical trials of the drug had returned unsatisfactory. Within a year, a second drug has been found effective in checking cognitive decline in people with early Alzheimer’s. Developed by the pharmaceutical giant Eli Lilly, Donanemab was found to slow down cognitive decline by 35% when compared with a placebo in a phase III trial.