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Comparative Analysis of Aducanumab, Zagotenemab and Pioglitazone as Targeted Treatment Strategies for Alzheimer's Disease.

ABSTRACT: Alzheimer's disease (AD) is the leading cause of dementia that has remained a major medical, sociocultural and economical challenge globally. Previously developed treatments like anticholinesterase inhibitors (AChEIs) and N-methyl-D-aspartate receptor (NMDAR) antagonists only provide short-term symptomatic improvement and do not prevent progression. Repeated setbacks and failures over the past 25 years in AD clinical trials have hindered efforts to develop effective AD treatments. Fortunately, Aducanumab, a specific anti-amyloid β antibody, has shown promising clinical results and was recently approved by the Food and Drug Administration (FDA) through an accelerated approval pathway. This has raised hopes for AD patients; however post-approval trials are necessary to estimate the true scope of its clinical benefits. We have reviewed several AD clinical studies and summarized the experience to date with Aducanumab and two other potential AD drugs including Zagotenemab (an anti-tau antibody) and Pioglitazone (nuclear Peroxisome-Proliferator Activated Receptor γ (PPARγ) agonist). These have shown mixed results so far and the next few years will be critical to elucidate and interpret their broad long-term protective effects. A concerted effort is required to understand and strengthen the translation of pre-clinical findings from these drugs to routine clinical practice.

SUBMITTER: Abyadeh M

PROVIDER: S-EPMC8612603 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAlzheimer's Disease (AD), the most common type of dementia, is a chronic, progressive, and neurodegenerative brain discomfort that causes the be damage to brain cells. Although there is no definitive treatment for AD, various drug treatments are used to reduce and control the symptoms of the disease. Developed for the treatment of mild-stage Alzheimer's patients, Aducanumab is the only drug approved by the Food and Drug Administration (FDA) in the past two decades. However, the cost is very high and, in many countries, Aducanumab has not been approved due to insufficient clinical efficacy and lack of evidence yet. This study aims to analyze the cost-effectiveness of Aducanumab, which was developed for the treatment of mild-stage AD, from the patient's perspective.MethodsIn the study, the Markov model was developed to determine the cost-effectiveness of Aducanumab compared to Standard of Care (SoC) therapy over a 5-year horizon. Cost and effectiveness data were taken from the literature. In the study, the discount rate was determined as 6%. The results were presented as the incremental cost-effectiveness ratio (ICER), which represents the cost per quality-adjusted life years (QALY). The results were retested with a one-way and probabilistic sensitivity analysis (PSA) due to possible uncertainties in the research parameters. The results were presented with the tornado diagram and the scatter plots.ResultsWith the Markov model, the total costs of Aducanumab and SoC treatments over a 5-year horizon were found to be 98.068 $ and 21.292 $, respectively. Aducanumab treatment had an incremental gain of 0.64 QALY and an incremental cost of 76.776 $ compared to the SoC treatment. The ICER value, which shows the additional cost per QALY of Aducanumab, was 119.408 $/QALY. As a result of the study, it was determined that Aducanumab was not cost-effective when compared to SoC treatment. Sensitivity analysis results showed stability against uncertainties. Aducanumab was confirmed not to be cost-effective with its current price and potential clinical benefit.ConclusionThe result of the research is considered important in terms of providing evidence-based information on the cost-effectiveness of Aducanumab in Turkey. However, further, research is needed to evaluate Aducanumab's clinical efficacy and cost-effectiveness.

Project description:IntroductionAlzheimer's disease (AD) is a chronic and progressive neurodegenerative disease that places a substantial burden on patients and caregivers. 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. In the phase 3 clinical trial EMERGE (NCT02484547), aducanumab reduced clinical decline in patients with mild cognitive impairment (MCI) due to AD and mild AD dementia and confirmed amyloid pathology.MethodsWe used a Markov modeling approach to predict the long-term clinical benefits of aducanumab for patients with early AD based on EMERGE efficacy data. In the model, patients could transition between AD severity levels (MCI due to AD; mild, moderate, and severe AD dementia) and care settings (community vs. institution) or transition to death. The intervention was aducanumab added to standard of care (SOC), and the comparator was SOC alone. Data sources for base-case and scenario analyses included EMERGE, published National Alzheimer's Coordinating Center analyses, and other published literature.ResultsPer 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.ConclusionThe model predicted long-term benefits of aducanumab treatment in patients with MCI due to AD and mild AD dementia and their caregivers. The predicted outcomes provide a foundation for healthcare decision-makers and policymakers to understand the potential clinical and socioeconomic value of aducanumab.

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Comparative Analysis of Aducanumab, Zagotenemab and Pioglitazone as Targeted Treatment Strategies for Alzheimer's Disease.

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