MIREVO Japan’s 1st Neuropsychological Test for Dementia Treatment Now Available
Otsuka Pharmaceutical and Ai-BrainScience Inc. have announced the launch of MIREVO®, a pioneering neuropsychological testing program designed to support medical treatment for dementia. As of January 1, 2025, MIREVO® has become the first Software as a Medical Device (SaMD) in the dementia field to receive national health insurance coverage in Japan, marking a significant milestone in the early detection and treatment of dementia. The marketing of this groundbreaking product in Japan officially began today Neuropsychological.
Dementia is a growing concern worldwide, with increasing prevalence as populations age. Early detection of dementia plays a crucial role in slowing its progression and providing timely treatment to improve the quality of life for patients. The need for efficient, accurate, and easily accessible diagnostic tools has led to the development of new technologies aimed at identifying cognitive decline in its early stages. MIREVO® is one such innovation, utilizing cutting-edge eye-tracking technology to offer a quick, objective, and reliable neuropsychological test for dementia.
MIREVO® is an easy-to-use program that can be administered using a tablet device, allowing clinicians to conduct neuropsychological tests in just a few minutes. The test requires the subject to focus on specific areas of the screen in response to various questions. The results of the test are then automatically scored, providing a quantitative and objective evaluation of cognitive function. This automated process eliminates the potential for variability due to the examiner’s personal knowledge or experience, ensuring more consistent and reliable results.
The MIREVO® test uses advanced eye-tracking technology to monitor the subject’s gaze patterns during the test. Eye tracking is an effective method for assessing cognitive function, as changes in eye movement and attention can indicate subtle shifts in cognitive abilities. The system’s ability to track these changes in real time enables it to provide precise measurements that are indicative of cognitive health, offering a more nuanced approach to evaluating dementia-related cognitive decline compared to traditional methods.
In a clinical study conducted on a diverse group of subjects, including individuals diagnosed with dementia, those with suspected mild cognitive impairment (MCI), and cognitively normal subjects, MIREVO® demonstrated strong results. The primary endpoint of the study was to evaluate the correlation between the MIREVO® test scores and the Mini Mental State Examination (MMSE), which is a widely used tool for assessing cognitive function. The study found that MIREVO® test scores were strongly correlated with MMSE results, validating its potential as an effective diagnostic tool for dementia.
In addition to demonstrating its diagnostic accuracy, MIREVO® was also found to reduce the burden on examiners compared to the MMSE. The secondary endpoint of the clinical study focused on assessing the examiner’s workload, and the results confirmed that MIREVO® significantly reduced the time and effort required by examiners to administer the test. This reduction in examiner burden is particularly valuable in clinical settings, as it allows healthcare providers to test more patients in less time, improving overall efficiency.
MIREVO® represents a significant step forward in the field of dementia diagnosis and treatment. By integrating innovative eye-tracking technology into the neuropsychological testing process, MIREVO® offers a more objective, automated approach to detecting cognitive decline. The program is expected to enhance the early detection of dementia, a key factor in improving patient outcomes and enabling timely intervention.
With its approval as the first SaMD for dementia in Japan and the inclusion of national health insurance coverage, MIREVO® is set to become an integral part of the dementia care landscape in the country. The product’s availability will expand the options for clinicians and patients alike, providing a powerful tool for identifying dementia in its early stages and facilitating prompt treatment.
The launch of MIREVO® is part of Otsuka Pharmaceutical’s broader strategy to diversify its business and expand into the field of diagnostic services. In addition to its long-standing focus on the development of pharmaceuticals, Otsuka is increasingly committed to providing comprehensive healthcare solutions that address the complex challenges posed by conditions such as dementia. By developing diagnostic technologies alongside its therapeutic products, Otsuka aims to offer holistic, integrated solutions that better meet the needs of patients and healthcare providers.
Otsuka’s efforts to provide comprehensive treatment options for dementia reflect the company’s vision of becoming a total healthcare provider. As part of this strategy, Otsuka is continuously exploring new ways to leverage technology and innovation to improve healthcare outcomes. The introduction of MIREVO® exemplifies this commitment and represents a significant advancement in dementia care.
The use of real-time, automated testing methods like MIREVO® is expected to play a critical role in the ongoing battle against dementia. The program’s ease of use, quick test time, and ability to produce objective, accurate results make it an invaluable tool in identifying cognitive decline early. Early detection allows for more effective intervention, improving the chances of better patient outcomes and enhancing the overall quality of life for individuals living with dementia.
MIREVO® also reflects broader trends in the medical field toward the adoption of digital health technologies. With the rapid advancement of software-based diagnostic tools, MIREVO® stands as a testament to the potential of these technologies to transform healthcare. As more health professionals and patients become familiar with digital testing tools, programs like MIREVO® will likely play an increasingly prominent role in the diagnosis and management of dementia and other cognitive disorders.
The approval of MIREVO® as the first SaMD for dementia in Japan is a significant achievement, not only for Otsuka and Ai-BrainScience but also for the broader healthcare community. It marks a pivotal moment in the ongoing efforts to improve the diagnosis and treatment of dementia, a condition that impacts millions of people worldwide. By offering a quick, efficient, and objective method for assessing cognitive function, MIREVO® has the potential to revolutionize dementia care and improve the lives of patients and their families.
As the population of elderly individuals continues to grow globally, the importance of early detection and intervention for dementia becomes increasingly evident. MIREVO®’s role in facilitating early diagnosis through its innovative eye-tracking technology is a critical step toward addressing the growing demand for effective dementia care. Its approval in Japan sets the stage for similar advancements in other countries, paving the way for the development and adoption of new diagnostic tools that will play a crucial role in managing dementia and other neurodegenerative diseases.
In conclusion, MIREVO® represents a breakthrough in dementia care, offering a novel and efficient way to diagnose cognitive decline early. With its approval as the first SaMD in Japan to receive national health insurance coverage, MIREVO® is poised to make a significant impact on the way dementia is diagnosed and treated. Otsuka Pharmaceutical’s commitment to expanding its diagnostic capabilities, alongside its pharmaceutical offerings, reflects the company’s dedication to improving the overall healthcare experience and addressing the challenges posed by dementia. Through innovations like MIREVO®, Otsuka continues to lead the way in transforming healthcare for patients worldwide.
