The FDA recently approved Leqembi, a new drug by Eisai that has been shown in clinical studies to slow the cognitive decline associated with Alzheimer’s Disease. This approval marks a major milestone in the fight against dementia, as Leqembi is the first drug ever to be approved for Alzheimer’s Disease that specifically targets cognitive decline, offering new hope to patients and their loved ones. But that’s not the only new development in the fight against Alzheimer’s. In addition to Leqembi, the FDA has also registered Speech Vitals, speech analytics technology from Aural Analytics. Speech Vitals is a clinical grade speech analysis product that can help detect changes in cognition early and reduce the cost and time associated with Alzheimer’s Disease diagnosis. In this article, we’ll explore the benefits of both Leqembi and Speech Vitals, and how they can work together to improve clinical outcomes of Alzheimer’s Disease treatment.
FDA approves Leqembi drug, shown to slow Alzheimer’s cognitive decline
The FDA recently approved Leqembi, the first drug ever to specifically target the cognitive decline associated with Alzheimer’s Disease. The drug, Lecanemab, which will be sold under the name Leqembi, is a monoclonal antibody infusion given every two weeks. The drug works by targeting and binding to the amyloid beta plaque protein in the brain. By binding to this plaque, the drug aids the body in destroying these proteins. Patients with Alzheimer’s have high levels of amyloid beta in the brain and Leqembi showed it can lower those amounts and thus help slow the progression of cognitive decline.
Leqembi works differently from other Alzheimer’s treatments, which typically focus on managing symptoms such as memory loss and confusion. Instead, Leqembi is designed to slow the progression of cognitive decline.
What are the benefits of Leqembi?
Over the course of an 18-month clinical trial, Leqembi slowed progression of the disease by 3-5 months. The trial was only conducted on patients with mild cognitive impairment and the study was only short-term. Time will reveal the impact on later stage disease and longer-term applications. The significant benefit of Leqembi is associated with quality of life. Alzheimer’s Disease is devastating and deadly. By slowing progress of the disease, not only may patients end up living longer, but there is great potential for their time to be higher quality with slowed or reduced cognitive impairment. This may allow patients to participate in activities they enjoy and have more meaningful interactions despite their diagnosis.
What are the side effects of Leqembi?
The benefits of Leqembi also come with some hefty side effects to weigh against potential effectiveness. Mild to moderate brain swelling was experienced by 13 percent of participants. Another 17 percent experienced brain bleeding and 3 participants died from brain hemorrhage. The prescribing information also includes a warning of amyloid-related imaging abnormalities (ARIA), risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure, as well as headaches.
Is Leqembi a dementia cure?
Leqembi is not a cure for Alzheimer’s Disease and related dementias. While it can help slow the progression of cognitive decline associated with the disease, it cannot reverse the damage that has already been done. This means that those taking Leqembi will still experience some level of cognitive decline. It is important to note, however, that Leqembi can still be an effective tool in the fight against Alzheimer’s Disease. There are risks associated with the drug that patients and their loved ones must be aware of before starting treatment.
What is speech analytics?
Speech analytics is a type of clinical grade speech analysis effective in the early diagnosis of Alzheimer’s Disease. Speech analytics sensitively measures changes in speech patterns, which can be used to diagnose and measure disease. By using a combination of natural language processing, artificial intelligence, and machine learning to analyze speech changes over time, speech analysis can identify changes that are associated with Alzheimer’s Disease.
Aural Analytics is the industry’s leading speech neuroscience company harnessing the clinical utility of the world’s speech around the globe. Their suite of applications and embeddable SDKs and APIs are available in 25 languages across Android, iOS, and the web and are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological health of its users.
Aural Analytics’s Speech Vitals Cognition product specifically measures changes in cognitive function through a set of tasks available in a free and easy-to-use app. Vast and deep experience in cognition, has allowed the company to develop and validate sensitive metrics that tap speech as a biomarker of cognitive function.
In October 2022, the US Food and Drug Administration (FDA) registered Aural Analytics’s clinical-grade speech analytics product, Speech Vitals, as a computerized cognitive assessment aid, a class II software medical device (SaMD). FDA registration strengthens Speech Vitals’ objective, reliable, generalizable, and repeatable approach to speech analytics, made possible by its clinically and analytically validated measures of speech.
Clinical benefits of speech analytics
Speech analytics are highly sensitive, objective, and repeatable and can identify changes in speech that are associated with Alzheimer’s Disease quickly, easily, and non-invasively. Additionally, speech provides a number of benefits as a digital biomarker:
- Speech is easy to collect on any device remotely or in-clinic and only requires a few minutes
- Speech tracks objectively decline with high sensitivity, longitudinally, and cross-sectionally, allowing for precise and efficient outcome measurements
- Low patient burden and high value generation with more detail per data capture compared to other digital biomarkers
- Speech provides a sensitive and repeatable objective signal that is complementary to other sensors, wearables, and clinical measures
In addition, speech analytics can also help identify changes in speech that are associated with other diseases and conditions, such as ALS and Parkinson’s Disease. This can help doctors diagnose these diseases early, which can help reduce the cost and time associated with diagnosis.
How can Aural Analytics’s clinical grade speech analytics help reduce Alzheimer’s diagnosis cost?
Approximately 6 million Americans live with Alzheimer’s Disease. Of those, it is estimated that around 1 million have an early stage of the disease, though many go undiagnosed. Diagnosis is expensive and difficult in the early stage of the disease, but catching it early can improve outcomes. By identifying subtle changes in speech early on, Aural Analytics’ clinical grade speech analytics, Speech Vitals, can help reliably diagnose Alzheimer’s Disease, even differentiating between mild cognitive impairment and early onset of Alzheimer’s. Compared to the current expensive and time consuming testing required for diagnosis, Speech Vitals can provide both a cost and time reduction associated with diagnosis. Time is everything in the fight against Alzheimer’s. Early diagnosis allows for early intervention, allowing patients to access treatments like Leqembi sooner. This can help reduce the burden on the healthcare system, as well as improve the quality of life for those with Alzheimer’s Disease.
Leqembi is only appropriate for patients with mild cognitive impairment or the mild dementia stage of disease. Patients in a later stage of the disease or patients with non-Alzheimer’s dementia may not be a good fit. Considering the risks and costs associated with Leqembi, ensuring the most advanced and accurate screening to get the right patients in the right treatment at the right time will be critical. Aural Analytics’s Speech Vitals Cognition is a potential solution for healthcare providers and study teams to ensure they are suggesting Leqembi to the right patients.
By combining Leqembi with speech analytics, it is possible to reduce the cost and improve the timeliness of diagnosis of Alzheimer’s Disease and related dementias. If you are interested in learning more about how clinical grade speech analytics can reduce the cost and improve the timeliness of diagnosis of Alzheimer’s Disease and related dementias, reach out to Aural Analytics at info@auralanalytics.com.
Sources
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. FDA. Jan. 6, 2023, accessed Jan. 10, 2023.
Howard Gleckman, The FDA Approved The New Anti-Alzheimer’s Drug Leqembi. What You Need To Know. Forbes. Jan. 9, 2023, accessed Jan. 10, 2023.
