June 27, 2023

Update: FDA Approves Rexulti to Treat Agitation Associated with Alzheimer’s Disease

The FDA approved the use of Brexpiprazole (Rexulti) to treat agitation associated with Alzheimer’s disease following the recommendation of the FDA advisory committees. This is the first treatment approved by the FDA to treat agitation associated with Alzheimer’s disease.

Agitation associated with Alzheimer’s is a common problem, related to feelings of restlessness and worry that can be brought on by stress, lack of sleep, sudden changes, medications and more. The drug makers Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) report that about half of people with Alzheimer’s experience agitation due to the disease and this symptom is a major source of frustration and stress for their caregivers. The companies also state agitation is associated with a higher incidence of being placed in a nursing home.

Data shows that patients who took Rexulti experienced a 31% greater reduction vs. placebo and can help address symptoms of agitation due to Alzheimer’s including behaviors such as pacing, gesturing, profanity, shouting, shoving and hitting.

DISCERN™ Test – Supporting Physicians to Confidently Diagnose Alzheimer’s Disease

The DISCERN test, the first autopsy-validated, highly accurate and minimally invasive test available to support a clinician’s definitive diagnosis of Alzheimer’s disease, provides primary care physicians (PCPs), neurologists, geriatricians and memory care clinic staff with a way to identify the right patients for drugs like Rexulti.

With 50-70% of symptomatic patients misdiagnosed in the generalist setting and 25-30% misdiagnosed in specialty memory clinics, diagnostic accuracy is still a great unmet medical need. With FDA approvals rolling out for Rexulti and other drugs, physicians need time- and cost-effective tools to confidently diagnose patients with Alzheimer’s.

In a study of 402 primary care physicians, clinicians were five times more likely to diagnose Alzheimer’s disease and three times as likely to prescribe disease-modifying drugs for Alzheimer’s with a positive DISCERN test.

The implications of the test are significant, giving patients and families the ability to determine if symptoms truly are from Alzheimer’s disease versus other, possibly curable conditions, giving individuals an opportunity to get the right treatment plan sooner—while giving families greater peace of mind.

DISCERN – A Better Approach to an Earlier and More Accurate Diagnosis

Unlike other diagnostic tests for Alzheimer’s disease, DISCERN is autopsy-validated to identify Alzheimer’s in people recently diagnosed with dementia. No other diagnostic tests have undergone this rigorous autopsy validation for early dementia and no autopsy-validated tests are available to accurately diagnose mild cognitive impairment (MCI) due to Alzheimer’s disease.

DISCERN is designed to inform the presence of AD in people recently diagnosed with dementia, even when they have mixed dementia. The DISCERN test assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with Alzheimer’s disease as well as regulators of amyloid plaque and tau formation, hallmarks of Alzheimer’s at autopsy.

Contact SYNAPS Dx for more information on testing for AD.

* The DISCERN™ test was developed and its performance characteristics determined by NeuroDiagnostics Inc, dba Synaps Dx. It has not been cleared or approved by the U.S. Food and Drug Administration. NeuroDiagnostics, Inc. is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as an accredited laboratory to perform high complexity clinical testing. The test is intended for patients with dementia. Test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician. All rights reserved.