February 3, 2023

New Recommendation from FDA Advisory Committee: Using Rexulti to Treat Agitation Associated with Alzheimer’s Disease

FDA advisory committees recently recommended the use of Brexpiprazole (Rexulti) to treat agitation associated with Alzheimer’s disease. Although the FDA is not obligated to follow through with this recommendation, experts report the Administration often follows the committees’ guidance.

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.

Rexulti is currently indicated for use in conjunction with antidepressants to treat major depressive disorder and schizophrenia. Otsuka Pharmaceutical and Lundbeck, the sponsors of the drug, note the safety warning for elderly patients with dementia-related psychosis that taking this antipsychotic drug presents an increased risk of death.

One of the challenges noted by a member of the Peripheral and Central Nervous System Drugs Advisory Committee is there is currently no standard of care for people with Alzheimer’s disease. One of the reasons for this could be that in the past, physicians had no way of diagnosing people with Alzheimer’s before autopsy and were therefore hesitant to provide a definitive diagnosis and form a treatment plan.

Value of DISCERN™ Test

Fortunately, 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 intended to treat symptoms related to Alzheimer’s. With this innovative technology, patients and families can 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.

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

DISCERN Answers the Demands for an Early, Accurate Diagnosis

According to the Alzheimer’s Association, 50-70% of symptomatic patients are misdiagnosed with Alzheimer’s disease in the generalist setting. While this number drops to 25%-30% in specialty memory clinics, diagnostic accuracy is still a great unmet medical need.

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