The FDA approved Neuraceq for PET imaging of the brain to identify beta-amyloid neuritic plaque in patients with cognitive decline or Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) announced today its approval for Neuraceq, which is indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in cognitively impaired adult patients being evaluated for Alzheimer’s disease or other cognitive decline.
There are over seven million new cases of dementia each year worldwide, with Alzheimer’s disease accounting for 60 percent to 80 percent of all dementia diagnoses. Studies have shown that Alzheimer’s gets incorrectly diagnosed in 10 percent to 30 percent of cases, leaving many patients without appropriate treatment.
The Centers for Medicare and Medicaid Services has stated it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development programs, which aim to assess the impact of beta-amyloid scans on improving patient outcomes or advancing treatment options. Beta-amyloid is the primary indicator of Alzheimer’s.
The FDA approval was based on safety data from 872 patients who participated in global clinical trials, and three studies that examined images from adults with a range of cognitive function. The studies included 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and could be useful in estimating the density of these plaques in life.
Neuraceq is manufactured by Piramal Imaging, a division of Piramal Enterprises, Ltd.
Key Chest CT Parameters for Body Composition May be Prognostic for Patients with Resectable NSCLC
February 11th 2025A high intermuscular adipose index has a 49 percent increased likelihood of being associated with lower overall survival in patients with resectable non-small cell lung cancer (NSCLC), according to new research.
Comparative AI Study Shows Merits of RapidAI LVO Software in Stroke Detection
February 6th 2025The Rapid LVO AI software detected 33 percent more cases of large vessel occlusion (LVO) on computed tomography angiography (CTA) than Viz LVO AI software, according to a new comparative study presented at the International Stroke Conference (ISC).
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
Computed Tomography Study Assesses Model for Predicting Recurrence of Non-Small Cell Lung Cancer
January 31st 2025A predictive model for non-small cell lung cancer (NSCLC) recurrence, based on clinical parameters and CT findings, demonstrated an 85.2 percent AUC and 83.3 percent sensitivity rate, according to external validation testing in a new study.