New Study Shows Florbetapir F 18 Injection Scans Led to Change in Diagnosis and Management of Patients Being Evaluated for Cognitive Decline
Eli Lilly and Avid Radiopharmaceuticals a wholly owned subsidiary of Lilly, have announced new data showing that knowledge of amyloid status as determined by Florbetapir F 18 Injection imaging altered diagnosis and management in the majority of patients being studied. This is the first study to look at the impact of amyloid imaging on diagnosis and actual patient management using a randomized, controlled prospective design. These findings were presented at the Alzheimer's Association International Conference 2015 (AAIC) in Washington, DC.
The presence of beta-amyloid neuritic plaque in the brain may provide additional information to supplement a physician's clinical assessment of a patient with cognitive impairment. However, a negative beta-amyloid imaging scan indicates sparse to no plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's disease and reduces the likelihood that a patient's cognitive impairment is due to the disease. It is important to note that errors may occur during image interpretation. Also, a positive scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorders and a negative scan does not preclude the development of brain amyloid in the future.
"These study results are the first to suggest in a controlled study that adding florbetapir to the diagnostic evaluation changed actual patient diagnosis and management by physicians who regularly manage this complicated and devastating disease," said Michael Pontecorvo, vice president, clinical development, Avid Radiopharmaceuticals. "Alzheimer's disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. These findings provide further support for how knowledge of the presence or absence of amyloid pathology may affect both diagnosis and management in patients being evaluated for Alzheimer's disease or other possible causes of cognitive decline."
In addition to altering patient diagnosis, results showed that knowledge of amyloid status as determined by florbetapir imaging changed patient management in the majority of study patients, particularly Alzheimer's disease medications (cholinesterase inhibitor use), in a direction consistent with amyloid status. The researchers found no group differences in cognitive performance or health outcomes at one year, and changes in medical history, psychotropic drug use, and psychiatric-related events were not significantly different between the immediate and delayed feedback groups. There was no evidence of increased safety risk associated with early disclosure of amyloid status.
These data add to a growing body of work that suggests knowledge of amyloid status may change intended and actual patient management.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance