Eli Lilly and Company, a global healthcare leader, and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced financial commitment and continued scientific partnership to support the recently established Imaging Dementia - Evidence for Amyloid Scanning (IDEAS) study.
The IDEAS study will assess the clinical usefulness and value in using an amyloid brain positron emission tomography (PET) scan in certain situations when evaluating Alzheimer's disease (AD) and other dementias. Amyvid (Florbetapir F-18 injection), Lilly's FDA-approved radioactive PET diagnostic agent for the estimation of beta-amyloid neuritic plaque density in the brain, will be one diagnostic agent available for use in the study. It is important to note that a positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.
Manufactured in and distributed from 30 radiopharmacy facilities throughout the United States, Amyvid is currently supplied to a robust network of PET imaging sites by Siemens' PETNET Solutions and Cardinal Health. Amyvid for intravenous use is supplied in 10 ml, 30 ml, or 50 ml multidose vials containing 500-1900 MBq/ml Florbetapir F-18.
"Lilly is pleased to support and participate in this important study," said David Ricks, Lilly senior vice president and president of Lilly Bio-Medicines. "Alzheimer's disease is one of the most devastating diseases of our time, and we are committed to ensuring that patients and physicians have appropriate and reliable access to this adjunctive diagnostic tool."
Mark Mintun, MD, president of Avid Radiopharmaceuticals represents Lilly on the IDEAS Study Steering Committee. "We hope this study will add important new data to a growing body of evidence demonstrating the value beta-amyloid imaging may bring to patients with cognitive impairment being evaluated for Alzheimer's disease and other causes of cognitive decline," explained Mintun.
The IDEAS Study is led by the Alzheimer's Association and managed by the American College of Radiology (ACR) and the American College of Radiology Imaging Network (ACRIN). Funding and support for the study is provided by the Alzheimer's Association, the Centers for Medicare & Medicaid Services (CMS), and a consortium of industry stakeholders. A total of 18,488 Medicare beneficiaries aged 65 years and older meeting specific Appropriate Use Criteria (AUC) will be enrolled over 24 months at sites throughout the United States as part of the CMS Coverage with Evidence Development (CED) programme.
The IDEAS study will establish an open-label, longitudinal cohort study to assess whether the impact of amyloid PET on patient management results in improvements in health outcomes. Specifically, the study will determine the clinical usefulness and value in using an amyloid brain PET scan in certain situations when evaluating Alzheimer's and other dementias. In diagnostically uncertain cases, knowledge of amyloid status may lead to changes in patient management, such as earlier counseling and prescription of appropriate drugs, which may translate into improved long-term outcomes. The study hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the underlying cause of cognitive impairment, that this will translate into earlier counseling and interventions in these domains, and that these interventions will lead to improved health outcomes.
Imaging sites certified in brain PET and dementia specialists meeting certain ACR-defined criteria will be able to apply to participate in the study on the IDEAS Study website (www.IDEAS-Study.org). Through the online application process, ACR will assess imaging site and dementia specialist eligibility and ultimately decide which sites can join the study. Specific study inquiries or expressions of interest in participation should be directed to ACR via the IDEAS study-dedicated email address (IDEAS-Study@acr.org).
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. It is the most common form of dementia, accounting for 60 to 80 per cent of dementia cases. There are currently an estimated 46.8 million people living with dementia worldwide. The number of people affected by dementia is expected to be nearly 74 million in 2030 and 131 million in 2050.3 Estimates vary, but experts suggest that as many as 5.3 million Americans may have Alzheimer's disease.
Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.