Piramal Imaging is honoured to announce it will provide funding and support, along with other industry partners, for a major clinical study titled, "Imaging Dementia – Evidence for Amyloid Scanning" (IDEAS). The trial is designed to evaluate the impact of positron emission tomography (PET) scanning of beta-amyloid deposits in the diagnosis of Alzheimer’s disease (AD) and Dementia in a defined patient population.
Piramal Imaging’s FDA-approved diagnostic radiotracer for brain beta-amyloid detection, Neuraceq (florbetaben F18 injection), will be one of three radiotracers used in the study. It is honored to be part of this major initiative and looks forward to the results of the study.
The IDEAS initiative, which is led by the Alzheimer’s Association and managed by the American College of Radiology (ACR) and American College of Radiology Imaging Network (ACRIN), will enroll a total of 18,488 eligible medicare beneficiaries age 65 and older at roughly 200 sites throughout the United States over the next two years. The study will evaluate the impact of brain beta-amyloid PET imaging on a variety of patient outcome measures. The study protocol get approval with requirements by the Centers for Medicare & Medicaid Services (CMS). Participatants will be reimbursed for the PET scans under the CMS Coverage with Evidence Development (CED) policy that requires research study participation as a condition of Medicare payment.
Alzheimer's disease is a neurological disorder in which the death of brain cells causes memory loss and cognitive decline. A neurodegenerative type of dementia, the disease starts mild and gets progressively worse. Alzheimer's disease is typically diagnosed after a person with a cognitive impairment undergoes an extensive clinical examination, which typically includes family and medical history, physical neurological and psychiatric examinations, laboratory tests, and imaging procedures such as computed tomography (CT) or magnetic resonance imaging (MRI) scans.
Like all types of dementia, Alzheimer's is caused by brain cell death . While they cannot be seen or tested in the living brain affected by Alzheimer's disease, postmortem/autopsy will always show tiny inclusions in the nerve tissue, called plaques and tangle. There was no specific test that confirms you have Alzheimer's disease However today many patients with dementia symptoms can be misdiagnosed and a typical patient experiences symptoms for two years and visits an average of two to three doctors before receiving a clinical diagnosis. Today the combination of clinical diagnosis and a beta-amyloid biomarker assessment improves the diagnostic accuracy while the patient is still alive.
Neuraceq™ is indicated 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 Neuraceq™ scan indicates sparse to no amyloid 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 Neuraceq™ 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. Neuraceq™ is an adjunct to other diagnostic evaluations.
Following training, image-reading errors (including false positive or false negative interpretation of Neuraceq images) may still occur. Additional interpretation errors may occur due to image noise, brain atrophy with a thinned cortical ribbon, or image blurs. Administration of Neuraceq, as with other radiopharmaceuticals, results in a low amount of ionizing radiation exposure. Safety precautions should be taken to ensure healthcare providers and patients do not receive unintentional radiation exposure from Neuraceq. The most common side effects observed in clinical trials were injection site reaction and injection site pain.
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