As the largest resource of information specific to women's brain health, we are sure you will find what you are looking for, and promise that you will discover new information.
Published on: April 7, 2012
by Justine Cadet for Health Imaging
The FDA has approved Amyvid, a radioactive diagnostic agent from Eli Lilly and Avid Radiopharmaceuticals that is indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
Amyvid is a radioactive diagnostic agent tagged with a radioisotope called fluorine-18. Amyvid binds to amyloid plaques, a characteristic of Alzheimer’s disease, and is detected using PET scan images of the brain, according to a Lilly statement.
A negative Amyvid scan indicates sparse to no amyloid 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 Alzheimer’s.
Conversely, a positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer’s disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.
However, the Indianapolis-based Lilly said that a positive Amyvid scan does not establish a diagnosis of Alzheimer’s disease or other cognitive disorders. In addition, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.
Amyvid was evaluated in three clinical studies that examined images from healthy adult patients as well as patients with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program.
Because Amyvid loses over half of its radioactivity every two hours, Amyvid must be distributed directly from a radiopharmacy to the imaging centers where it will be administered within several hours, said the company. Beginning in June, a limited number of radiopharmacies will be distributing Amyvid with the goal of making the product available in more areas as soon as possible.
Amyvid images should be interpreted only by readers who have successfully completed Amyvid reader training, Lilly said. The company added that it has worked with the FDA and nuclear medicine experts to identify the appropriate ways to support accurate and consistent interpretation of Amyvid scans by imaging physicians. These efforts resulted in the development and validation by Lilly of both an online and in-person reader training program for physicians using Amyvid. However, according to Lilly, errors may occur in the estimation of plaque density during image interpretation.
The most common adverse reactions reported in clinical trials were headache (1.8 percent), musculoskeletal pain (0.8 percent), fatigue (0.6 percent), nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent), blood pressure increased (0.4 percent), claustrophobia (0.4 percent), feeling cold (0.4 percent), insomnia (0.4 percent) and neck pain (0.4 percent).
Also, the pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.
A new study led by researchers at Washington University School of Medicine in St. Louis suggests that measures of amyloid beta in the blood have the potential to help identify people with altered levels of...
It’s no secret that if you want to keep your mind sharp, it’s worth making some time to workout. Yes, exercise won’t only give you a sexy body. It’ll help get you a sexy brain as well....
Depression is a constant sadness affecting our activity level, behavior, thoughts, feelings, and sense of well-being. Those affected often feel empty and worthless, which could lead to erratic behavior or even suicide. There are numerous...
The material presented through the Think Tank feature on this website is in no way intended to replace professional medical care or attention by a qualified practitioner. WBHI strongly advises all questioners and viewers using this feature with health problems to consult a qualified physician, especially before starting any treatment. The materials provided on this website cannot and should not be used as a basis for diagnosis or choice of treatment. The materials are not exhaustive and cannot always respect all the most recent research in all areas of medicine.