Lilly announces opening of patient enrollment for New IDEAS: Imaging Dementia - Evidence for Amyloid Scanning study
"The timely and accurate use of diagnostic tools can facilitate appropriate patient management, treatment decisions and resource planning, which may enable tailored approaches that ultimately improve health," said
New IDEAS seeks to ensure patients living in under-served communities are included in Alzheimer's disease research. Studies show that in the
"The IDEAS study has provided strong evidence that amyloid PET imaging can be a helpful tool to improve the accuracy of Alzheimer's diagnoses and lead to better patient management, especially in difficult-to-diagnose cases," said
About the New IDEAS Study
The New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study is a coverage with evidence development (CED) Study that will build upon the results from the original IDEAS Study.1 The Study will assess the impact of amyloid PET brain scans on patient management and health outcomes, and will address additional gaps in knowledge that are highly relevant to improve precision in future coverage decisions and implementation of amyloid PET in clinical practice.2
A major limitation of the original IDEAS cohort is lack of racial and ethnic diversity, with 88% of participants identified as non-Hispanic White/Caucasian.1 In addition, patients with typical clinical presentations of Alzheimer's disease were not included in the original IDEAS study, and ApoE genotyping was not performed.1
A total of 7,000 Medicare beneficiaries meeting specific inclusion criteria will be enrolled over 30 months at sites throughout
Amyvid is indicated for the estimation of beta-amyloid neuritic plaque density in the brain.4 It is important to note that a positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.4 Information about Amyvid reader training can be accessed at https://amyvid.myregistrationp.com/amyvid/index.do. Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F-18.4
The study protocol for New IDEAS was approved by CMS in
The New IDEAS Study is directed by the
For additional information, please visit the study website at www.IDEAS-Study.org.
About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer's is the most common form of dementia, accounting for 60 to 80 percent of all cases.3 There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050.7 Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3 seconds, and a significant increase in the caregiving burden placed on society and families. In the
Indication and Important Safety Information for AMYVID
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 and other causes of cognitive decline. A negative AMYVID scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's Disease at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease. 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 Alzheimer's Disease, 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.
Limitations of Use
A positive AMYVID scan does not establish a diagnosis of Alzheimer's Disease or other cognitive disorder. Additionally, 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 for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.
Important Safety Information
Warnings and Precautions
Risk for Image Misinterpretation and other Errors
Errors may occur in the AMYVID estimation of brain neuritic plaque density during image interpretation.
Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of AMYVID images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the AMYVID scan as well as motion artifacts that distort the image.
AMYVID scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
AMYVID, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Most Common Adverse Reactions
The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%).
For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf.
AM HCP ISI 10JAN2014
This press release contains certain forward-looking statements about the IDEAS study and about Amyvid® (Florbetapir F 18 Injection), a radioactive diagnostic agent 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. This release reflects
- New IDEAS. Original IDEAS Study. https://www.ideas-study.org/Original-Study. Accessed
December 8, 2020.
- New IDEAS. About Us. https://www.ideas-study.org/About-Us. Accessed
December 8, 2020. Alzheimer's Association. Facts and Figures. https://www.alz.org/alzheimers-dementia/facts-figures. Accessed December 8, 2020.
- AMYVID (Florbetapir F18 Injection) for intravenous use. Full Prescribing Information.
Eli Lilly and Company. Dec 2019. Available at: https://pi.lilly.com/us/amyvid-uspi.pdf.
- Rabinovici, G., et. al. (2019). Association of Amyloid Positron Emission Tomography With
Subsequent Changein Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia. JAMA, 321(13), 1286–1294.
- Jack, C., Bennett, D., Blennow, K., et al. (2018). NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimer's & Dementia, 14(4), 535-562.
Disease International. World Alzheimer Report 2019. https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf. Accessed December 8, 2020. American Association of Retired Persons(AARP). 2020 Report: Caregiving in the U.S.https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf. Accessed December 8, 2020.
AMYVID® is a registered trademark owned or licensed by
PP-AM-US-0274 12/2020 ©Lilly LLC,
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