The $100 million IDEAS (Imaging Dementia — Evidence for Amyloid Scanning) Study is working closely with researchers and government officials to add three additional studies to the main project, where more than 18,000 people with cognitive deterioration but whose diagnosis is unclear are receiving a brain amyloid PET scan.
Those included in the IDEAS Study can take part in one or more of the three new add-on studies. They are:
The Amyloid Neuroimaging and Genetics Initiative (ANGI) Study will pair the clinical information and brain imaging data from the IDEAS Study with DNA obtained from around 3,000 study participants’ saliva samples. ANGI, funded by the Alzheimer’s Association, presents a unique scientific opportunity for new discoveries relating to brain imaging, clinical information, and genetic findings that can have a major impact on dementia care. More than 20 genes associated with risk for Alzheimer’s have been identified. But how these genes relate to amyloid deposits remains unclear. It is hoped that the research made possible by ANGI will ultimately lead to the development of new therapies that will slow or prevent cognitive impairment and dementia. All participation in the study is done by phone and mail so participants don’t need to leave their homes.
The Brain Health Registry (BHR), funded by the Alzheimer’s Association, is an online registry and database for recruiting, screening, and monitoring the progression of Alzheimer’s disease and other brain disorders. The registry will be used to collect lifestyle, cognitive, and health data from IDEAS participants, which will be paired with the amyloid PET results from the IDEAS Study. People in this study can invite a caregiver or study partner to join. The BHR registry aims to collect information that can be used to better understand brain aging and learn more about safe ways to use the internet for brain health screening, and help speed the discovery of treatments for Alzheimer’s and other brain diseases.
CARE IDEAS (Caregivers’ Reactions and Experience: Imaging Dementia — Evidence for Amyloid Scanning) Study will enhance and complement the core IDEAS study by recruiting and interviewing 3,500 patients and their care partners, such as spouses, children, or other family members supporting the patients as they cope with the diagnosis and treatment process.
Ultimately, interview responses will be linked to PET scan results, clinical reports, and comprehensive Medicare Part A, B, and D claims data about IDEAS patients and their care partners. The purpose of the study, which is funded by the U.S. National Institute on Aging, is to estimate the effect of amyloid PET results on how people with Alzheimer’s and their care partners plan for the future.
The study will also examine the impact of the amyloid PET scan results on the care partner, including burden, depression, and their own healthcare.
“We’re very excited by the creation and linking of these important research initiatives,” James Hendrix, PhD, Alzheimer’s Association director of global science initiatives, said in a news release. ”IDEAS is already a landmark research study, especially for clinicians and imagers. Through these three add-on studies, it now has the potential to become a powerful research tool for the entire Alzheimer’s and dementia research community.”
“Together, the IDEAS Study and the three add-ons have the potential to be the largest, most impactful set of coordinated studies on Alzheimer’s disease and other dementias,” Hendrix added. “There is an enormous investment in the IDEAS Study from the public, private, and philanthropic communities. Through launching the add-on studies, and linking them all together, we’re leveraging the huge IDEAS Study population to answer even more questions about Alzheimer’s disease, other dementias, their genetic origins and impact.”
While these add-on trials are not covered under Medicare, they are free to participants. The Alzheimer’s Association is responsible for contacting potential participants; physicians taking part in the project are not required to help in the recruitment for the add-on studies.
After one year, the IDEAS study enrolled about half of its expected 18,488 enrollees, who are Medicare beneficiaries ages 65 and older, at 824 sites in the U.S. Study participants were recruited into one of two sub-groups: progressive, unexplained mild cognitive impairment (MCI), and dementia of uncertain cause.
This four-year project aims to establish if brain positron emission tomography (PET) scans that detects amyloid plaques, a hallmark of Alzheimer’s, make a change in decision-making in the clinical setting and improve Medicare beneficiary patient outcomes.
The IDEAS Study was developed in response to the 2013 Centers for Medicare & Medicaid Services (CMS) National Coverage Decision on amyloid PET imaging in dementia and neurodegenerative disease.
CMS did not provide coverage for the scans, and questioned the ability of PET amyloid imaging to lead to improved health outcomes, such as avoidance of futile treatment or tests, improving or slowing the decline of quality of life, and survival.
“We are imaging the brains of living people, many of whom have Alzheimer’s disease, to determine whether they have one of the hallmarks of the disease, amyloid plaque, which in turn will aid in our diagnosis. Doctors and families may make different decisions with a more precise diagnosis,” said Gil D. Rabinovici, MD, of UC San Francisco, chair of the IDEAS Study.
“This will be especially important for people with an unclear Alzheimer’s diagnosis. In many cases, ruling out Alzheimer’s can be as valuable as confirming it,” he said.
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