Major New Research Study to Demonstrate Value of PET Scans In Alzheimer’s Disease Diagnosis
The IDEAS Study will assess the impact of brain amyloid PET imaging on a variety of patient outcomes. The study protocol received approval with requirements by the
IDEAS is led by the
Why the IDEAS Study is Needed
Two abnormal structures called plaques and tangles are prime suspects in damaging and killing nerve cells in Alzheimer's. The plaques are deposits of a protein fragment called amyloid-beta that build up in the spaces between nerve cells. Amyloid PET imaging represents a potential major advance in the clinical assessment of people with cognitive impairment. The technology makes amyloid plaques light up on a brain PET scan, enabling for the first time accurate detection of plaques in living people.
"The purpose of the IDEAS Study is to examine how brain imaging, specifically an amyloid PET scan, helps guide doctors in diagnosing and treating Alzheimer's and other dementias in cases where the cause of cognitive impairment is difficult to diagnose," said
The IDEAS Study was developed in response to the 2013 CMS National Coverage Decision (NCD) on amyloid PET imaging in dementia and neurodegenerative disease (CAG-00431N) not cover the scans because "the evidence is insufficient to conclude that the use of positron emission tomography (PET) amyloid-beta (Aß) imaging is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of …
CMS 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. However, CMS did find sufficient evidence that the use of PET Aß imaging is promising: (1) to exclude Alzheimer's in narrowly defined and clinically difficult diagnoses, and (2) to enrich clinical trials seeking better treatments or prevention strategies for Alzheimer's. Under the NCD,
"I am confident that, at the end of this study, we will have amassed sufficient data to assess whether amyloid imaging has a positive impact on patient outcomes leading to expansion of beneficiary access to this important procedure beyond the IDEAS Study," said
The IDEAS Study in More Detail
Amyloid PET imaging alone does not establish a diagnosis of Alzheimer's disease, but must be considered in the context of the person's medical history, physical examination, and cognitive testing. To guide clinicians on how best to apply amyloid PET in the clinical evaluation of people with cognitive decline, a working group convened by the
The AUC indicate that amyloid PET should only be considered in patients with clear, measurable cognitive deficits when there is substantial diagnostic uncertainty after a comprehensive evaluation by a dementia specialist. According to AUC, amyloid PET may have greatest value in patients with either: (1) progressive, unexplained mild cognitive impairment (MCI); or (2) dementia of uncertain cause due to atypical or mixed symptoms, or unusually early age-of-onset.
A total of 18,488
All referrals to the study and for amyloid PET will come from dementia specialists, defined by the
The IDEAS Study will address two specific aims:
- Assess the impact of amyloid PET on the management of patients meeting Appropriate Use Criteria.
- Assess the impact of amyloid PET over 12 months on major medical outcomes such as hospital admissions and emergency room visits in patients enrolled in the study compared to matched patients not in the study.
Aim 1 investigates the impact of amyloid PET on short-term patient management by comparing pre-PET intended management to post-PET actual management recorded 90 days after the scan by the referring physician. Examples of changes in management include: use of Alzheimer's drug therapy, other drug therapy, and counseling about safety and future planning.
Aim 2 utilizes
"In pursuing these aims, we also will generate valuable data on clinical utility that will inform future use of brain amyloid PET as a diagnostic tool, and establish a large group of patients who have had amyloid PET and can serve as a study population to address future research questions," Rabinovici said.
IDEAS Study Leadership
The IDEAS Study Chair is
The total budget for the study is estimated at
Why An Accurate Alzheimer's Disease Diagnosis Is So Important
Accurately diagnosing the cause of cognitive impairment and dementia helps direct therapy and leads to a care plan that improves patient safety and minimizes the risk of preventable complications. Establishing the diagnosis in the early stages of cognitive impairment enables people to participate in care planning and legal and financial planning, while they are still able, and thus promotes patient autonomy. Studies suggest that most people seeking a cognitive evaluation want to be informed if Alzheimer's is the cause of their symptoms. Receiving a definitive diagnosis often has a positive psychological impact on most people who are experiencing memory and thinking symptoms and their caregivers.
Nonetheless, the
The diagnosis of Alzheimer's and other dementias is currently based on the person's history, physical examination, and cognitive testing. The limitations of this approach are increasingly evident, and have negative implications for patient care. For example, studies suggest that the majority of eligible patients do not receive approved Alzheimer's drugs, which have been shown to improve symptoms in dementia due to Alzheimer's in some people for a period of time. Conversely, research shows that Alzheimer's drugs are regularly used off-label in people with non-Alzheimer's causes of dementia. For these people, use of these medications is often associated with adverse outcomes.
Lack of diagnostic accuracy also represents a barrier to developing and testing drugs. In two recent Phase III trials of immunotherapies targeting amyloid-beta, approximately 20% of patients clinically diagnosed with mild to moderate Alzheimer's did not show evidence of amyloid on PET scans, and thus lacked the primary drug target.
The
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