Yes, well, there are a number of appropriate use recommendations for things like amyloid PET, cerebrospinal fluid that say these specialized tests should be considered after a comprehensive clinical evaluation is performed. And if you want to go looking for what a comprehensive clinical evaluation is supposed to be, you have to go back to the 2001 American Academy of Neurology guidelines, which was the last time at least in the United States that there were guidelines developed to try to provide recommendations for what a high-quality evaluation should be...
Yes, well, there are a number of appropriate use recommendations for things like amyloid PET, cerebrospinal fluid that say these specialized tests should be considered after a comprehensive clinical evaluation is performed. And if you want to go looking for what a comprehensive clinical evaluation is supposed to be, you have to go back to the 2001 American Academy of Neurology guidelines, which was the last time at least in the United States that there were guidelines developed to try to provide recommendations for what a high-quality evaluation should be. And so that’s quite a long time ago and those were targeted specifically to neurologists. And so we met with leaders at the Alzheimer’s Association and my colleague and I, Ali Atri, who chaired the effort and said, we really want to convene a multidisciplinary group of people representing both specialty care and primary care and develop new guidelines that would be contemporary and that would be applicable not just to specialty care but also to primary care. And really a lot of what they focus on is the shared decision-making that we try to engage in with patients and care partners, the fact that you really need a care partner involved to provide an independent perspective on a patient’s symptoms because patients often don’t have full insight into their symptoms. And that the testing should be done with validated instruments, both measures of people’s symptoms in daily life and measures of people’s performance on cognitive test screening measures, and really interpreted in the context of all of that information, including patients’ risk profiles, including things like family history and age and so forth. And then ultimately leading to a three-step diagnostic formulation. So the goal would be if a person has cognitive impairment or dementia to delineate their cognitive functional status. Do they have mild cognitive impairment, in which case they’re still independent in daily activities even though they may be having symptoms? Or do they have dementia, in which case they’ve lost some independent social or occupational function? And then the second step is what’s their cognitive behavioral syndrome? Do they have a predominantly amnestic syndrome? Do they have aphasia? What are the key features of their illness? And then third, what’s the underlying brain disease or brain diseases or conditions that are causing or contributing to their symptoms? And ultimately, we think that arriving at that three-step diagnostic formulation will give people the best opportunity to then embark on a comprehensive management plan, potentially including the disease-modifying therapies that are newly available for Alzheimer’s disease or clinical trials for the particular illness that they’re living with.
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