Caring for Patients With Dementia
The Future of Early Diagnosis, Treatment, and Care
There are more than 2,000 dementia candidate drugs in clinical trials in the United States. The lion’s share of public attention goes to clinical trials and subsequent drugs produced by the largest pharmaceuticals and those targeting amyloid beta. These drugs represent the continued pursuit of a biological underpinning of dementia that we now know is likely not the right target.
For more than a decade, these drugs have failed to yield clinical benefit and become publicly available. The most recent news regarding positive early results for yet another candidate drug pursuing this same target leaves many unanswered questions for providers.
How to handle questions from patients and what to do about offering these drugs in the future comes back to informed consent. All clinicians can do is share the data as we know it and help patients make the best decision. The most recent drugs targeting amyloid beta ultimately suffer the same fate for most patients. Namely, they are too expensive, carry significant side effects, including a high chance of amyloid-related imaging abnormalities, cerebral edema, and microhemorrhages, all while offering very modest clinical benefits. Patients in these trials should understand that the significant effect, when present, is a small improvement on primarily subjective questionnaires. Numerical improvement in mostly subjective questionnaires of 5% to 15% may not be enough for clinicians, patients, or their families to notice in the course of a normal day.
Drugs, Dementia, and Data Deluge
For those of us practicing medicine, our commitment to do right by our patients cannot be overpowered by these pressures. We can help our patients understand the various perspectives, educating them and supporting their decisions. We can also continue to support our peers who continue researching new avenues of diagnosis and treatment. These organizations do offer great resources for patients and that is perhaps where the focus should remain for them. Campaigning for the FDA to disregard the science is inappropriate and ultimately harmful to patients. As providers, we are in the toughest position because we must absorb information from pharmaceutical sales representatives and contrast it to peer-reviewed articles. This information helps clinicians guide patients, who, as a result of exposure to so much biased information, may come with strong opinions without understanding the real risks and benefits of treatment. All practitioners must be aware of these risks and benefits and offer informed counsel to our patients. Clinicians can remind patients there are drugs in trials pursuing a wide variety of targets, many of which do hold promise.
Much of the science has led us to look “higher” at dementia’s biochemical pathways. Instead of focusing on the end-result proteins found at the time of tissue damage in the brain, we have learned much about the various steps leading to those changes over the course of many years prior to clinical presentation. Several of the drugs currently in clinical trials provide promise by specifically targeting these pathways earlier in the inflammatory process. One theory is that these drugs are more effective earlier in the course of the disease process, but clinically we do not have a track record of diagnosing patients early. We historically have lacked the tools. Alongside the hundreds of clinical trials now underway in the United States is the research for new diagnostics. Having access to less invasive, cheaper, and more accessible diagnostic tests will open the door for earlier diagnoses and better therapeutics. It’s difficult to run a clinical trial for a drug candidate because recruiting an accurately characterized patient cohort is nearly impractical due to time, cost, and lack of sensitivity and specificity of tests.
If practitioners want to provide patients with a specific diagnosis of Alzheimer’s, they need to have the patients get a lumbar puncture and then go through the logistical challenge of sending a highly sensitive sample of the patients’ cerebrospinal fluid to one of only two labs in the country that process this sample. The test is not covered by most insurances, and the cost is absorbed in the reimbursement for the lumbar puncture procedure itself, so most facilities, understandably, do not want to perform the test. Other than this test, there are other less confident specialized tests available such as fluorodeoxyglucose positron emission tomography scans, but these are only approved for reimbursement by Medicare for very specific scenarios (eg, differentiating Alzheimer’s from frontotemporal dementia). Amyloid imaging is still neither available nor affordable, and even then, it’s not always very helpful as a diagnostic, given the amyloid burden that comes along with normal aging.
There are a number of other peripheral diagnostic biomarkers on the horizon that we can be cautiously optimistic about. We can all agree that a noninvasive peripheral blood test rather than a lumbar puncture or a specialized brain scan is a positive alternative. As these diagnostics become more widely available and used, clinicians will have a much better characterized population and can then work through treatment algorithms.
The lack of diagnostic specificity in the general population is why the primary class of drugs that have dominated the dementia world for the last 25+ years are the acetylcholinesterase inhibitors (AChEIs). It’s been disappointing in recent years to consistently see and hear so much doubt and resistance to prescribing these medications. Given how long these drugs have been around, we have the benefit of extensive research to help guide our decisions. In the case of AChEIs, we can confidently counsel patients that, especially when used in the earliest stages of dementia, these drugs can add years of quality life. Notably, AChEIs do not have an immediate impact, and this may be the reason for the deflated reaction. Instead, they work over the long term, helping to relieve the downward slope of cognitive and functional decline without changing the final outcome or treating the underlying cause. AChEIs give patients a bit more time with what’s left, and their side effects are generally mild.
There is quite a bit we can do with the existing treatment options to standardize and improve care. Simply increasing the rates of diagnosis, even for dementia and severity, without getting more specific than that, along with offering the treatments we have available now, would have a tremendous impact on our patients.
Dementia Diagnosis Is Transitioning to the Primary Care Physician
As practitioners, we need to accept that dementia is no longer a specialist-driven diagnosis. In the vast majority of cases, the primary care provider (PCP) is best positioned to provide a diagnosis. Keep in mind, general neurologists and psychiatrists have little more training than PCPs in diagnosing dementia. Geriatricians are often more comfortable in this space but they are few and far between. It’s not until reaching subspecialty-trained dementia specialists, of which there are even fewer, that there is expertise regarding current guidelines. Dementia specialists, however, are best used for rare or more challenging cases. The majority of people suffering from dementia fall into only a few categories for which the previously mentioned upcoming diagnostics and treatment options prove beneficial.
That’s not to say PCPs deserve any more on their plates. However, with just a few steps that generally fit into the annual wellness visit or otherwise in the course of normal care, clinicians can provide a confident diagnosis of dementia and an accurate staging. PCPs do not need at this time to aim for a specific biological diagnosis but, rather, to establish dementia and its severity. This is vital for patients. Providing clarity and direction to patients and families is invaluable. Routinely patients and families express appreciation and gratitude for the information provided, which they can feel empowered to act on. Referrals in the cases of typical dementia (Alzheimer’s disease, vascular dementia, etc) only delay care and do not necessarily lead to better outcomes. False positives are not common, and the downside to giving someone a diagnosis of dementia that later turns out to be inaccurate is minimal. Patients will have received care that is generally helpful regardless of the diagnosis (eg, physical therapy, occupational therapy, speech therapy, etc) and perhaps exposure to unnecessary medications (such as AChEIs) that are easily stopped. In my experience, this is very uncommon and in the few cases I have reversed a diagnosis, it was after clearly reversible causes of cognitive decline were addressed (eg, treating sleep apnea). Ideally, the diagnosis should not be given unless reversible causes of cognitive decline are addressed first.
Beyond the diagnosis of dementia and staging, clinicians should aim to provide as much specificity to their patients as possible. Again, this step does not prevent intervention from starting. Giving a diagnosis of mild stage Alzheimer’s disease is somewhat more helpful than diagnosing mild stage dementia because it will open the avenues to more targeted treatment. In comparison, a diagnosis of mild stage dementia is vastly more useful for a patient than an unspecified diagnosis of memory loss. Specific diagnoses also fuel research for new treatments and help patients with eligibility once those treatments are available. Even with existing tools, the industry is slowly moving toward more specificity.
Technology-Enabled Cognitive Testing and Care Planning
With computerized testing, patients can be tested in the comfort of their own homes or in the office. Medical assistants or other office staff can administer the tests, which are standardized by design, eliminating the need for provider time. These tests also may qualify for reimbursement using existing and widely accepted CPT codes (eg, 96132). These tests go a long way in reducing the significant wait times for patients to receive neuropsychological testing and reduce the burden on neuropsychologists who are buried in months and sometimes years-long waiting lists. In most cases, patients do not need full neuropsychological testing, but until these tests became available, there was no other option. Neuropsychologists are best utilized for patients suffering from rare or inscrutable presentations.
Once you’ve completed the above steps characterizing a patient’s history and presentation and have arrived at a diagnosis of dementia or mild cognitive impairment, there is still the question of what comes next. Often, it’s hard to know what to do next once a diagnosis is reached, and a care plan is always helpful for patients and their families, as well as for providers, to have as a reference. Technology also helps ease the implementation of care planning and linking patients to resources.
Although we have reimbursement for care planning services, specifically using CPT code 99483, in practice it’s easier said than done. The requirements for this code are generally seen as too onerous to implement. Unfortunately, the intentions of this CPT code have largely gone unrealized. Using digital tools; however, the cognitive care plan can be implemented with a fraction of the effort. Now, the data required from the care partner, the patient, and the provider are quickly and easily obtained and then seamlessly integrated. The impact of a care plan should not be underestimated. Providing clear guidance to patients on lifestyle modifications at this stage is actionable and efficacious in improving function. Reminders for family planning tasks and guidance for placing appropriate referrals and links to community resources are all critical. Patients naturally have a lot of questions following a diagnosis, but the time immediately following the diagnosis is often a blur, and a care plan provides a living document that patients and families can return to at their choosing when the time is right. States and service organizations, such as Washington state, offer outstanding resources that can also be integrated into the care plan. There’s no need to reinvent the wheel.
Hopefully, the pursuit and delivery of an accurate dementia diagnosis is less intimidating at this point. Remember the following key steps:
• Take a thorough history and establish a slow and steady decline. Listen to your gut and use objective evidence.
• Make sure you aren’t missing any dementia imitators such as sleep apnea and other reversible causes such as B12 deficiency, hearing loss, etc.
• Complete cognitive testing and establish overall cognitive impairment as well as any pattern of decline among cognitive domains to help point to a more specific diagnosis.
• Deliver your findings to your patient and family and follow up with a cognitive care plan.
The hope is to demonstrate that technology is making dementia care more accessible, enabling early diagnosis and intervention. We all have a part to play in helping our patients and loved ones find clarity about what is causing cognitive decline and what to do about it.
— Reza Hosseini Ghomi, MD, is a practicing neuropsychiatrist focused on neurodegenerative disorders. In addition to serving as chief medical officer at BrainCheck, he is a cofounder and neuropsychiatrist with Frontier Psychiatry, faculty member of the University of Washington department of neurology and UW Institute for Neuroengineering, and an affiliate at the eScience Institute. Ghomi completed his MD at the University of Massachusetts Medical School, his residency and fellowship training in psychiatry and neurology with a focus on memory and movement disorders at the University of Washington, and his MSE in biomedical and electrical engineering at Johns Hopkins University.