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Developing a pathway to support the appropriate, affordable, and widespread use of effective Alzheimer's prevention drugs

Alzheimer’s disease (AD) is themost common form of cognitive impairment in older adults and remains among the greatest global public health challenges. Thedisease accounts for about 70%of persons living with dementia, including 10%of all persons over age 65 and about 33% of those over age 85.1 The overall AD burden possibly expands with the inclusion of nearly 55% of persons with mild cognitive impairment (MCI)2 comprising 15% of all persons over age 65, and more than 25% of those over age 80.3 The burden further increases with the inclusion of the nearly 30% of cognitively unimpaired people persons 65 years and older and the nearly 15% of those age 80 and older, who have a positive amyloid positron emission tomography (PET) scan.4 The global cost due to AD and AD related dementias (ADRD) is estimated to be nearly 1 trillion USD,5 and the inflation-adjusted cost may balloon to nearly 2 trillionUSD by 2030 asmore people live to older ages. Yet, the actual cost of AD/ADRDmay be significantly higher. Although emerging AD-modifying treatments have the potential to help cognitively impaired persons and their family caregivers, these interventions will require changes to health care. Among the most important adaptations will be the manner in how sufficient clinical workforce personnel and health care infrastructure will be available to provide timely and equitable access to diagnosis, treatment, and care. Many in the AD/ADRD field acknowledge these challenges and are working to address specific bottlenecks in thepatient journey.6–9 However, the transformation of established and existing clinical care health systems optimized for quality patient-centered dementia care is not trivial. In the United States alone, there are several significant competing issues to assure reliable, valid, and equitable identification within the context of established health care systems. This challenge ismagnified amongunder-represented, underserved, aswell as vulnerable populations, where disease burden often may be greater, and members of those communities have poorer access to quality health care. However, the rapidly evolving emergence of fluid-based biomarkers for preclinical AD and the potential for additional future AD-modifying interventions may provide innovative strategic options for health care system planners focused on dementia care. AD-modifying treatments now in development could have a more profound benefit if introduced prior to the onset of cognitive impairment. If prescribed correctly, this clinical strategy could greatly enhance quality outcomes for at-risk/elevated-risk persons and health care systemsbyaverting rather thanprolonging thedisease. Treatments that postpone the clinical onset ofADbyonly5yearshave thepotential to reduce the prevalence of AD dementia by nearly half, and prevention therapies may have an even greater potential to lessen dementia burden.10–12,13 Although there are no guarantees in study outcomes, clinical trials in the early clinical stages of AD, along with recently initiated or planned prevention trials in the preclinical stages of AD, increase the possibility of approval of effective AD prevention drug therapies roughly in time to meet part of the 2025 goals of the National Plan to Address Alzheimer’s Disease (NAPA).7 Amyloid plaques and phosphorylated tau–containing neurofibrillary tangle–bearing neurons remain the most proximate and important therapeutic candidates available for clinical trials. Indeed, several amyloid plaque-reducing monoclonal antibody therapies have shown promise to reduce amyloid plaque deposition, to reduce biomarkers of amyloid-mediated tau pathophysiology, and suggest but have not yet definitely shown a clinical benefit in the early clinical stages of AD. Meantime, researchers have begun to develop a more diversified portfolio of investigational treatments, including those that target other elements of AD and the other neurodegenerative and cerebrovascular pathologies with which they are commonly associated, providingmultiple shots on goal. There is another mandate within NAPA: the need to ensure that all ADRD interventions are appropriate, affordable, and accessible. This means equity in health care especially for persons from underrepresented groups, under-privileged communities, and developing countries. Implementation of this policy mandate requires innovation to provide scalable approaches. Specifically, there is a need to: