Patients with Alzheimer?s disease and related dementias (ADRD) are at high risk for both developing epilepsy and complications associated with its diagnoses and treatments. Of the 5.4 million Americans with Alzheimer's, nearly 10% also have epilepsy. Epilepsy is an incurable, life-threatening neurological disorder characterized by recurrent, spontaneous seizures, which requires anti-seizure drugs that have serious side effects. Inadequate treatment or inadequate adherence to treatment increases the risk of seizures, disability, and early death. Twenty-two anti-seizure drugs are available in the US but the management of epilepsy in the older age group can be complicated by many factors (e.g., development or progression of memory impairment, drug interactions, adverse events). Ideally, treatments should reduce seizure recurrence with minimal treatment complications. There is currently a dearth of information to guide initial treatment among the elderly. This proposed scientific program aims to examine the impact of available treatments for older patients with epilepsy, with a special focus on patients who have co-morbid ADRD. The principal investigator (PI) has three specific research aims: (1) to examine patient adherence to treatment and safety monitoring regimens; (2) to analyze the impact of anti-seizure drugs on seizure recurrence and treatment specific side-effects; and (3) to determine the impact of anti-seizure drugs on clinical event rates such hospitalization or nursing home placement. The PI will use Medicare claims (2006-13) to assess the anti-seizure drugs available to treat new- onset epilepsy, and exploit recent changes in prescription patterns to examine several outcomes. In particular, the PI will compare treatment choices and outcomes among beneficiaries with and without ADRD. The PI proposes a career development program that includes methodological training and mentorship. The PI will utilize advanced statistical modeling to address the challenges posed by comparative effectiveness research applied to epilepsy care under the guidance of experienced clinician-scientists (e.g., Dr. Bradley Hyman), biostatisticians, epidemiologists, and health policy scientists. Career development activities will include training in management and analysis of large datasets, pharmacoepidemiology, causal inference and comparative- effectiveness analysis. These activities will help prepare the PI to develop a pragmatic clinical trial on the initial treatment of new-onset epilepsy in the older patients during the award period. The PI will also take courses in order to effectively translate research findings into improved clinical practice. The long-term goal of this career development award is to develop the candidate into an independent investigator with expertise in clinical and population research and develop the necessary skills needed to conduct high impact research projects for geriatric patients with chronic neurological conditions. This career development award has the potential to fill the unmet public health need for evidence of safe, effective, and person-centered treatments for geriatric neurology patients.
/Public Health Relevance: Elderly patients in the United States are at high risk for a number of serious medical conditions, including Alzheimer?s disease and epilepsy, who often receive powerful treatments such as anticonvulsant drugs, which unfortunately also have serious side effects. There is insufficient information available today to guide physicians when making decisions about the use of these drugs, or to guide physicians, patients, and caregivers with respect to the potential complications associated with use of these drugs. This study will be the first to examine these issues in a national sample of Medicare beneficiaries, and will help guide policy makers, clinicians, patients, and other stakeholders in an effort to improve the care for our elderly patients.