It has been nearly 15 years since the last FDA approval for a new treatment for Alzheimer's Disease and Related Dementias (ADRD). Critical to the mission to improve the available therapies and curb the public health impact of ADRD will be a new generation of ADRD scientists, especially scientists with the unique training and skills necessary to design and perform clinical trials. This training is rarely provided through the traditional course of medical or biostatistical education. As a result, there is a dearth of well-trained ADRD clinical trialists. Moreover, there is very limited diversity among the current group of active ADRD trial investigators. To develop improved therapies for ADRD, multidisciplinary expertise in clinical trials will be necessary, including medical specialists but also expertise in biostatistics, trial design, biomarkers, ethics, and informatics. This proposal requests support to establish a first-of-its-kind training program in the essential elements of ADRD trials. The Institute on Methods and Protocols for the Advancement of Clinical Trials in ADRD (IMPACT-AD) Course will leverage the full infrastructure and expertise of the Alzheimer's Clinical Trials Consortium (ACTC) affiliated faculty. IMPACT-AD will be conducted annually to attract and train the next generation of ADRD clinical trialists, with a particular focus on improving the diversity of ADRD clinical investigators across race/ethnicity, gender, and scientific/professional backgrounds. IMPACT-AD seeks to provide a diverse range of clinicians, scientists and researchers with a modern and robust training in the design and conduct of ADRD clinical trials.
/Relevance to public health statement The NIA/AA for Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (NIA/AA IMPACT-AD) Course is a 4.5-day multidisciplinary clinical trial training course providing focused instruction on the design, conduct and analysis of ADRD clinical trials, ranging from mechanistic studies to large, community-based interventions. Multidisciplinary training that combines traditional clinical trials training with specialized skills in statistics, study recruitment, study organization, neuropsychology, ethics and informatics will accelerate the establishment of a new, diverse and well-trained cadre of investigators to lead the development of therapies for ADRD, a key priority for improving public health.
