Alzheimer's Clinical Trials Consortium (ACTC)

SUMMARY. This is a multi-PI application renewing the U24 Cooperative Agreement to sustain and expand the NIA’s state-of-the-art Alzheimer Clinical Trial Consortium (ACTC) responsible for conducting academic clinical trials across the continuum of Alzheimer’s disease (AD). This ACTC will continue to leverage the depth and breadth of AD clinical research teams at USC, Harvard, and the Mayo Clinic, as well as the considerable experience of investigators at 35 expert AD trial sites. We aim to sustain the optimized infrastructure that efficiently develops and conducts high quality NIH supported clinical trials in AD and related dementias, while addressing the need for Justice, Equity, Diversity, and Inclusion (JEDI) by incorporating JEDI principles across all consortium infrastructure, activities, and studies. Building on our first five years of experience, we will utilize streamlined contracting processes, a centralized IRB with a specific focus on neurodegenerative diseases, and incorporate state-of-the-art informatics and statistical analyses. We will effectively manage performance of clinical trial sites, while identifying, mentoring and supporting new trial sites to improve access to clinical trials. We will foster continued innovation in AD trial design, providing expertise on novel cognitive, imaging, and biomarker outcomes to support future ACTC trial applications. We will evaluate promising exploratory measures imbedded in our current trials, such as Tau PET imaging and computerized cognitive testing, and work to incorporate these measures into a robust platform for future Proof of Concept (POC) trials to rapidly assess signals of efficacy. The ACTC Coordinating Center will leverage the highly experienced teams in Clinical Operations, Data Systems and Management, and Biostatistics at USC. The MRI Unit, led by Mayo, and PET Unit, led by Harvard and UC Berkeley, will capitalize on unparalleled experience with multi-site protocols through ADNI, the A4 Study, and multiple ongoing clinical trials. The Clinical Outcome Instrument and Biomarkers Units will leverage world-class expertise from Mayo, Harvard, and USC to incorporate both standard and novel outcome measures in future trial designs. The new IDEA-CT Unit will provide training and leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and catalyze the next generation of AD clinical trials. The experts comprising this infrastructure provide the highest levels of expertise to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, while also supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. A program facilitating the longitudinal follow up of clinical trial participants with site assistance for brain donation, centralizing tissue banking and sharing is another key aim of the renewal.