Deborah Tobias
Deborah Tobias serves as the Administrative Unit Co-Lead for the Alzheimer’s Clinical Trials Consortium (ACTC) and is the Director of Administration for the University of Southern California Alzheimer’s Therapeutic Research Institute (USC ATRI). She is involved with coordination of ACTC and ATRI activities and interfaces with all other Units, Committees, project teams, and clinical sites. Areas of responsibility and oversight include Regulatory Affairs, Fiscal Management, Contracts, Human Resources, Quality Assurance, and the ATRI Recruitment group. She also serves on the ACTC Recruitment Unit, as well as, the Executive and IDEAS-CT Committees.
Michael Donohue, PhD
Dr. Donohue co-leads the Biostatistics Unit. His primary interests include modeling the long-term, multivariate evolution of Alzheimer’s Disease, and utilizing these models to inform ACTC clinical trial design. Dr. Donohue guides the unit on the use of analytic power calculations and model-based simulations to drive clinical trial design decisions regarding sample size, duration, analysis approach, and outcome measures. He helps ensure that ACTC trials are conducted with maximum statistical power and minimum participant burden. He helped develop the first Preclinical Alzheimer’s trials, and the Preclinical Alzheimer’s Cognitive Composite (PACC). Research funded by his R01 lead to a novel hierarchical Bayesian model, the Latent Time Joint Mixed-Effects Model (LTJMM). The model can simultaneously estimate long-term trajectories of several disease markers and includes a subject-specific latent time shift parameter to account for heterogeneity in disease stage.
Michael Rafii, MD, PhD
Dr. Rafii also serves as director of the Medical Safety Unit of the Alzheimer’s Clinical Trials Consortium (ACTC) and co-director of the Clinical core of the Alzheimer’s Disease Neuroimaging Initiative (ADNI). He provides safety oversight to ATRI’s entire portfolio of clinical trials. He is a scientific reviewer for the NIH and the Alzheimer’s Association. His work has been featured in the New York Times, Chicago Tribune, Washington Post, Wall Street Journal and National Public Radio (NPR).
Michael Weiner, MD
Michael Weiner, MD, is Co-Lead of the ACTC MRI Unit. He is a Professor in Residence in Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco. He is Principal Investigator of the Alzheimer’s Disease Neuroimaging Initiative, which is the largest observational study in the world concerning Alzheimer’s Disease. He is the former Director of the Center for Imaging of Neurodegenerative Diseases (CIND) at the San Francisco Veterans Affairs Medical Center. After graduating from the Johns Hopkins University in 1961, he obtained his M.D, from SUNY Upstate Medical Center in Syracuse, New York in 1965, and he completed his internship and residency in Medicine from Mt. Sinai Hospital in 1967. From 1967-1968, Dr. Weiner completed a residency and clinical fellowship in Metabolism from Yale-New Haven Medical Center. In 1970, he completed a research fellowship in Nephrology from Yale University School of Medicine and a research fellowship in Biochemistry from the University of Wisconsin Institute for Enzyme Research in 1972, followed by a joint appointment in the Department of Medicine, Renal Section from the University of Wisconsin Institute in 1972. In 1974 he became an Assistant Professor of Medicine (Nephrology) at Stanford University, and in 1980 he became an Associate Professor of Medicine (Nephrology) at UCSF. In 1983, he established the Magnetic Resonance Unit at the San Francisco VA Medical Center, which became the Center for Imaging of Neurodegenerative Diseases in 2000. In 1990, he became a Professor of Radiology, Medicine, Psychiatry and Neurology at UCSF.
Dr. Weiner’s research activities involve the development and utilization of MRI and PET for investigating and diagnosing neurodegenerative diseases. In 1980, Dr. Weiner was one of the first to perform MRS on an intact animal, and subsequently pursued his goal to develop MRI/S as a clinical tool. In 1988, his group used MRS to show that the amino acid N acetyl aspartate (NAA), a marker of healthy nerve cells, is reduced in the epileptic focus in the brain. In 2004, Dr. Weiner’s group reported that reduced NAA predicts development of Alzheimer’s disease in mildly impaired elderly subjects. During the past 25 years he has worked to develop and optimized the use of MRI, PET, and blood based biomarker methods to diagnose Alzheimer’s disease and other neurodegenerative disorders. Also, Dr. Weiner’s research focuses on monitoring effects of treatment to slow progressions in Alzheimer’s disease, and detecting Alzheimer’s disease early in patients who are not demented, but risk subsequent development of dementia. He is the Principle Investigator of the Alzheimer’s Disease Neuroimaging Initiative, a 14-year national longitudinal study of over 1,500 subjects which is aimed at validating biomarkers for Alzheimer’s disease at 60 sites across the USA and Canada for cognitive testing, MRI, PET, and lumbar puncture. He also launched the BrainHealthRegistry.org which is an internet based registry with the overall goal of accelerating development of effective treatments for brain diseases. This website registry recruits, screens, and longitudinally monitors brain function on more than 60,000 participants. His overall research goals are to participate in the development of effective treatments and methods for early detection of Alzheimer’s disease and other brain disorders. Recently he has focused on developing inexpensive, scalable, tools to identify normal elders at risk for cognitive decline and dementia, and to provide the Brain Health Registry software to facilitate the work of other investigators. Dr. Weiner has mentored over 120 postdoctoral fellows, has authored more than 860 peer-reviewed research papers and 62 book chapters. He holds 19 separate research grants. He has received numerous honors including the Middleton Award for outstanding research in the Veterans Administration, the Ronald and Nancy Reagan Award for research from the Alzheimer’s Association, and the Potamkin Prize for research in Picks Disease, Alzheimer’s disease, and other neurodegenerative disorders from the American Association of Neurology and the American Brain Foundation.
Gustavo Jimenez-Maggiora, MBA
Gustavo Jimenez-Maggiora, MBA, is the Director of Informatics for the Alzheimer’s Therapeutic Research Institute (USC ATRI), Keck School of Medicine, at the University of Southern California, providing the informatics and data management leadership for all research programs conducted and managed by the Institute. As an informatician with an applied research interest in the field of neurology, he provides informatics and data management leadership as a co-investigator on several national and international initiatives and programs.
Gustavo is the Director of the Alzheimer’s Clinical Trials Consortium (ACTC) Informatics Unit. He leads the development of the ACTC Informatics Platform (ACTC-IP) to support the ACTC program and its scientific aims. The ACTC-IP serves as an extensible, secure, and scalable information, collaboration, and process management infrastructure to facilitate the effective execution of program- and study-related research activities by ACTC Units, investigators, study teams, and performance sites. The ACTC-IP provides facilities to collect, clean, store, process, analyze, visualize, audit, and disseminate scientific, operational, and administrative data using standardized data models, formats, and taxonomies.
Gustavo also serves as the informatics lead for the Alzheimer’s Disease Neuroimaging Initiative (ADNI) Clinical Core, the informatics co-lead for the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), the informatics core co-lead for the Longitudinal Early-Onset Alzheimer’s Disease Study (LEADs), and the lead informatician for the Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (TRC-PAD).