MEDICAL &SAFETY CORE The Medical &Safety Core of the Alzheimer Disease Cooperative Study (ADCS) serves to: provide supervision and direction for the project as a whole, coordinate the activities of the sites and the Project Directors with each other and make decisions involving policy, priority and flow of work as well as allocation of resources and personnel, provide fiscal control for the operation of the ADCS, coordinate the development and implementation of new protocols, oversee the work of the various committees, maintain subcontracts with sites and vendors, develop and implement recruitment strategies, and maintain contact with industry, the media and NIA. The Medical &Safety Core also codes medical adverse events, classifies concomitant medications used in ADCS trials with standard classification and nomenclature schemes, and provides clinical trial safety reports to the Data and Safety Monitoring Board.
Medical and Safety Core: The Administrative and Medical Cores work closely together to generate safety reports for distribution to participating sites for submission to their respective IRBs and to provide safety data summaries to the Project Directors to assist them in preparing the annual report for each trial. The two cores together also provide guidance to the Project Directors with respect to the content, coding, format, and timelines for reporting serious adverse events to the FDA and participating IRBs.
|Besser, Lilah; Kukull, Walter; Knopman, David S et al. (2018) Version 3 of the National Alzheimer's Coordinating Center's Uniform Data Set. Alzheimer Dis Assoc Disord 32:351-358|
|Jacobs, Heidi I L; Hedden, Trey; Schultz, Aaron P et al. (2018) Structural tract alterations predict downstream tau accumulation in amyloid-positive older individuals. Nat Neurosci 21:424-431|
|Buckley, Rachel F; Mormino, Elizabeth C; Amariglio, Rebecca E et al. (2018) Sex, amyloid, and APOE ?4 and risk of cognitive decline in preclinical Alzheimer's disease: Findings from three well-characterized cohorts. Alzheimers Dement 14:1193-1203|
|Donohue, Michael C; Sperling, Reisa A; Petersen, Ronald et al. (2017) Association Between Elevated Brain Amyloid and Subsequent Cognitive Decline Among Cognitively Normal Persons. JAMA 317:2305-2316|
|LaPoint, Molly R; Chhatwal, Jasmeer P; Sepulcre, Jorge et al. (2017) The association between tau PET and retrospective cortical thinning in clinically normal elderly. Neuroimage 157:612-622|
|Sawda, Christine; Moussa, Charbel; Turner, R Scott (2017) Resveratrol for Alzheimer's disease. Ann N Y Acad Sci 1403:142-149|
|Buckley, R F; Sparks, K P; Papp, K V et al. (2017) Computerized Cognitive Testing for Use in Clinical Trials: A Comparison of the NIH Toolbox and Cogstate C3 Batteries. J Prev Alzheimers Dis 4:3-11|
|Raman, Mekala R; Tosakulwong, Nirubol; Zuk, Samantha M et al. (2017) Influence of preeclampsia and late-life hypertension on MRI measures of cortical atrophy. J Hypertens 35:2479-2485|
|Respondek, Gesine; Kurz, Carolin; Arzberger, Thomas et al. (2017) Which ante mortem clinical features predict progressive supranuclear palsy pathology? Mov Disord 32:995-1005|
|Rentz, Dorene M; Mormino, Elizabeth C; Papp, Kathryn V et al. (2017) Cognitive resilience in clinical and preclinical Alzheimer's disease: the Association of Amyloid and Tau Burden on cognitive performance. Brain Imaging Behav 11:383-390|
Showing the most recent 10 out of 490 publications