Alzheimer's Disease Neuroimaging Initiative (ADNI3)[Diversity Taskforce Project]

Project: Research project

Project Details

Description

The ADNI Clinical Core, co-directed by Ors. Paul Aisen and Ron Petersen, has three broad
aims: to provide operational support to ADNI, to characterize the clinical and cognitive
features of the ADNI cohorts, and to develop new clinical trials designs to facilitate AD drug
development. The Clinical Core is responsible for guiding the recruitment and follow-up of
ADNI subjects, the implementation of inclusion/exclusion criteria for new subjects,
the implementation of all cognitive and clinical assessments, adjudication of clinical diagnostic decisions, and management of any safety issues that occur. Further, the Clinical Core tabulates and analyzes the cognitive and clinical data, and, in collaboration with the other ADNI cores, analyzes the relationships among clinical and cognitive data and biochemical and imaging biomarker data. The Clinical Core is also responsible for the utilizing the ADNI clinical and biomarker data to develop novel trial designs, focusing on pre-dementia populations, to facilitate the development of new therapeutic interventions. The ADNI Coordinating Center, a major part of the Clinical Core, is based at USC and utilizes the cores of the Alzheimer's Therapeutic Research Institute (ATRI); oversight is provided by Dr. Aisen, Director of the ATRI. Coordinating Center responsibilities include: supporting the recruitment and retention of subjects, establishment and maintenance of subcontracts with the sites, tracking visit activities and providing payments for the subcontracts, assuring human subjects regulatory compliance, supporting communications, clinical site monitoring, reporting to and interactions with the Data and Safety Monitoring Board, developing, updating and distributing study documents (protocols, training and procedures manuals), conducting the investigators' meeting, coordinating and organizing the clinical trial activities at the sites, tracking enrollment and assigning open enrollment spots, managing and distributing study supplies, acting as the primary point of contact for the sites, and developing and maintaining the data collection system. In addition, the USC biostatisticians work collaboratively with the biostatistics Core at UC Davis, and more specifically support the clinical trial work of the clinical core.
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StatusActive
Effective start/end date8/1/207/31/22

Funding

  • University of Southern California (137206820//U19AG024904-12)
  • National Institute on Aging (137206820//U19AG024904-12)

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