Alzheimer's Disease Cooperative Study # A4 Study

  • Jicha, Gregory (PI)
  • Murphy, Richard (CoI)
  • Caban-Holt, Allison (Former CoI)
  • Smith, Charles (Former CoI)

Grants and Contracts Details


SCOPE OF WORK The A4 study is designed to test the hypothesis that solanezumab, will slow decline on a cognitive composite measure designed to be sensitive to early decline in the preclinical stages of AD. In accordance with the protocol and procedures manual the Site Investigator(s) will provide the following: PERSONNEL 1. Site must have in place a qualified study coordinator and all other necessary personnel to ensure quality control of all primary and secondary end points. 2. Ensure CDR and ADAS raters maintain current certification throughout the entire study. 3. Assure compliance with all applicable regulations, including up-to-date training and certifications (Federal, NIH, State, Institutional, etc.) 4. Availability of Principal Investigator and study personnel to the clinical monitors during on-site monitoring visits and access to patient notebooks, source documentation, and to those portions of the clinic charts that contain study related information. 5. Prompt notification to the Coordinating Center of all study staff changes. This includes changes in staff roles for clinical teams, new staff and staff leaving the study; and/or site, telephone, email and address changes. MILESTONES 1. Submission of required regulatory documents to the Sites’ IRB, within 4 weeks of receipt of the protocol. 2. Prompt preparation and submission of a recruitment and retention plan. 3. Completed Screening Visit of first participant within 1 month of Site being approved to begin enrollment. 4. Screen at a minimum 8-10 participants per month. 5. Enroll at a minimum 2 participants per quarter. 6. Selection of participants and implementation of a retention program to ensure participants are retained for the duration of the study to the greatest extent possible. PROCEDURES 1. Ensure proper informed consent is obtained prior to any study-related procedures being performed. 2. Full compliance with specified inclusion/exclusion criteria cited in the protocol. 3. Full compliance with all procedures specified in the protocol, in the procedures manual and imaging technical manuals. 4. Carry out all evaluations within time limits specified in the procedures manual for the protocol. 5. Proper collection and submission of all required online data entry forms within the time limits specified in the procedures/technical manual(s) for the protocol. 6. Proper collection, storage and shipment of laboratory specimens for safety monitoring, laboratory surveillance, compliance monitoring, biomarker research and storage for future research studies. 7. Proper reporting of all adverse events (AE), with serious adverse events (SAE) being reported to the ATRI within 24 hrs of site notification. And following participants with AEs until the events have subsided, the conditions are considered medically stable, or the participants are no longer available for follow up. 8. Prompt response to requests (administrative or data-related) from the Coordinating Center by email, phone, or through data query tool. 9. It is required that data from the screening visit be entered in the online data entry forms within 3 days of being generated by Site. Data from all subsequent visits within 5 days of being generated by Site. 10. MRI Data must be uploaded within 2 business days of imaging. 11. Ensure scanner compliance by following specified imaging protocols as specified in the Technical Manuals for MRI by reporting any modifications to scanners to the Coordinating Center and the MRI core (respectively) in case re-certification is required. 12. Ability to procure any study materials and supplies not provided by the Coordinating Center in order to conduct research-appropriate storage and accounting.
Effective start/end date12/1/157/21/22


  • University of Southern California: $358,468.00


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