The Clinical Significance of Incidental White Matter Lesions on MRI Amongst a Diverse Population with Cognitive Complaints (INDEED)

Grants and Contracts Details

Description

Diverse VCID: White Matter Lesion Etiology of Dementia in Diverse Populations SCOPE OF WORK The purpose of this research is to better understand how vascular health and abnormal white matter signals in the brain affect thinking. Damage to the blood vessels in the brain (vascular brain injury) can result in vascular cognitive impairment and dementia (VCID). This study will improve our understanding of how poor vascular health causes white matter hyperintensities (WMH) and VCID and potentially lead to treatments aimed at reducing VCID. In accordance with the protocol and procedures manual the Site Investigator(s) will provide the following: PERFORMANCE OF STUDY Institution agrees to conduct this Study in strict accordance with the Protocol, which is incorporated by reference herein, all applicable guidelines relevant to the conduct of clinical protocols, including, but not limited to the FDA, U.S. Office of Human Subject Protections, the Study Sponsor, the NIH, HIPAA, conditions imposed by the Institution’s IRB, and written instructions of UC Davis relative to the administration of the protocol. IRB APPROVAL, INFORMED CONSENT, AND HIPAA AUTHORIZATION The Institution shall ensure the Site Investigator obtains the approval of the Protocol and related Informed Consent Form from the Institution’s IRB. The Institution shall ensure each subject enrolling in the Study shall give his or her informed consent to participation by signing the Informed Consent Form in accordance with the Institution’s informed consent policies. The Institution shall provide a copy of the written Informed Consent Form to each Study subject or the subject’s legal representative. The site should make no change to the Protocol or the Informed Consent Form without prior written approval by UC Davis and the Institution’s IRB except when such change is necessary to eliminate apparent immediate hazard to Study subjects, or to comply with applicable local, state, or federal law, in which case Institution agrees to notify UC Davis and the Institution’s IRB immediately. The Institution shall ensure that each subject enrolling in the Study shall execute a HIPAA Authorization form approved by UC Davis and the Institution’s IRB in advance, to permit the use and disclosure of the subject’s protected health information (PHI). The HIPAA authorization shall expressly authorize disclosure of the subject’s PHI to the Site Investigator and UC Davis for any purpose directly related to the study. STUDY MATERIALS (Repository) All materials supplied by the UC Davis shall be used by the Site Investigator and Institution only as specified in the Protocol. The Institution agrees to handle, and store materials as specified in the Protocol; maintain records on use and disposition of any materials used in the Study according to the Protocol; and dispose of any materials provided by UC Davis according to UC Davis’ instructions. BIOLOGICAL SAMPLES The Parties will collect, retain, and use biological samples from subjects enrolled in the Study solely according to the Protocol consistent with the Informed Consent Form provided by UC Davis, approved by the IRB, and signed by the Study subject (i.e., the Informed Consent Form). PERSONNEL The 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. Ensure raters maintain current certification throughout the entire study. Assure compliance with all applicable regulations, including up-to-date training and certifications (Federal, NIH, State, Institutional, etc.). The Site Investigator and study personnel shall be available to the clinical monitors during on-site monitoring visits and access to patient source documentation and those portions of clinic charts that contain Study related information. Ensure prompt response to requests (administrative or data-related) from UC Davis, the National Alzheimer’s Coordinating Center (NACC) or Laboratory of Neuroimaging (LONI) by email, phone, or other communication tools. Ensure prompt notification to UC Davis of key 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 Submission of required regulatory documents to the Institution’s IRB, within 4 weeks of receipt of the protocol. Completed screening visit of first participant within 1 month of Site being approved to begin enrollment. Site will be expected to screen a minimum of 40 participants per quarter. Site will be expected to enroll a minimum of 11 participants per month. Site will be expected to enroll a minimum of 8 minority subjects (i.e., African American or Hispanic) per month. Site will be expected to screen and enroll up to 200 subjects within 18 months of completing all requirements to become an approved study site. Site will be expected to complete follow up visit #1 within 18-36 months of Study subject completion of baseline assessment. Site will be expected to complete follow up visit #2 within 36-48 months of Study subject completion of Follow-up visit #1. Enrollment will be open until 2,250 participants have been enrolled or as otherwise indicated by UC Davis. Site will be expected to select participants and implement a retention program to ensure participants are retained for the duration of the study to the greatest extent possible. Site will be expected to exercise full compliance with all procedures specified in the Protocol and in the procedures and imaging technical manuals. Site will be expected to exercise full compliance with the specified inclusion/exclusion criteria cited in the protocol. Site will ensure timely data entry into the Study electronic data capture, NACC and LONI for all study activity done by the site. Including response to data corrections and requests for participant activity within the time limits specified in the procedure’s manual. PROCEDURES Ensure proper informed consent is obtained prior to any study-related procedures being performed. Full compliance with specified inclusion/exclusion criteria cited in the protocol. Full compliance with all procedures specified in the protocols, in the Manual of Procedures, Specimen Collection protocol and Imaging Acquisition protocols. Carry out all evaluations within time limits specified in the Manual of Procedures for the protocol. 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. Proper collection, storage and shipment of laboratory specimens for safety monitoring, laboratory surveillance, compliance monitoring, biomarker research and storage for future research studies. Proper reporting of all adverse events (AE), with serious adverse events (SAE) being reported to UC Davis within 24 hours of site notification. And following subjects with AEs until the events have subsides, the conditions medically stable, or the participants are no longer available for follow up. Prompt response to requests (administrative or data-related) from UC Davis, NACC or LONI by email, phone or through data query. Data from the screening visit be entered in the online data entry forms within 90 days of being generated by Site. MRI data must be uploaded within 30 business days of imaging. Ensure scanner compliance by following specified imaging protocols as specified in the Technical Manuals for MRI by reporting any modifications to scanners to UC Davis, LONI and the Repository Core in case re-certification is required. Ability to procure any study materials and supplies not provided by UC Davis, NACC or LONI in order to conduct research-appropriate storage and accounting. STUDY PAYMENT TERMS Payments will be made quarterly for all subject visits accurately completed and verified, and submitted online to UC Davis, NACC, and LONI. All visits and procedures completed per protocol will be reimbursed according to the payment schedule. Following receipt of A) All Regulatory Documents; B) Signed Site Agreement; C) Approval of study start up; a startup fee covering IRB related expenses and general startup costs will be paid in the amount of $13,300. Payment for chart prescreening will be reimbursed at a rate of $25 per subject up to 350 subjects per site upon receipt of an invoice from the Institution with screening inventory form. Payment for conducting additional review of eligibility criteria on up to 50 unqualified participants per site will be reimbursed at a rate of $50 per subject upon receipt of an invoice from the Institution with an eligibility review form. Payment for an MRI Phantom Scan will be reimbursed at a rate of $1,000 per site upon receipt of the MRI certification form and an invoice from the Institution. Payment for an MRI set up fee will be reimbursed at a rate of $500 per site upon receipt of an invoice. Payment for additional MRIs will be reimbursed at a rate of $1,000 per scan up to 20 scans per site upon receipt of an invoice detailing the site name and number, subject ID, date, and reason for the additional MRI. Sites will be reimbursed for procedures completed per the DIVERSE VCID Site Reimbursement Plan on the following page. Sites will have two weeks after the end of the quarter to complete uploading of all data prior to generation of site reimbursement statements. DIVERSE VCID SITE Reimbursement Plan Baseline Follow-up #1 Follow-up #2 (0 - 18 months) (18 - 36 months) (36 - 48 months) Screening per subject Rate # subjects Total Brain MRI per subject Participant Fee per subject $ 1,000 200 $ 200,000 Review of Eligibility Criteria per subject $ 50 200 $ 10,000 Informed Consent $ 50 200 $ 10,000 $ 50 200 $ 10,000 Assessments Vitals Rate # Subjects Total Rate # Subjects Total Blood Draw $ 10 200 2,000 Clinical Labs per subject $ 10 200 $ 2,000 $ 25 200 $ 2,000 $ 10 200 $ 5,000 Demographics per subject $ 25 200 $ 5,000 $ 75 200 Family Health History per subject $ 75 200 $ 15,000 $ 5,000 $ 25 200 $ 15,000 Concomitant Medications per subject $ 25 200 $ 5,000 $ 25 200 Physical and Neurological Exam per subject $ 25 200 $ 5,000 $ 75 200 $ 15,000 $ 75 200 $ 5,000 CDR per subject $ 25 200 $ 5,000 $ 50 200 15,000 NPI-Q per subject $ 75 200 $ 15,000 $ 35 200 $ 5,000 $ 25 200 $ 10,000 GDS per subject $ 50 200 $ 10,000 $ 25 200 $ 15,000 $ 75 200 $ Neuro findings and Clinical Judgement per subject $ 35 200 $ 7,000 $ 50 200 $ 10,000 $ 50 200 $ 7,000 MOCA per subject $ 25 200 $ 5,000 $ 35 200 $ 7,000 $ 35 200 $ 5,000 Neuropsych Battery per subject $ 50 200 $ 10,000 $ 100 200 $ 5,000 $ 25 200 $ 10,000 Clinical Diagnosis per subject $ 35 200 $ 7,000 $ 20 200 $ 10,000 $ 50 200 $ 7,000 List learning per subject $ 100 200 $ 20,000 $ 25 200 $ 7,000 $ 35 200 $ 20,000 eCog per subject $ 20 200 $ 4,000 $ 15 200 $ 20,000 $ 100 200 $ 4,000 Blood Processing and Shipping per subject $ 25 200 $ 5,000 $ 50 200 $ 4,000 $ 20 200 $ 5,000 Data Entry per subject $ 15 200 $ 3,000 $ 50 200 $ 5,000 $ 25 200 $ 3,000 Participant Fees per subject $ 50 200 $ 10,000 $ 100 200 $ 3,000 $ 15 200 $ 10,000 Vascular Questionnaire per subject $ 50 200 $ 10,000 $ 10,000 $ 50 200 $ 10,000 Life''s Simple 7 per subject $ 50 200 $ 10,000 $ 1,000 200 $ 10,000 $ 50 200 $ 20,000 Diet questionnaire per subject $ 25 200 $ 5,000 $ 1,765 $ 20,000 $ 100 200 $ MRI Scan per subject $ 25 200 $ 5,000 200,000 per subject $ 25 200 $ 5,000 353,000 Total per subject $ 1,990 $ 398,000 $ 200,000 $ 1,000 200 $ $ 353,000 $ 1,765 $
StatusFinished
Effective start/end date9/1/218/31/22

Funding

  • University of California Davis: $2.00

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