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 $
Status | Finished |
---|---|
Effective start/end date | 9/1/21 → 8/31/23 |
Funding
- University of California Davis: $221,452.00
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