Studying the Reversal of Cognitive Decline
QuesGen served as the Clinical Research Organization (CRO) as well as providing the Data Management and Research Platform for this study.
RELATIONSHIP
QuesGen worked with Four Winds Foundation via Evanthea, LLC
STUDY SIZE
25 patients studied for
9 months
STUDY CHARACTERISTICS
Subjects ages 45-76 with cognitive decline
Executive Summary
This protocol looked to understand the impact of inflammation, environmental toxins, gut health, and other lifestyle-related factors (diet, exercise, sleep, stress).
QuesGen was proud to be the CRO for the study, tasked with editing the protocol, submitting it to the IRB, working through identified issues, and tracking all participants through the process to ensure schedule requirements were met. Utilizing QuesGen’s proven brain health model and research platform, QuesGen optimized the data curation and analysis for the ReCODE study and enabled continuous improvement of encounter processes, user interface, Electronic Case Report Forms (eCRFs), data models, and quality control.
QuesGen Role:
- CRO services, including IRB and protocol services
- Provided a proven brain health data model
- Electronic Case Report Forms Library of over 80 eCRFs
- ReCODE Study data validation and centralized data curation
- Handled all financial aspects of the study
Overarching Project Goal
IMPROVEMENT IN NEUROCOGNITIVE
DECLINE FOR PATIENTS WITH ALZHEIMER’S
ReCODE Study Overview
This involved the analysis, design, and implementation of the QuesGen Base system into a production Data Model and Research Platform optimized for the ReCODE study.
Study Setup and Support
QuesGen supplied a preexisting library of eCRFs and the creation of multiple custom eCRFs explicitly designed for the study.
The QuesGen team developed a ReCODE screening and enrollment process to ensure that participants who met the requirements were scheduled with providers to minimize their enrollment burden.
With QuesGen’s data validation and curation capabilities, all data was validated upon entry, and any missing or incomplete data were identified.
Additional support included creating ReCODE’s participant portal supporting participant outreach with electronic Surveys; electronic Participant Reported Outcomes (ePRO)/Ecological Momentary Assessment (EMA) reminders. Additionally, QuesGen handled all of the financial aspects of the study, including site and vendor compensation.
Results
The ReCODE protocol is now in clinical trials.
