Reversal of Cognitive Decline (ReCODE)

CASE STUDY: Prospective, observational study of 25 participants enrolled and followed for a 9-month period.

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

Developed by UCSF-trained neurologist Dale Bredesen, the ReCODE study looked to reverse the neurocognitive decline for patients with Alzheimer’s by considering a comprehensive lifestyle-related protocol.

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
Download a PDF of this case study!

Overarching Project Goal

IMPROVEMENT IN NEUROCOGNITIVE
DECLINE FOR PATIENTS WITH ALZHEIMER’S

ReCODE Study Overview

Working closely with the research team, QuesGen delivered a proven data model, development tools, and research processes to support rapid prototyping and piloting, which enabled the entire team to conduct research more efficiently, with less systematic risk and greater accuracy.

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 study showed the ReCODE protocol to be effective in reversing the neurocognitive decline, with 9 out of 10 participants showing a marked improvement.

The ReCODE protocol is now in clinical trials.

 

RECODE study

An Ideal Research Partner

Book a call with our team to review resources and learn more about our data management platform and suite of services, or call 650-777-7617.