Summary
The Takeda TOMMORROW trial (NCT01931566) investigated a genetic-based biomarker risk assignment algorithm (BRAA) and evaluated the safety and efficacy of investigational drug pioglitazone 0.8 mg SR in delaying the onset of Mild Cognitive Impairment (MCI) due to AD in cognitively normal individuals projected to be at high risk, as determined by the BRAA. 3494 patients from the US and EU were enrolled. The trial was ultimately discontinued based on interim analysis.
About This Data Partner
Our mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. Duke University School of Medicine data sharing partnerships foster the principles of open science and data access from clinical studies. Our data sharing goals and policies include:
- Appropriate access to research information, so patient privacy is maintained, with the understanding that the nature of the study and sharing method will necessitate a range of privacy controls.
- Proper oversight with minimum barriers to data access, to prevent against misuse of data, while promoting new discovery.
- Maintaining utility of data, such that shared data can be used for new analyses.
- An expectation that results of analyses from shared data will similarly be shared.
- Acknowledgment of the work of original contributors.
Additional Information
Principal Investigator(s)
Kathleen Welsh-Bohmer
Data Available
Categorically, the GAAIN dataset is a sub-set of variables from the anonymized TOMMORROW dataset Duke received from Takeda. The variables in the GAAIN extract fall into the following categories: cognitive, clinical and demographic. Additional variables are included in the full TOMM40 dataset shared by Takeda through Vivli.