Phase III TOMMORROW trial of pioglitazone 0.8 mg SR has been terminated as a treatment for Alzheimers disease.Takeda.
Takeda Pharmaceutical Company Limited and its partner, Zinfandel Pharmaceuticals, Inc. announced that the global Phase III TOMMORROW trial has been terminated. The decision to discontinue the trial was based on a planned interim futility analysis, which showed an inadequate treatment effect with the investigational drug pioglitazone 0.8 mg SR in delaying the onset of mild cognitive impairment (MCI) due to Alzheimer�s disease (AD). This decision was not related to safety of the investigational product or study procedures.
The TOMMORROW trial was investigating a genetic-based biomarker risk assignment algorithm (BRAA) as well as evaluating the safety and efficacy of investigational drug pioglitazone 0.8 mg SR in delaying the onset of MCI due to AD in cognitively normal individuals projected to be at high risk, as determined by the BRAA. Results from the TOMMORROW trial will be presented at a future scientific meeting and efforts will be made to share the primary data with the scientific community.
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