Phase III study investigating effect of thiazolidinedione on mild cognitive impairment terminated early

The global Phase III TOMMORROW trial has been terminated. The TOMMORROW trial investigated a genetic-based biomarker risk assignment algorithm (BRAA) as well as evaluated the safety and efficacy of investigational drug pioglitazone 0.8 mg SR in delaying the onset of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) in cognitively normal individuals projected to be at high risk, as determined by the BRAA.

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 MCI due to AD. The decision was not related to safety of the investigational product or study procedures.

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, including the performance of the genetic-based biomarker risk assignment algorithm.

Source: press release Takeda January 25, 2018