Takeda and Zinfandel complete enrolment for pioglitazone drug trial

Takeda and Zinfandel Pharmaceuticals have announced the completion of enrolment for their new phase III clinical trial TOMORROW.

The global trial aims to investigate a genetic-based biomarker risk assignment algorithm (BRAA) and evaluating the safety and efficacy of the investigational drug pioglitazone as a means of delaying the onset of mild cognitive impairment due to Alzheimer's disease.

Cognitively normal individuals projected to be at high risk are determined using the BRAA, which assesses three components: increased age, levels of apolipoprotein E and Translocase of Outer Mitochondrial Membrane genotypes.

The first two of these factors have previously been shown to indicate elevated risk of Alzheimer's, but neither is sufficiently sensitive or specific on their own, meaning the addition of the third factor could make a big difference.

This study is important as individuals with mild cognitive impairment are at an increased risk of developing Alzheimer's or another form of dementia, with conversion rates of approximately 15 percent per year.

Approximately 3,500 subjects have been enrolled for TOMORROW across more than 50 centres in the US, UK, Germany, Switzerland and Australia. Results are expected in around five years.