Enrollment has concluded for a Phase III trial of the genetic-based biomarker risk assignment algorithm (BRAA), which will assess the safety and effectiveness of investigational therapy pioglitazone 0.8 mg SR.
Researchers said the drug may delay the onset of mild cognitive impairment (MCI) in patients living with Alzheimer's disease (AD) and patients deemed likely to develop AD.
Dubbed the Tommorrow trial, the study will involved more than 50 sites all over the world and place about 3,500 subjects, ages 65 to 83, in a randomized, double-blind, placebo-controlled, parallel-group trial.
The trial will be conducted over a five-year period.
Pioglitazone 0.8 mg SR is being developed by researchers at Osaka, Japan-based Takeda Pharmaceutical Co. Limited and Zinfandel Pharmaceuticals Inc. of Chapel Hill, North Carolina.
Previous studies indicated that patients with MCI are at a higher risk of developing AD or other forms for dementia.
More information on the Tommorrow trial is available at www.clinicaltrials.gov.
