BioCentury
ARTICLE | Clinical News

Biomarker risk assignment algorithm: Phase III started

September 16, 2013 7:00 AM UTC

Takeda and Zinfandel began the double-blind, international Phase III TOMMORROW trial of oral AD-4833 once daily for up to 5 years and the biomarker risk assignment algorithm in about 5,800 cognitively normal subjects ages 65-83. Subjects who are assessed as low risk by the biomarker risk assignment algorithm will receive placebo while those assessed as high risk will receive AD-4833 or placebo. AD-4833, a thiazolidinedione (TZD) PPAR gamma agonist insulin sensitizer, is marketed as Actos pioglitazone for Type II diabetes. The genetic-based biomarker risk assignment algorithm is based on APOE and TOMM40 genotypes and age, and is being evaluated in the trial to determine the risk of individuals developing MCI due to AD within 5 years. ...