Alzheimer’s Disease Risk Biomarker
In collaboration with scientists at Duke University Medical Center, a Cabernet Pharmaceuticals team described a genetics-based risk algorithm as a simple prognostic tool for assessing age-of-onset of Alzheimer’s disease in cognitively normal, elderly subjects (Roses et al, 2010, Roses et al, 2014, Lutz et al, 2016, Roses et al, 2016). The algorithm comprised APOE (apolipoprotein E) and TOMM40 (translocase of outer mitochondrial membrane) genes associated with Alzheimer’s. Cabernet assisted with filing a patent for a risk algorithm and sought a partner for a drug/device co-development program to validate the biomarker. Cabernet also presented to the Food and Drug Administration, through a Voluntary Exploratory Data Submission, a clinical-development strategy to qualify a biomarker and test a potential therapeutic to delay the onset of mild cognitive impairment due to Alzheimer’s in cognitively normal but high-risk individuals. A pre-study, “enabling” phase was then initiated in collaboration with clinical-site teams from the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center at Duke and from Imperial College London. This step focused on preparing pivotal research sites for accelerated recruitment by identifying “research-ready” subject populations within site-specific registries before enrollment commenced. (Romero et al, 2014, Hayden et al, 2014, Larsen et al, 2015).
The resulting Phase III clinical trial, called the TOMMORROW study and sponsored by the Zinfandel-Takeda alliance, is under way and fully enrolled.