Accera, Inc., a privately-held, commercial-stage, healthcare company focused on the discovery and development of innovative clinical applications to address acute and chronic neurodegenerative diseases, announced today the initiation of a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD). AC-1204 is a formulation of caprylic triglyceride designed to improve cognitive function in mild to moderate Alzheimer's disease.
The study, (Titled: NOURISH AD), "A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects with Mild to Moderate Alzheimer's Disease (AD) with an Optional 26 Week Open-Label Extension," will examine the efficacy of 26 weeks daily administration of AC-1204 compared with placebo among participants diagnosed with mild-to-moderate AD.
"With the recent investment we received from Nestlé Health Science, we're eager to generate additional clinical data illustrating the effectiveness of our product in patients with mild-to-moderate Alzheimer's disease," said Holger Kunze, president and CEO of Accera. "We believe we have a truly innovative approach that will meet the needs of patients in this overwhelmingly underserved market."
Accera's technology addresses the well-recognized physiological hallmark of the brain's inability to optimally metabolize glucose by providing an alternative energy source for brain cells. In previous clinical trials, this approach has been shown to safely improve memory and cognitive function by inducing safe, therapeutic, tolerable and predictable levels of ketosis that improves memory in patients with mild-to-moderate AD.
The study will be a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. It will be conducted at approximately 60 clinical sites in the US and is expected to enroll more than 400 patients. This study will evaluate the effects of once daily dosing of AC-1204 for 26 weeks on cognition, pharmacokinetic measures, activities of daily living, resource utilization, and quality of life among subjects with mild-to-moderate AD.
The primary endpoint will examine the effects of AC-1204 on memory and cognition as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) after 26 weeks among both carriers and non carriers of the epsilon 4 variant of the gene apolipoprotein E (APOE4). Previous studies demonstrated proof of concept for the company's unique approach.