Novartis pharmaceutical initiated the Generation S2 clinical trial in the United States in August 2017, and brought it to Europe for the first time through the BBRC. The trial has the collaboration of the pharmacist Amgen and the Banner Alzheimer's Institute.
The study is evaluating the effects and safety of a drug, CNP520, on cognition and global clinical status in people at risk of developing clinical symptoms of Alzheimer's disease by age, genetic predisposition and amyloid protein loading in the brain.
The trial is phase II and III, randomized, double-blind, with placebo control and parallel groups. Participants are between 60 and 75 years old, and must have at least one allele 4 of the APOE gene, and in the case of being heterozygous, a high load of amyloid beta protein in the brain. Therefore, the study implies the revelation to the participant about his possible increased risk of presenting in the future cognitive problems that could, in some cases, lead to an Alzheimer's disease.
For 5 and 7 years, participants will receive a placebo or treatment. CNP520 is a BACE inhibitor administered orally, and is designed to reduce amyloid beta production in the brain. Participation in the Generation S2 clinical trial involves the realization of Positron Emission Tomography (PET) or lumbar puncture, brain magnetic resonance imaging and cognitive tests, among others.
The trial will be conducted in approximately 2,000 people around the world.