The pharmaceutical company Araclon Biotech, from Grífols, is the sponsor of the AB1601 clinical trial, which started in February of 2018.
The aim of the study is to investigate the safety, tolerability and immune response of ABvac40 in people aged between 55 and 80 years old with amnestic mild cognitive impairment or very mild Alzheimer’s disease.
It is a Phase II multi-center, randomized, double-blind and placebo-controlled, with two treatment arms. On the one hand, the first group of participants receive a total of six subcutaneous injections of the drug (once every 4 weeks and the sixth at week 42). On the other hand, the control group receives placebo following the same process that the first group.
The research participants will have to undergo Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) and cognition tests, among others. 200 research participants will participate in the study, and they will be mostly recruited from centres in Spain, but also from France, Italy and Sweden.