A safety trial in young and elderly healthy subjects has been completed. The trial was completed at PRA Health Sciences (Lenexa, Kansas) with oversight by Accellient Partners (Waltham, MA). This trial included single and multiple ascending doses with the goal of assessment of safety and plasma pharmacokinetics.
This is a double-blinded, randomized controlled trial focused on safety and assessment of exploratory endpoint and biomarker measures in subjects with mild-moderate Alzheimer’s disease (clinicaltrials.gov NCT03069014; EudraCT: 2018-001071-20). The principal investigator is Dr. Manfred Windisch (CEO, President, NeuroScios, Graz, Austria). Treatment duration is 6 months and trial groups include placebo, low-dose and high-dose. Enrollment and testing of approximately 240 subjects will be completed in June 2020. Trial sites are located in Sweden, Germany, Austria, the Czech Republic and Spain. Outcome domains include: cognitive testing (design and oversight, John Harrison, Honorary Senior Lecturer, Imperial College London, Principal Consultant at Metis Cognition Ltd.); brain imaging (design and oversight, Agneta Nordberg, Professor in Clinical Neuroscience, Director Center for Alzheimer Research, Translational Alzheimer Neurobiology Karolinska Institute, Stockholm, Sweden) and cerebrospinal fluid biomarkers (design and oversight, Kaj Blennow, Professor and Head, Clinical Neurochemistry, Sahlgrenska University Hospital, University of Gothenburg, Sweden). Data monitoring and statistical analyses is managed by Dr. David Fleet and Data Magik (Salisbury UK). Data analysis is scheduled for completion during Q4 2020.
A second trial in healthy subjects was completed at the Clinical Trials Unit, Department of Pharmacology and Therapeutics, Universidad Autónoma de Madrid, Spain with oversight by NeuroScios with a focus on assessment of safety and plasma/cerebrospinal fluid pharmacokinetics.
Clinical Trials – LM11A-31-BHS Program