Phase 1.

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.

Phase 2a.

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 has been completed (clinicaltrials.gov NCT03069014; EudraCT: 2018-001071-20). The principal investigator was Dr. Manfred Windisch (CEO, President, NeuroScios, Graz, Austria). Treatment duration was 6 months and trial groups included placebo, low-dose and high-dose. Approximately 240 subjects completed the trial. Trial sites were located in Sweden, Germany, Austria, the Czech Republic and Spain. The primary outcome was safety and exploratory outcome domains included cerebral spinal fluid (CSF) biomarkers, structural MRI, FDG-PET imaging and clinical testing. No significant safety concerns were identified in the trial. Drug treatment was associated with slowing of progression in the three biomarker areas of synaptic and inflammatory CSF biomarkers; structural MRI; and FDG-PET. ADAS-cog and MMSE scores demonstrated  progression of cognitive loss in the placebo group with a directionality of less progression in the drug group.

Next phase trials. 

Plans are underway for next-phase trials in Alzheimer’s subjects and in other neurodegenerative disorders.

Phase 1b.

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