Positive clinical results from a phase I trial evaluating the candidate drug NeuroRestore
AlzeCure Pharma has, in collaboration with CTC Clinical Trial Consultants, published positive clinical results from a phase I trial evaluating the candidate drug NeuroRestore ACD856.
In this phase 1 trial in healthy volunteers, ACD856 was well-tolerated after multiple dose administration, demonstrated a suitable pharmacokinetic profile, reached relevant exposure in the brain and exerted treatment-associated changes on CNS activity, supporting further clinical development. ACD856 is being developed for treatment of Alzheimer’s disease and cognitive dysfunction.
The study was managed by CTC and conducted at CTC’s First-in-Human research unit in Uppsala, Sweden. Concentrations of ACD856 in plasma, urine and cerebrospinal fluid were analysed by Lablytica Life Science. MIST (Metabolite in Safety Testing) analysis and metabolite profiling in plasma and urine was conducted by MetaSafe.
CTC Clinical Trial Consultants, Lablytica Life Science and MetaSafe are all part of the CTR Center for Translational Research group. The CTR group consists of six sister companies that offer phase I – III clinical study conduct, regulatory advice, DMPK/MIST and toxicology support, GLP-certified bioanalysis, and overall project strategy planning in the life science sector.
Results have been published in The Journal of Prevention of Alzheimer’s Disease within the article titled “Safety, Tolerability, Pharmacokinetics and Quantitative Electroencephalography Assessment of ACD856, a Novel Positive Allosteric Modulator of Trk-Receptors Following Multiple Doses in Healthy Subjects”. The article in full is available here: https://rdcu.be/di9sU