MRT-Studie zur Untersuchung von Hirnvolumen bei Patienten mit kognitiven Beeinträchtigungen oder leichter Alzheimer-Demenz

PRImus-AD is a Phase II clinical trial investigating the efficacy and safety of an innovative drug in patients with mild cognitive impairment or mild Alzheimer's dementia. The study is randomised, double-blind, and placebo-controlled with three parallel study arms (two verum arms and one placebo arm). The aim of the clinical trial is to examine the effects of the active ingredient on neurotoxic protein structures and to evaluate the potential influence on disease progression. Randomised patients were treated for a minimum of 48 weeks up to 96 weeks. A total of 304 patients were divided into the three different treatment arms. An important read-out of the study is the analysis of magnetic resonance imaging (MRI) data to record changes in brain volume at both the individual and group levels. All MRI scans are generated using the same imaging protocol, T2* gradient echo, and diffusion weighted sequences. The study will be conducted in accordance with international standards for good clinical practice (ICH-GCP) and strict quality management guidelines. The schedule provides for a step-by-step evaluation, including the transfer and backup of image data, analysis, and final data