Description
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
Official source
Source: TED - Tenders Electronic Daily (Publications Office of the EU)
Always verify details on the official notice.
Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 1 month ago
More from this buyer
Full buyer profile1 open tender right now
- Germany - Research and development services and related consultancy services - MRI substudy No deadline published
Recent awards
Similar tenders
Market context
- Avg. open tender · Research & development
- €3,439,983
- Buyer track record on Aperlena
- 2 notices tracked · 1 awarded
Never miss a tender like this
17 new notices in Research & development in Germany in the last 7 days. Get an email when new ones appear. Free.
Set up my alert