2025/01/28 by Holger Rosenbrock, Michael Desch, Glen Wunderlich +1 · 1 voice
Medicine · #Diet and metabolism studies
paper · pdf · doi:10.1080/14796708.2024.2434415
openalex publication_date 2025/01/28 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/25
Plain Language SummaryWhat is this summary about?This article provides an overview of an investigational medication called iclepertin that is in clinical development for the treatment of cognitive symptoms in people diagnosed with schizophrenia. Iclepertin (BI 425809) is being developed as a glycine transporter 1 (GlyT1) inhibitor.This article also includes a description from coauthor Carlos Larrauri of what it is like to live with cognitive symptoms. Carlos Larrauri is a patient advocate and mental healthcare provider with a diagnosis of schizophrenia.Why is this important?Many people living with cognitive symptoms due to schizophrenia may face challenges with taking part in day-to-day activities and need support. Despite this, there are currently no approved pharmaceutical treatments for these symptoms.What are the key takeaways?According to preclinical studies in rodents, iclepertin improves cognitive function. Phase I and II clinical trials have demonstrated that iclepertin tablets at daily doses of 10 and 25 mg improve cognition in people living with schizophrenia, while being generally safe and well tolerated. Three multinational, Phase III trials assessing the safety and efficacy of iclepertin 10 mg tablets in people living with schizophrenia are underway. There is also an ongoing open-label extension trial to further assess safety. If these Phase III trials are successful, iclepertin may become the first once-daily pharmaceutical treatment to be approved for the treatment of cognitive symptoms in people living with schizophrenia.How to say…Iclepertin: ih-cluh-per-tinSchizophrenia: skits-uh-free-nee-uhGlycine: gly-seenGlutamate: gloo-ta-mateCognition: cog-ni-shunPlacebo: pluh-see-bohClinical development: The process by which a medicine is brought to market.Glycine transporter 1 (GlyT1): A protein that moves glycine, an amino acid neurotransmitter, from the synapse back into the nerve and other brain cells. GlyT1 reduces the amount of glycine in the synapse and helps to end and/or limit the increased nerve activation being transmitted to the next nerve cell (see ‘What is iclepertin?’ section for more information).Cognitive symptoms due to schizophrenia: One of the three symptom groups, which may be experienced by people diagnosed with schizophrenia. Cognitive symptoms include impaired memory, difficulty expressing thoughts, decreased attention span, difficulty with reasoning or problem solving and reduced speed of processing information.Preclinical studies: A stage of research when a new drug is tested in animals or human cells/tissue.Phase I trial: Clinical trials using a small number of healthy volunteers to determine the appropriate dose of a new drug and assess its potential safety.Well tolerated: When most people can take a drug without experiencing any serious side effects or discomfort.Phase II and III trials: Clinical trials using a small (Phase II) and large (Phase III) number of participants who have a specific disease or condition to determine how well a new drug may work to treat the condition of interest. They also identify any possible safety concerns that may be related to the new drug.Open-label: A type of clinical trial in which both the participant and the researcher know the drug that is being administered.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here