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FKB-Forskningssentre for klinisk behandling

Neuro-SysMed: A Systems Medicine Approach to Restructure Norwegian Clinical Neurology

Alternative title: Neuro-SysMed: Forskningssenter for klinisk behandling i nevrologi

Awarded: NOK 160.0 mill.

Project Number:


Project Period:

2019 - 2027


Partner countries:

Neuro-SysMed is a Centre for Clinical Treatment Research in multiple sclerosis (MS), Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS) and dementia. The Centre is hosted by Haukeland University Hospital in collaboration with the University of Bergen, and Haraldsplass Deaconess Hospital. The overarching aim of Neuro-SysMed is to establish new therapies able to arrest disease progression, ameliorate symptoms, or optimize care for individuals with these diseases. Towards this goal, the Center conducts national clinical studies and translational research. To maximize added value, the center includes data and samples from the trials in systems medicine analyses that integrates multimodal study data with the aim of classifying patients according to underlying disease mechanisms and treatment response, as well as developing biomarkers for personalized medicine. Within MS, the Center conducts 13 clinical studies and research projects. Early high-efficacy treatment is studied in the OVERLORD-MS study, which compares the efficacy and safety of rituximab (RTX) and ocrelizumab (OCR) in newly diagnosed MS. This study also extends into a switch study to evaluate whether the effect is preserved when switching from OCR to RTX. The RAM-MS study examines the effect of autologous hematopoietic stem cell transplantation, compared to other standard high-efficiency treatments, in MS with breakthrough activity due to therapy failure. Samples from these studies are used in a biomarker study exploring personalized anti-CD20 (RTX) and HSCT treatment. Another biomarker study analyzes microglia activation in chronic active MS-lesions from brain tissue samples. The 3TR-IMI-Horizon study is yet another biomarker study that evaluate disease modifying treatment responses in MS. The COVID-19 VACCINE study investigates how MS drugs and especially RTX affect the both clinical and immune effects of COVID-19 vaccination. Progressive MS is being studied in SMART-MS, which investigates whether autologous mesenchymal stem cells can repair neurological tissue damage. The NORSEMAN-MS study investigates whether nicotinamide riboside can slow disease progression in progressive MS. The FlowOX-MS study examines whether pulsed negative pressure treatment in the legs can relieve spasticity and pain in MS. The results are fed forward to a placebo-controlled Scandinavian study. The TAF-MS 1 and 2 studies will investigate whether tenofovir alafenamide fumarate affect chronic Epstein-Barr virus infection in MS, and whether this can affect disease activity. Within neurodegeneration (PD, dementia, ALS), the Center conducts 18 clinical studies and other projects, some of which are highlighted here. Our previously published NADPARK study has nominated NAD-replenishment therapy as a disease-modulating strategy for neurodegeneration. This is currently being explored in multiple studies across all four disease-groups. The NR-SAFE study was recently completed revealing that high-dose NR treatment (3000 mg) is safe and provides clinical improvement in PD. The NO-PARK study examines whether NR treatment can slow the progression of PD, while NO-PARK_extension assesses the long-term safety of NR treatment. N-DOSE and N-DOSE AD will determine the optimal dose of NR in PD and Alzheimer's disease, respectively, while NADbrain is a pharmacokinetic study that will determine the optimal daily dose distribution of NR. The NADAPT trial investigates whether NAD supplementation can delay the progression of atypical parkinsonism syndromes and will include patients from Norway, France and the UK. HYDRA is a so-called " multiarm multistage clinical trial" in which multiple drugs will be tested simultaneously. NO-ALS is a phase II study investigating whether treatment with NR and pterostilbene can slow the progression of ALS, while the extension study (NO-ALS-II) is investigating the long-term safety of this treatment. ALS-LTMV is a follow-up study that will examine the effect long-term mechanical ventilation has on the quality of life of patients with ALS. STRAT-PARK is an observational study with the aim of dividing PD and other parkinsonisms into subgroups according to underlying causes, so that tailored treatment can be developed and tested. STRAT-COG and STRAT-ALS are similar observational studies with the aim of implementing personalized medicine for Alzheimer's disease and ALS, respectively. In terms of systems medicine, the ParkOme project has mapped molecular profiles from 1,300 brains from patients with PD and other neurodegenerative diseases, and we have identified a new subtype of PD, expected to be published during 2023/2024. Work to develop clinical biomarkers is ongoing. Several cell models have been developed and are being used to screen and discover new treatments in the PARKdrug project. We are also well underway with our in silico drug screening, the DRONE project, harnessing the national Norwegian registries.

Central Nervous System (CNS) diseases affect one in three people during their lifetime and are leading causes of death and disability. Despite more than two centuries of scientific endeavor, minor advances have been gained in understanding and treating most CNS diseases; consequently, patients confront a future of progressive disability and premature death with treatments that are mostly symptomatic. Since demographic studies show that patient numbers will continue to grow, our failure to make any significant impact means that CNS diseases are now the major challenge to health care provision. Our proposed Center for Clinical Research (FKB) will integrate a centralized national hub enabling and supervising clinical trials in neurology and innovative Systems Medicine approaches, to addresses the unmet needs of patients with the most common and debilitating CNS diseases in a systematic and all-encompassing fashion. Our groundbreaking concept comprises four highly integrated and complementary activities: 1) A multidisciplinary Neurological Clinical Trial Unit (NTCU) will enable nationwide access to cutting-edge clinical trials for patients with CNS disorders, investigators/researchers and the industry. 2) Patients recruited to our trials will enter a unique Systems Medicine pipeline, which will provide standardized assessment and precision stratification, followed by highly personalized experimental treatment and care interventions. 3) In parallel, our cutting-edge translational node will integrate the powerful Norwegian registries and cutting-edge networks-biology, emerging from patient samples, with innovative disease models in order to nominate novel therapeutic targets and generate the next generation of therapies. These will be fed back into the clinical node for testing in novel clinical trials. 4) Positive results will trigger our drug development and commercialization pipeline under the leadership of our expert innovation team and infrastructure at the FKB.

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FKB-Forskningssentre for klinisk behandling