Haugesund

This research aims to evaluate a personalized digital treatment designed for adolescents aged 15 to 18 with eating disorders. The study investigates the feasibility, preliminary clinical outcomes, and cost-effectiveness of this digital approach within a child and adolescent psychiatric outpatient setting. It uses both qualitative and quantitative methods, including semi-structured interviews, to understand the treatment's acceptability, adherence, and impact on symptoms of eating disorders. Participants will undergo a 10-week therapist-guided digital treatment program focused on reducing eating disorder symptoms and improving life-coping skills. The treatment helps adolescents gain knowledge about eating disorders, manage food and activity balance, regulate emotions, build self-esteem, and cope with social challenges. Weekly therapist contact supports participants throughout the intervention. Throughout the study, participants complete self-report questionnaires at multiple time points: before treatment, during, after the 10-week program, and at 3- and 6-month follow-ups. Measures include treatment credibility, adherence, satisfaction, eating disorder symptoms, clinical impairment, and quality of life. Researchers will also evaluate recruitment success and gather detailed patient experiences through interviews. The study aims to identify who benefits most and understand the treatment's overall utility and cost-effectiveness.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

Amyotrophic lateral sclerosis (ALS) is a serious, fast-progressing nervous system disease with an average survival of 2.5 years after diagnosis. Currently, effective treatments are limited to Riluzole. Research suggests that increasing cell access to Nicotinamide Adenine Dinucleotide (NAD) and stimulating enzymes called sirtuins may slow disease progression. This study aims to evaluate whether a combination of Nicotinamide Riboside (NR) and Pterostilbene, called EH301, can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. The NO-ALS extension study follows patients who completed the original NO-ALS trial. All participants receive the active treatment EH301, which combines Nicotinamide Riboside and Pterostilbene, as an open-label extension. This study provides patients the option for compassionate use of the supplement while assessing its effects on motor symptoms, lung function, and survival. Participants will be monitored for adverse events throughout the study, which lasts up to 1 year. Researchers will track safety, progression of motor symptoms, changes in vital capacity, and overall survival. This extension allows long-term observation of EH301's impact on ALS progression and patient well-being.

Researchers are investigating the effects of ambroxol, a Glucocerebrosidase (GCase) enhancing chaperone, on cognition, functional decline, and neuropsychiatric symptoms in individuals diagnosed with prodromal and early dementia with Lewy bodies (DLB). This Phase IIa clinical trial aims to confirm the impact of ambroxol on these outcomes compared to placebo, focusing on patients with mild cognitive impairment or early dementia stages of DLB. Participants will be randomly assigned to receive either oral ambroxol or a matching placebo. The dosing starts at 60 mg three times daily for the first week and gradually increases through five intra-participant dose escalations up to 420 mg three times daily, continuing for up to 18 months during the blinded phase. After completing the blinded phase, all participants will be offered an open-label extension of ambroxol treatment for an additional 12 months. The study includes regular hospital visits and telephone contacts to monitor treatment effects and safety. During the study, participants will undergo clinical and laboratory assessments, including cognitive tests, blood analyses, electrocardiograms, lumbar punctures, MRI, DaTSCAN, and EEG scans. The research team will monitor adverse events and treatment tolerability throughout 18 months with scheduled visits at screening, baseline, weeks 4, 8, 24, 36, 52, and months 15 and 18, along with frequent phone calls to record any side effects. Primary outcomes include changes in cognition, global function, disease progression, and neuropsychiatric symptoms. Secondary and exploratory outcomes will assess sleep disturbances, falls, parkinsonism, and potential biomarkers related to the drug effects.

Researchers are investigating the use of digital biomarkers and predictive algorithms to better understand and track disease fluctuations in patients with prodromal dementia with Lewy bodies (DLB). The study aims to improve treatment, diagnosis, and prognosis by evaluating the study drug Ambroxol in conjunction with digital health tools. This project is an extension of the ANeED study and focuses on collecting continuous symptom data and caregiver distress information through digital means. Participants will use a digital application to report medication intake and side effects. Data will be collected continuously from various digital sensors including a smartphone, smartwatch, movement sensors, an EEG/EOG/mood sensor, and a bedside sleep monitor. These devices monitor symptoms, activity, sleep disturbances, and mood over time without requiring additional inpatient clinic visits. The study drug Ambroxol is administered orally with a carefully escalating dose schedule over a period of up to 18 months. Participants and their caregivers will engage in cognitive tests via smartphone and provide health data through wearable devices. Researchers will collect and analyze continuous digital data to support diagnosis and assess medication effectiveness. Safety monitoring and adherence tracking are integral, and the total study duration includes all visits from start through the 18-month treatment period. Blood samples for genetic analysis are also collected to support the study objectives.

Researchers are evaluating whether D-serine, a modulator of the N-methyl-D-aspartate receptor (NMDAR), has therapeutic effects on Parkinson's disease (PD). This randomized, double-blind, placebo-controlled Phase 2 trial includes 100 participants diagnosed with PD within the past 5 years. The study aims to assess D-serine's impact on symptom severity using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and also investigates effects on brain dopamine transporter levels and cognitive function. Participants will receive both placebo and D-serine during different periods of the 58-week treatment phase. D-serine dosing begins with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily for the remaining intervention period. Participants' existing dopaminergic medications will be optimized before study start and maintained stable for the first 32 weeks; adjustments may be made after this time. Following the treatment phase, participants will stop study drugs and enter a 12-week washout period with a final study visit. Throughout the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sample collection, and dopamine transporter imaging using single-photon emission tomography (DaTscan). Researchers will monitor changes in clinical symptoms, brain dopamine transporter levels, and cognition, as well as safety aspects. The total study duration for each participant includes screening, 58 weeks of treatment, and 12 weeks of follow-up after stopping study drugs.

Researchers are evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Autism spectrum disorders (ASD) affect about 1% of children in Norway and cause significant social challenges and dependence on support. Parents are usually the main caregivers but often face high stress due to the demands of caring for a child with ASD, which can negatively impact their mental health and quality of life. This trial evaluates the effectiveness of a specific parenting program called the Incredible Years Autism Spectrum and Language Delay Programme (IY-ASLD) compared with a standard treatment as usual (TAU) program of clinical parent workshops, aiming to provide evidence for better parental support in ASD care. The study compares two interventions for parents of children aged 2 to 6 years diagnosed with ASD. The IY-ASLD program includes 13 weekly group sessions lasting 2 hours each, using interactive methods like video examples, discussions, and homework to teach social and communication skills tailored to the child's needs. The TAU group attends a three-day workshop focusing on communication, psychoeducation, and daily living challenges like nutrition and sleep. Both programs run alongside each other, ensuring similar timing and follow-up. Participants will be involved in questionnaires and interviews over a two-year follow-up period. Researchers will assess changes in parental stress, competence, and quality of life, as well as child functioning and service use. The main outcome measured is the change in parental stress at 6, 18, and 30 months. Qualitative interviews will explore parents' experiences to understand what aspects of the programs work best for different families. The study also monitors safety and aims to inform future care for families with children with ASD.

Researchers are evaluating the Invest in Play (iiP) parent program to see if it can reduce problem behaviors in children and improve parenting practices. The study focuses on families with children who show challenging behaviors, aiming to find out if the iiP program leads to better outcomes for both children and parents by comparing it to a control group. This is a behavioral intervention study involving children with problem behavior and attention deficit and disruptive behavior disorders. The intervention involves a 12-session group-based parent program called Invest in Play (iiP), led by two trained group leaders. Families are randomly assigned to either the iiP program group or a control group. The program is designed to support parents in managing their children's behaviors through structured group sessions. Participants will complete surveys before starting the program and after finishing it to measure changes in children's behaviors. The main outcome measured is the change in the Eyberg Child Behavior Inventory (ECBI) score from the beginning to the end of the 12-week treatment period. The study tracks these changes to assess if the iiP program effectively reduces problem behaviors in children.

Researchers are investigating the effects of fasudil, a ROCK inhibitor, in people with early Alzheimer's disease (AD) through a placebo-controlled, double-blind Phase 2 clinical trial. The study aims to determine whether fasudil improves working memory over 12 months compared to placebo, and to assess its impact on other cognitive functions, brain metabolism measured by FDG-PET scans, and various clinical biomarkers in individuals with early AD. Participants must have mild cognitive impairment or mild dementia due to AD and show significant changes on AD biomarkers. Participants are randomized into two groups to receive either fasudil or placebo. The treatment starts with a 2-week titration period at 60 mg daily, followed by an escalation to a maintenance dose of 120 mg daily for up to 50 weeks. Clinic visits for efficacy and safety assessments occur every 2 weeks during the first month and monthly thereafter. The study includes three cohorts with increasing participant numbers and involves monitoring by a Data and Safety Monitoring Board for safety and pharmacokinetic data review. During the study, participants undergo cognitive testing every three months for up to one year, including the FLAME computer-based working memory composite and other cognitive assessments. Brain metabolism changes are evaluated with FDG-PET scans at baseline and after 12 months. Additional clinical measures, biomarker analyses, safety evaluations, and quality of life assessments are conducted throughout the trial. The total participation period lasts approximately 12 months, with regular monitoring to ensure safety and collect study data.