Haugesund

Researchers are evaluating the feasibility and preliminary clinical outcomes of a personalized digital treatment designed for adolescents with eating disorders aged 15 to 18 years. The study aims to understand who benefits from this digital approach, how acceptable and credible it is to participants, and the cost-effectiveness of delivering such treatment in routine child and adolescent psychiatric outpatient care. The intervention includes a therapist-guided digital program consisting of 8 modules delivered over 10 weeks, with weekly therapist contact. Participants will complete self-report questionnaires before, during, and after the treatment, as well as at 3- and 6-month follow-ups. The study also involves semi-structured phone interviews with some participants to explore their experiences with the treatment. Participants will be asked to complete various validated questionnaires assessing eating disorder symptoms, general psychopathology, quality of life, and treatment satisfaction throughout the study period. Adherence to the treatment and participant experiences will be monitored, along with health and social outcomes such as school attendance and emotional regulation. Data collection occurs online, and the total follow-up extends to six months after treatment completion.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Researchers are evaluating the effects of ambroxol, a drug that enhances Glucocerebrosidase GCase, on cognition, functional decline, and neuropsychiatric symptoms in people diagnosed with prodromal and early dementia with Lewy bodies DLB. This phase IIa study aims to confirm how ambroxol influences these areas compared to a placebo, with attention to disease progression and biomarkers related to DLB. Participants will be randomly assigned to take either oral ambroxol or a matching placebo. The medication dose escalates over the first month, starting at 60 mg three times daily and increasing to 420 mg three times daily, continuing up to 550 days. The study includes a blinded phase lasting 18 months, followed by an open extension offering ambroxol to all participants for an additional year. Throughout the study, participants will attend eight hospital visits and receive sixteen telephone calls to monitor safety, side effects, and treatment adherence. Various assessments will be conducted, including cognitive tests, neuropsychiatric evaluations, blood tests, MRI, DaTSCAN imaging, ECG, EEG, and lumbar punctures. The primary outcomes focus on cognitive changes, global function, disease stage, and neuropsychiatric symptoms, with secondary and exploratory outcomes addressing sleep, motor symptoms, falls, and biomarker impacts.

Researchers are studying dementia with Lewy bodies DLB, focusing on developing digital tools to monitor disease symptoms that can vary daily and even within a day. The study aims to improve diagnosis, treatment, and prognosis by capturing these fluctuations using digital biomarkers. It is an observational extension of the ANeED study, which evaluates the use of the study drug Ambroxol in patients with early or mild DLB. Participants include patients taking oral Ambroxol or a placebo with gradually increasing doses from day 1 through day 550, along with their primary caregivers. The study uses a digital application, smartwatches, sleep monitors, movement sensors, and EEGEOGmood sensors to continuously collect health data and monitor symptoms remotely at home. Caregivers also report their distress levels as part of the study. Participants will complete cognitive tests on a smartphone and wear various sensors for one week to record activity, sleep, and mood. Data on medication intake and side effects are logged via the digital app. The main outcome measured is the use of digital biomarkers to support diagnosis and assess medication effects over an 18-month treatment period. There are no additional clinic visits beyond those in the original ANeED study, and all monitoring is done in the participants home environment.

Researchers are evaluating whether D-serine, a co-agonist of the N-methyl-D-aspartate receptor NMDAR, can improve symptoms and slow progression in Parkinsons disease PD. This randomized, double-blind, placebo-controlled trial involves 100 participants diagnosed with PD within the past 5 years. The study aims to measure changes in clinical severity using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS, along with dopaminergic brain activity and cognitive function. Participants will be randomly assigned to two groups that receive both D-serine and placebo during different study periods over 58 weeks. D-serine dosing starts with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily thereafter, while placebo capsules are given similarly. After the intervention phase, a 12-week washout period will follow where the study drug is stopped, with a final visit 12 weeks after discontinuation. During the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sampling, and dopamine transporter imaging via SPECT scans. Researchers will closely monitor motor and non-motor symptoms, brain dopamine function, and cognitive changes. The trial includes a screening and treatment optimization phase before randomization to ensure stable Parkinsons treatment. This study may provide important insights into D-serines potential effects on Parkinsons disease progression.

Researchers are evaluating parenting programs for children aged 2 to 6 years with autism spectrum disorder ASD, a condition that affects social skills and independence. The study compares a specific manualized parent program called Incredible Years Autism Spectrum and Language Delay Programme IY-ASLD with a standard treatment as usual TAU program consisting of clinical parent workshops. The goal is to reduce parental stress, improve parenting skills and self-confidence, and enhance quality of life for both parents and children. The study also explores long-term child functioning and health service use. The study involves two groups one receives the IY-ASLD program, which includes 13 weekly 2-hour group sessions with video examples, discussions, and homework to support parents in managing their childs social and communication needs. The other group attends the TAU program, a three-day workshop focusing on communication and daily living challenges. Both programs run during the same semester, with multiple groups conducted across three clinics to recruit enough families for the randomized controlled trial. Participants will be involved for up to 30 months with assessments at 6, 18, and 30 months measuring parental stress using the Parenting Stress Index, child quality of life, parental competence, daily child functioning, and health service use. The study includes qualitative interviews to understand parents experiences and identify which programs work best for different families. Questionnaires and structured evaluations will be used to collect data, ensuring careful monitoring and follow-up throughout the study duration.

Researchers are evaluating the Invest in Play iiP program to see if it can reduce problem behaviors in children aged 6 to 12 and improve parenting practices. The study compares families participating in the iiP program with those receiving usual care. Participants are randomly assigned to either group to assess the programs impact on child behavior and parenting. The iiP program involves 12 weekly group sessions led by two trained leaders, designed for parents of children with behavioral challenges. The control group continues with their usual care, which may include further assessments, school meetings, individual care, or psychoeducation. The study period for the intervention lasts 12 weeks. Participants complete surveys before and after the program to measure changes in child behaviors using the Eyberg Child Behavior Inventory and other tools. Researchers also assess social competence, quality of life, family adjustment, parental stress, cognition, and emotion regulation. The main outcome is the change in child behavior scores from baseline to the end of the 12-week treatment period.

Researchers are evaluating fasudil, a ROCK-inhibitor, in people with early Alzheimers disease AD to see if it improves working memory compared to placebo over 12 months. This Phase 2, placebo-controlled, double-blind trial aims to assess the effects of fasudil on cognitive functions, brain metabolism using FDG-PET scans, and other clinical functions and biomarkers in individuals with early AD. Fasudil has shown neuroprotective effects in animal models and is approved in some countries for other uses. The study involves two groups one receiving fasudil and the other receiving a matching placebo. Participants start with a 2-week titration period at 60 mg daily, then increase to a maintenance dose of 120 mg daily for up to 50 weeks. Visits for safety and efficacy evaluations occur every two weeks for the first month and monthly thereafter. The trial enrolls up to 200 people in three cohorts of increasing size, with random assignment to fasudil or placebo. Participants attend regular clinic visits for cognitive testing, FDG-PET scans, and biomarker collection including blood and cerebrospinal fluid samples. Safety is monitored through monthly assessments of vital signs, lab tests, ECGs, and suicide risk scales. The main outcomes include changes in working memory scores and brain metabolism after 12 months. The trial includes ongoing safety review by a Data and Safety Monitoring Board and lasts about one year per participant.

This research aims to explore the genetic causes related to the development of Amyotrophic Lateral Sclerosis ALS in Norway. The study focuses on individuals diagnosed with probable or definite ALS according to the El-Escorial criteria. Understanding genetic factors may help in better characterizing the disease and its risk factors over time. Participants diagnosed with ALS will be followed through the Norwegian health-care system. After giving informed consent, they will complete a brief questionnaire about their family history and provide a blood sample. These samples, along with clinical information and consent forms, are sent to the Department of Medical Genetics at Telemark Hospital Trust for ongoing genetic analysis throughout the recruitment period. Participants may choose to receive their genetic results as part of a diagnostic process. During the study, participants will be involved in providing blood samples and completing questionnaires. Researchers will analyze genetic data to identify gene frequency, new ALS genes, and genetic risk factors between 2020 and 2030. The study involves observation only, with no additional treatments. Participation includes genetic testing and data collection to better understand ALS genetics, with the study continuing until 2035.