Osterwieck

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the progression of Parkinson's disease in individuals who show early signs but have not yet developed typical symptoms. This observational, international, multi-center phase 2 study focuses on using [18F] AV-133 imaging to track changes in the brain related to Parkinson's disease over time. About 100 participants with prodromal Parkinson's disease will be recruited from up to 10 sites and followed for up to 24 months, with comprehensive assessments conducted at the start and during follow-up visits. Participants will undergo [18F] AV-133 PET imaging scans targeting the vesicular monoamine transporter at baseline, 12 months, and 24 months. These imaging assessments are combined with clinical evaluations including motor, neuropsychiatric, cognitive, and biomarker assessments following the PPMI Clinical protocol. The study aims to monitor changes in imaging and clinical markers to better understand disease progression before typical Parkinson's symptoms appear. During the study, participants will be comprehensively evaluated at baseline and follow-up visits with imaging scans and clinical assessments. Researchers will measure the mean rate of change and variability in [18F] AV-133 imaging over 24 months to track progression. Safety and overall health will be monitored, and participants will be followed annually for up to two years to gather detailed data on disease development and progression.

Researchers are studying Parkinson's disease (PD) progression by observing clinical features, digital outcomes, and biological and genetic markers in people with diagnosed PD, those at risk of developing PD, and healthy individuals. The goal is to find markers that can help track the disease's progression and improve clinical trials aimed at slowing down PD disability. This research is a broad program called the Parkinson Progression Marker Initiative (PPMI), which includes multiple protocols and initiatives to gather comprehensive data. Participants may be enrolled in different parts of the PPMI program, including clinical visits, remote monitoring, digital app use, and online activities depending on their recruitment method. The study collects various types of data over time, including imaging and biological samples, and genetic testing when applicable. Participants are grouped based on their PD status and genetic factors, and the study monitors them through repeated assessments and imaging scans, such as SPECT imaging, to confirm eligibility and track changes. During the study, participants undergo clinical exams, imaging, genetic testing, and provide biological samples. Researchers track disease progression, compare changes over time, and study clinical, imaging, and biological outcomes. The study also measures the likelihood of participants developing PD if they are at risk. Assessments continue for up to 156 months, allowing for long-term observation of PD progression and related markers. Safety and suitability for continued participation are regularly reviewed by investigators.