Warrington

Researchers are evaluating the safety, tolerability, immune response, and pharmacodynamic effects of ACI-24.060 in people with prodromal Alzheimers disease and adults with Down syndrome who do not have dementia. This phase 1b2 study is divided into two parts Part 1 focuses on subjects with prodromal Alzheimers disease and includes subparts 1a and 1b, while Part 2 involves participants with Down syndrome. The study aims to better understand how ACI-24.060 affects these populations by comparing different doses and placebo over time. Participants receive various doses of ACI-24.060 or placebo at scheduled times over periods of 48 to 74 weeks depending on their group. In Part 1, those with prodromal Alzheimers disease are assigned to receive placebo or one of several doses of ACI-24.060, some with an additional adjuvant, over 48 to 74 weeks. Part 2 involves adults with Down syndrome who receive placebo or different doses of ACI-24.060 over 74 weeks, with options for dose adjustments based on prior testing in Part 1. The study is randomized and double-blinded to compare responses across groups. During the study, participants undergo safety monitoring including physical and neurological exams, MRI scans, and assessments of suicidal thoughts or behavior using the Columbia-Suicide Severity Rating Scale. Blood samples are taken to measure antibody levels against beta-amyloid. Researchers also evaluate cognitive and clinical measures relevant to Alzheimers disease and Down syndrome. The study lasts up to 100 weeks including screening and follow-up, with careful tracking of side effects and immune responses to understand the treatments effects over time.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy TSNB in patients with breast cancer who have limited nodal disease and are undergoing primary surgery. The study focuses on patients with T1 or T2 tumors and biopsy-confirmed nodal metastases with up to two abnormal nodes on axillary ultrasound. The goal is to audit surgical outcomes of TSNB and compare them with outcomes from sentinel node biopsy and targeted axillary dissection after chemotherapy, assessing arm lymphoedema and disease progression over time. The intervention involves performing TSNB using either a dual- or single-tracer technique in line with protocols from the ongoing ATNEC trial. The marked biopsy-positive node and at least three nodes are removed during surgery. Node marking techniques may include clips, black dye, magnetic seeds, or reflectors, with the timing of marking either at biopsy or a separate visit. Axillary treatment after TSNB is determined by local multidisciplinary teams based on findings. Participants will be monitored for up to 60 months, with regular assessments including histology to identify nodal macrometastases, identification rates of the marked node, false negative rates of TSNB, and arm lymphoedema. Secondary outcomes include rates of axillary, regional, and local recurrence, disease-free survival, and overall survival. This long-term follow-up will help benchmark TSNB outcomes against previous trials and provide data on surgical morbidity and disease control.

This clinical trial is designed to evaluate the Bridging Technique for treating nasolabial folds, commonly known as smile lines, in adults aged 30 to 65 years. The study aims to determine whether this new method, which uses very small amounts of hyaluronic acid HA dermal filler placed in thin horizontal threads under the folds, can safely improve their appearance and satisfy patients. The Bridging Technique was developed to provide natural-looking results with less product and reduced risk compared to traditional filler methods. Participants will receive a single treatment with AILEENE Vol. 2 HA dermal filler applied using the Bridging Technique to both nasolabial folds. The total filler used will not exceed 1.0 ml across both sides. An optional top-up treatment may be given at Week 2 or Week 4 if needed, using only the remaining filler allowance and a new sterile syringe. Follow-up visits include a virtual safety check at Week 2 and in-person evaluations at Week 4, Month 3, and Month 6. During the study, standardized photographs will be taken at baseline, Week 4, Month 3, and Month 6 to assess changes in fold severity, with independent reviewers unaware of the visit order. Participants will complete questionnaires about their satisfaction and experience. The primary outcome is the change in nasolabial fold severity, and secondary outcomes include overall aesthetic improvement. The study lasts six months, with no cost to participants and voluntary involvement.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.