Basalt

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.