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Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating orelabrutinib, a brain-penetrating BTK inhibitor, in adults with Primary Progressive Multiple Sclerosis PPMS. This phase 3, randomized, double-blind, parallel-group, multicenter study compares orelabrutinib to placebo to assess its efficacy and safety in treating PPMS. About 705 participants aged 18 to 60 years will be enrolled globally with a 21 randomization favoring orelabrutinib. Participants will receive either oral orelabrutinib or a matching placebo. Treatment will last approximately 30 to 60 months, with a minimum of 12 months on study drug. The study includes two groups one receiving orelabrutinib and the other receiving placebo, both administered orally. The trial design is intended to monitor long-term effects and progression. During the study, participants will undergo regular assessments including disability progression measured over 12 weeks and up to approximately 120 weeks. Evaluations include MRI scans to monitor lesions, timed walking and hand function tests, cognitive testing, and safety assessments such as monitoring adverse events. The study will closely follow participants for up to 5 years to understand the impact of the treatment on disease progression and safety.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are evaluating RO7268489 as an add-on therapy to ocrelizumab in adults with progressive multiple sclerosis PMS. This phase II study aims to assess the safety, pharmacokinetics, pharmacodynamics, and effectiveness of RO7268489 in people with PMS, focusing on its impact on disability progression. Eligible participants have PMS and an Expanded Disability Status Scale EDSS score between 3.0 and 6.0. Participants are randomly assigned to receive one of three doses of RO7268489 or a placebo, all given alongside ocrelizumab following a predefined regimen. After the double-blind treatment phase, eligible participants may join an open-label extension to receive RO7268489 openly. The study uses a quadruple-blind design and compares these groups over approximately 110 weeks. During the study, participants will be regularly monitored for disability progression, brain volume changes, cognitive function, walking ability, hand function, and plasma levels of RO7268489 and its metabolites. Safety is tracked through adverse events and suicidal ideation assessments over up to five years. The study involves scheduled visits for treatment administration, assessments, and monitoring to thoroughly evaluate the impact of adding RO7268489 to ocrelizumab therapy.

This research aims to identify individuals who may be eligible for interventional studies related to Alzheimers Disease by assessing specific biomarkers and cognitive performance. It is a Phase 3 screening study sponsored by Hoffmann-La Roche designed to evaluate potential participants using blood tests and cognitive assessments. The study focuses on adults aged 50 to 90 years to find candidates for further Alzheimers disease research. Participants will not receive any treatment but will undergo blood draws to measure the concentration of the biomarker pTau217. They will also complete the International Shopping List Test ISLT to assess cognitive function. This screening process helps determine eligibility for linked interventional Alzheimers disease studies by combining biomarker and cognitive data. During the study, participants will provide blood samples and perform cognitive tests at the initial visit. Researchers will measure the pTau217 levels in blood and record cognitive scores from the ISLT. The study involves no experimental treatment, focusing solely on assessment. Participation lasts until the primary completion date, with data collected on Day 1 to evaluate potential eligibility for further trials.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of a modified dosing schedule of ublituximab for adults with relapsing multiple sclerosis RMS. This phase 3b study has three parts Part A is an open-label single-arm study, Part B is a randomized, double-blind, placebo-controlled study, and Part C is an open-label single-arm study focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The primary goal is to measure changes in T1 Gadolinium-enhancing brain lesions and drug levels in the blood. Participants receive ublituximab by intravenous infusion following different dosing regimens depending on the study part. In Part A, participants initially received infusions on Day 1 of Week 1, Day 15 if applicable, and Week 24. In Part B, participants receive either 600 mg ublituximab on Week 1 Day 1 followed by placebo on Day 15 and 450 mg ublituximab at Week 24, or 150 mg ublituximab on Day 1 followed by 450 mg on Day 15 and Week 24. Part C participants receive 150 mg on Day 1, then 450 mg on Day 15 and Week 24. Enrollment in Parts A and B has closed according to protocol updates. During the study, participants undergo regular assessments including brain imaging to track T1 Gadolinium-enhancing lesions, blood tests to measure drug levels, and evaluations for infusion-related reactions. Treatment satisfaction questionnaires are collected at baseline, Week 24, and Week 48. Safety and efficacy are monitored up to 48 weeks. The total study duration covers treatment and follow-up visits, with primary outcomes measured at Week 48 to assess changes from baseline.