Lafayette

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 compared to a placebo in treating psychosis associated with Alzheimer's disease. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients aged 55 and older who meet specific clinical criteria for Alzheimer's disease and psychosis. The study aims to assess changes in psychosis symptoms using the BEHAVE-AD psychosis subscale score after 6 weeks of treatment. Participants will be randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is administered as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study includes three periods: up to 4 weeks of screening to determine eligibility, a 6-week double-blind treatment phase where participants receive their assigned medication, and a 30-day safety follow-up after the last dose to monitor any adverse effects. During the study, participants will undergo assessments to confirm Alzheimer's disease diagnosis and psychosis presence, including biomarker tests, clinical rating scales, and cognitive evaluations. Caregivers will be involved as designated support persons. Researchers will monitor symptom changes, safety, and tolerability throughout the treatment and follow-up periods. The primary outcome is the psychosis subscale score measured at week 6, with safety follow-up visits approximately 30 days after treatment ends.

Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder (MDD) who have responded to treatment. This Phase 4, randomized, double-blind, active-controlled, multi-center study focuses on individuals diagnosed with MDD without psychotic features and experiencing a current major depressive episode lasting at least 4 weeks. Participants will first receive open-label AXS-05 for up to 10 weeks, during which their response and remission will be monitored. Those who meet the criteria for response and remission will then be randomly assigned to continue treatment with either AXS-05 or switch to bupropion tablets (105 mg) in a double-blind phase lasting up to 26 weeks or until relapse occurs. Throughout the study, researchers will monitor the time from randomization to relapse of depressive symptoms. Participants will undergo regular evaluations to assess their mental health status and adherence to treatment. The total participation duration includes the initial 10-week open-label period followed by up to 26 weeks in the double-blind phase, with ongoing monitoring for relapse and safety.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are evaluating the effectiveness of ALTO-300 compared to a placebo when added to an antidepressant treatment in adults with moderate to severe major depressive disorder (MDD). This Phase 2 study aims to identify differences in how well ALTO-300 works based on patient characteristics. The main goal is to measure changes in depression symptoms over six weeks using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive either ALTO-300 capsules or placebo capsules once daily while continuing their current antidepressant, which must be a single SSRI, SNRI, or bupropion taken for at least six weeks without recent dose changes. The study includes a randomized, double-blind phase where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label extension phase after the initial treatment period. During the study, participants will undergo regular assessments to monitor their depression symptoms and overall health. Researchers will track changes in MADRS scores up to week 6 to evaluate treatment effects. Participants must comply with all study procedures, and safety will be closely monitored throughout the trial. The study includes adults aged 18 to 70 years who meet the specific inclusion criteria and do not have any exclusion conditions.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.