Kovin

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the effectiveness of NBI-1065845 compared with a placebo as an additional treatment to delay the return of depressive symptoms in people with major depressive disorder MDD. This Phase 3 study focuses on maintaining the treatment effect in participants diagnosed with recurrent moderate or severe MDD or persistent depressive disorder who have not fully responded to oral antidepressants. Participants first receive NBI-1065845 during an open-label treatment period. Then, in a randomized, double-blind phase, participants are assigned to either continue NBI-1065845 or switch to a matching placebo. The study uses oral tablets for both NBI-1065845 and placebo treatments and follows a parallel study model. Throughout the trial, participants will be monitored for relapse of depressive symptoms using the Hamilton Depression Rating Scale and other assessments. The primary outcome is the time from randomization until relapse or study end, lasting up to approximately 32 months. Participants must continue their antidepressant treatments at the same dose during the study and comply with all procedures and restrictions. Safety and adherence are closely observed by the investigators during the entire study period.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

Researchers are evaluating masupirdine, an oral tablet taken once daily, for its potential to treat agitation in people with dementia of the Alzheimers type. This phase 3, multicenter study is randomized, double-blind, and placebo-controlled, aiming to assess the drugs efficacy, safety, tolerability, and pharmacokinetics. About 375 participants aged 50 to 90 years will be enrolled worldwide. Participants will be randomly assigned to one of three groups low dose masupirdine 50 mg, high dose masupirdine 100 mg, or a matching placebo. Treatment will last 12 weeks, with dosing from Day 1 through Day 85. Screening will take place within approximately 4 weeks before randomization to confirm eligibility based on cognitive and agitation criteria. During the study, participants will be monitored using assessments like the Cohen-Mansfield Agitation Inventory to measure agitation changes from baseline to Week 12. Additional evaluations include the Modified Alzheimers Disease Cooperative Study-Clinical Global Impression of Change. Researchers will track safety and tolerability throughout. The total involvement spans the screening and 12-week treatment period, with ongoing monitoring for effects and side effects.

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 as an additional treatment for adults with generalized anxiety disorder GAD who have not responded well to their current GAD medications. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted by Intra-Cellular Therapies, Inc. Participants must meet specific diagnostic criteria for moderate to severe GAD and show inadequate response to standard treatments. The study consists of three periods a screening phase lasting up to 3 weeks to assess eligibility and allow for medication washout a 6-week double-blind treatment phase where participants are randomly assigned to receive either ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all given once daily as sublingual tablets and a 1-week safety follow-up period. Participants continue their existing GAD treatment during the study. During the trial, participants will undergo various assessments including anxiety severity ratings using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression Scale-Severity CGI-S at week 6. Safety and tolerability will be monitored throughout, with a follow-up visit after the treatment phase. Overall participation spans approximately 10 weeks including screening and follow-up.