Gaithersburg

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Schizophrenia is a serious psychiatric disorder that affects thinking, language, perception, and the sense of self. This research aims to evaluate the safety, side effects, effects on disease symptoms, and how the investigational drug emraclidine is processed in adults with schizophrenia. The study is a Phase 2 clinical trial involving about 268 participants across approximately 32 sites in the United States. Participants are divided into two groups: Part A and Part B. In Part A, participants receive varying doses of oral emraclidine or placebo for 14 to 21 days. In Part B, participants receive oral emraclidine or placebo for up to 42 days. After completing the treatment, all participants are followed for 30 days to monitor safety and effects after stopping the drug. During the study, participants will attend regular hospital or clinic visits for medical exams, blood tests, questionnaires, and monitoring for side effects. Researchers will measure multiple outcomes including adverse events, changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS), and how the drug and its metabolites move through the body. The total participation time includes treatment and a 30-day follow-up period.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the effects of KYN-5356 on cognitive function in adults with cognitive impairment associated with schizophrenia. This Phase 2 study is randomized, double-blind, and placebo-controlled, designed to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of three different dose levels of KYN-5356 compared to placebo over 28 days. Participants are assigned to one of four groups: placebo, low dose KYN-5356, medium dose KYN-5356, or high dose KYN-5356. The study involves oral tablet administration once daily from Day 1 through Day 28. Participants are admitted to the clinic three days before treatment begins and remain in residence for 32 days. Some participants at selected sites will undergo special brain function tests to study the neurophysiological effects of KYN-5356. During the study, participants will have ongoing assessments for efficacy, safety, and drug behavior in the body. They will be discharged on Day 29 after safety checks and return for a follow-up visit on Day 42. Researchers will measure cognitive function as the primary outcome to determine the impact of the treatment over the 28-day period.

Researchers are evaluating the effectiveness of DT-101 in treating adults with Major Depressive Disorder (MDD). This Phase 2 clinical trial compares DT-101 to a placebo to understand its impact on depression symptoms and evaluates the safety and tolerability of the study drug. Participants have recurrent depression diagnosed by the latest DSM manual and are between 18 and 75 years old. Participants will receive either DT-101 or placebo in a double-blind, randomized manner. The study includes physical and neurological examinations, blood and urine sample collections, and clinical assessments to monitor ongoing suitability and gather data on the drug's effects. Blood samples will also be used to study how DT-101 is absorbed and metabolized and to explore genetic factors that may influence treatment response. During the study, participants will visit the clinic every few weeks to undergo general health checks and complete questionnaires. Researchers will measure changes in depression using the Montgomery Åsberg Depression Rating Scale (MADRS) from the start of the study to Day 42. Safety and adherence will be closely monitored throughout the trial, ensuring participant well-being and data accuracy.

Researchers are evaluating the safety and effectiveness of KarXT compared to a placebo for treating adults with Bipolar-I disorder experiencing an acute episode of mania or mania with mixed features. This Phase 3 study involves participants who require hospitalization due to their manic episode and aims to assess symptom improvement over a short-term inpatient period. The study lasts up to seven weeks, including screening, treatment, and safety follow-up. Participants will be randomly assigned to receive either KarXT or a placebo in specified doses during a three-week inpatient treatment period. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. The focus is on the change in mania symptoms measured by the Young Mania Rating Scale during the three weeks. Throughout the study, participants will be closely monitored with psychiatric evaluations and rating scales, including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Safety assessments continue during the follow-up period. The total participation time, from screening through treatment and safety monitoring, will not exceed seven weeks.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are evaluating the effects of JNJ-89495120, an investigational drug, on reducing symptoms of major depressive disorder (MDD) in adults. This Phase 2 study compares JNJ-89495120 to a placebo to assess its antidepressant effects, safety, and tolerability in participants diagnosed with recurrent MDD without psychotic features. Participants must be experiencing a current depressive episode that started before age 55 and lasts between 2 and 24 months. Participants will receive either JNJ-89495120 or a placebo as monotherapy during the study. The treatment is administered while maintaining a double-blind and randomized design to ensure unbiased results. Dosing details are not specified, but the study focuses on monitoring how well the drug works and how well participants tolerate it compared to placebo. During the study, researchers will monitor changes in depression symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to Day 5. Participants will be assessed for safety and tolerability throughout the trial. The study includes adults aged 18 to 64 with specific diagnostic criteria and treatment history, aiming to provide clear evidence on the drug's impact on depression over a short treatment period.