North Canton

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD. Participants are adults aged 18 to 74 years with a current major depressive episode lasting between 6 weeks and 24 months. Participants will be randomly assigned to receive either azetukalner 20 mg or placebo, both taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study uses a parallel design and includes a placebo comparator. Azetukalner and placebo are administered as daily oral doses over the treatment period. During the study, participants will undergo assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S score at Week 6. Safety and tolerability are monitored from screening through 8 weeks after the final dose. The primary outcome is the change from baseline in HAMD-17 at Week 6. Total participation may last several months, including screening, treatment, and follow-up periods.

Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

Researchers are evaluating the efficacy, safety, and pharmacological effects of three different doses of KYN-5356 compared to a placebo in adults with cognitive impairment associated with schizophrenia. This Phase 2, randomized, double-blind, placebo-controlled study aims to investigate how these treatments affect cognitive function and brain activity. The study assesses pharmacokinetics and exploratory pharmacodynamics to understand how the drug behaves and impacts neurophysiological measures in the brain. Participants will be randomly assigned to one of four groups receiving either low, medium, or high doses of KYN-5356 or a placebo. Treatment involves taking oral tablets daily for 28 days while residing in the clinic. Participants are admitted three days before treatment begins and remain in the clinic for 32 days. Electrophysiological tests will be performed on a subset of participants to evaluate the drugs effect on brain function. During the study, participants will undergo frequent evaluations for efficacy, safety, and drug levels in the body. Safety assessments continue until discharge on Day 29, followed by a follow-up visit on Day 42. Researchers will measure cognitive function changes and monitor pharmacokinetic parameters such as maximum concentration and half-life. The total participation period includes the 32-day residential stay plus the follow-up visit, allowing close monitoring throughout.

Researchers are evaluating KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the effects of KarXT for treating manic episodes in adults with Bipolar-I disorder. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess KarXTs ability to reduce mania symptoms during a 3-week inpatient treatment period. The study includes participants experiencing acute manic episodes or mania with mixed features who require hospitalization. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. Before treatment, psychotropic medications must be washed out within 14 days. The study also includes screening before treatment and a safety follow-up, with the entire study lasting up to seven weeks. During the study, participants will be closely monitored with assessments including the Young Mania Rating Scale YMRS and Clinical Global Impressions-Bipolar CGI-BP to measure symptom changes. Safety evaluations and follow-up visits are part of the process, with researchers focusing on symptom improvement and safety over the study duration.

Researchers are evaluating the effectiveness and safety of SPT-300 GlyphAllo, a drug being studied for adults with major depressive disorder MDD, including those with or without anxious distress. This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess how well SPT-300 works and how well participants tolerate it. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. The study compares these two groups to understand the impact of SPT-300 as a monotherapy treatment for MDD. During the study, participants will be assessed for changes in depression severity using the Hamilton Depression Rating Scale-17 HAM-D-17 from the start to day 42 of treatment. Additional evaluations include clinical global impression severity scores. The trial includes monitoring for safety, tolerability, and other health measures throughout the 42-day treatment period.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.