Independence

Researchers are studying a treatment called MK-2214 to see if it can slow certain brain changes in people with early Alzheimer's disease (AD). AD is a form of dementia that causes memory loss, difficulties with communication, and challenges in decision-making, which affect daily activities. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the safety and tolerability of MK-2214. Participants will receive either MK-2214 or a placebo through an intravenous (IV) infusion. The study is designed as a phase 2, randomized, placebo-controlled, double-blind trial with parallel groups. The treatment period lasts up to about 23 months, during which participants will receive infusions as scheduled. The placebo looks like the study treatment but contains no active drug, helping researchers understand the treatment's effects. Throughout the study, participants will be monitored for changes in tau protein levels in the brain using PET scans and for any adverse events or side effects. Researchers will track the number of participants experiencing adverse events and those who stop treatment because of them, with safety follow-up lasting up to approximately 26 months. Participants will also undergo brain imaging such as CT, PET, or MRI scans. The study involves regular assessments to measure the treatment's impact and ensure participant safety over the study duration.

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.

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.

Researchers are evaluating the efficacy and safety of ML-007C-MA in treating hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP) in men and women aged 55 to 90 years. This Phase 2 study is randomized, double-blind, and placebo-controlled, aiming to compare ML-007C-MA with placebo by measuring changes in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score over seven weeks. Participants receive ML-007C-MA at doses of either 105/1.5 mg twice daily or 210/3 mg twice daily, or placebo tablets, during the treatment period. The study is designed to assess the impact of these treatments on psychotic symptoms associated with Alzheimer's disease, specifically hallucinations and delusions. Throughout the study, participants are monitored for changes in the NPI-C H+D score from baseline to the end of treatment at seven weeks. Researchers also evaluate safety and monitor participants' overall condition. The total involvement includes assessments related to cognition, symptom severity, and adherence, ensuring comprehensive evaluation of the treatment's effects and safety profile.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

This research aims to evaluate how effective valbenazine is in improving symptoms reported by both doctors and patients in adults with tardive dyskinesia (TD). The study focuses on people who either continue to have symptoms while on a VMAT2 inhibitor or after stopping such treatment. Participants include adults diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who have had mild or greater TD for at least three months. Participants will take valbenazine capsules orally as the treatment being studied. The trial is an open-label Phase 4 study, meaning all participants receive valbenazine and both clinicians and patients will report on outcomes. It includes people who remain symptomatic while on deutetrabenazine or have stopped prior VMAT2 inhibitor treatment. The study does not mention a comparator group or placebo. During the study, researchers will measure changes in involuntary movements using the Abnormal Involuntary Movement Scale (AIMS) from the start to week 24. Participants will be assessed for both clinician- and patient-reported outcomes to understand symptom changes. Safety and symptom monitoring will occur throughout the 24-week period to observe the effects of valbenazine.

Researchers are evaluating the effects of SPT-300 (GlyphAllo), a prodrug of allopregnanolone, in adults aged 18 to 65 years who have major depressive disorder (MDD), with or without anxious distress. This Phase 2 study is randomized, double-blind, placebo-controlled, and aims to assess the efficacy, safety, and tolerability of SPT-300 as a monotherapy treatment for MDD. Participants will receive either SPT-300 or a placebo and will be monitored over a 42-day treatment period. The study compares the impact of SPT-300 to placebo on depressive symptoms and any side effects experienced. The intervention is given as a drug treatment, and participants are randomly assigned to one of the two groups. Throughout the study, researchers will measure changes in depression severity using the Hamilton Depression Rating Scale-17 (HAM-D-17) total score from the start of the treatment to day 42. Participants will be assessed for safety and tolerability, and their adherence to treatment will be monitored. The study focuses on the depressive episode lasting between 4 weeks and 18 months, with careful screening to ensure participant eligibility and safety.