Imperial

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

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 evaluating the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analog, as an additional treatment for adults with Major Depressive Disorder (MDD). This Phase III, multi-center, double-blind, randomized controlled study compares two active doses of CYB003 against a placebo in patients experiencing moderate to severe depression who have not adequately responded to stable antidepressant treatment. Participants will receive either one of two doses of CYB003 or a placebo, along with manualized psychological support provided by a facilitator. The study includes a screening period, a dosing period, and follow-up assessments. The psychological support sessions are standardized to assist participants during the trial. During the study, participants will be assessed using the Montgomery-Asberg Depression Scale (MADRS) at multiple time points including screening, baseline, and several days during treatment up to the trial's end at Day 84. Researchers will monitor symptoms of depression, safety, and tolerability throughout the trial. Participants will also undergo various evaluations to ensure adherence and safety during the study period, which spans approximately 12 weeks from screening through the final assessment.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Major depressive disorder (MDD) is a common and serious mood disorder causing persistent sadness and loss of interest, along with emotional and physical symptoms like irritability, tiredness, and changes in appetite. This trial investigates the effects of oral Icalcaprant, an experimental drug, on adults currently experiencing a major depressive episode. The study aims to assess changes in disease activity and monitor adverse events over the treatment period. Participants will be randomly assigned to one of three groups, with about one-third receiving a placebo. Those in the treatment arms will take oral capsules of Icalcaprant once daily for six weeks. After the treatment period, there will be a 30-day safety follow-up to monitor any ongoing effects or side effects. During the study, participants will visit the hospital or clinic regularly for medical assessments, blood tests, side effect monitoring, and to complete questionnaires. Researchers will evaluate changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and track the number of participants experiencing adverse events. The total participation duration includes the six-week treatment and the 30-day follow-up.

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This Phase 2 study focuses on patients who are also taking mood stabilizers and/or atypical antipsychotic medications. The study aims to understand differences in efficacy related to patient characteristics, while also assessing safety and tolerability. Participants will receive either ALTO-100 at a dose of 40 mg twice daily or a matching placebo tablet twice daily during the Double-Blind period. Following this, there will be an open-label treatment phase to further evaluate safety, tolerability, and effectiveness. All treatments are given alongside the patient’s existing mood stabilizer and/or atypical antipsychotic therapy. Throughout the study, participants will be regularly assessed for changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from Day 1 through Week 6. Researchers will monitor safety and tolerability during both the double-blind and open-label phases. The study involves ongoing compliance with assessments and procedures to track treatment effects and participant well-being.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-4021586 in adults aged 40 to 85 years with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). This Phase 2 dose-finding study focuses on participants who have NYHA functional class II or III heart failure and a left ventricular ejection fraction (LVEF) of 60% or higher. The study aims to gather important data on the drug's effects and safety profile in this specific heart condition. Participants will receive either oral CK-4021586 at doses of 150 mg, 300 mg, 450 mg, or 600 mg, or a matching placebo. Stable doses of background medications such as beta-blockers, ACE inhibitors, ARBs, or ARNIs are required before the study, as well as stable use of GLP-1 agonists if applicable. The study is randomized, double-blind, and placebo-controlled, ensuring rigorous comparison between the investigational drug and placebo groups. During the 12-week study period, participants will be monitored for early drug discontinuation, heart function changes indicated by LVEF falling below 40%, and the occurrence of adverse events. Evaluations include echocardiography, laboratory tests for NT-proBNP levels, and ongoing safety assessments. This careful monitoring helps researchers understand the treatment's safety and tolerability in people with HFpEF over the study duration.

Researchers are evaluating the efficacy and safety of SPN-812 (viloxazine extended release) in children aged 4 to 5 years who have Attention-Deficit/Hyperactivity Disorder (ADHD). This Phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to compare SPN-812 with a placebo in this preschool-age population to better understand its effects on ADHD symptoms. Participants will be randomly assigned to receive either 100 mg of SPN-812 or a placebo once daily for 6 weeks. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. The total study duration is up to 10 weeks, including screening and treatment phases. The study uses a fixed dose and parallel-group design, meaning participants receive one treatment throughout the study. During the study, children will be assessed for changes in ADHD symptoms using a specific rating scale from the start of treatment through Week 6. Researchers will monitor safety and tolerability throughout the trial. Parents or guardians will provide consent and participate in assessments to track symptom changes and treatment effects. The study includes regular evaluations to measure ADHD symptom severity and overall clinical impression.

Researchers are evaluating lumateperone in a multicenter, randomized, double-blind, placebo-controlled phase 3 study for children aged 5 to 17 years with irritability associated with Autism Spectrum Disorder (ASD). The diagnosis of ASD is based on DSM-5-TR criteria and confirmed using the K-SADS-PL assessment. The study focuses on measuring irritability symptoms in this pediatric population. The study has three phases: a screening period up to 14 days to check eligibility, a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose. Treatments are taken orally once daily during the treatment phase. Participants and their caregivers will attend clinic visits for assessments including the Aberrant Behavior Checklist - Irritability subscale measured at week 6 to evaluate treatment effects. Safety monitoring occurs during treatment and follow-up. Caregivers must provide consent, and children may provide assent when appropriate. The total participation duration includes screening, 6 weeks of treatment, and one week of safety follow-up.

This study is designed to identify individuals who may be eligible for future Roche clinical trials focused on Alzheimer's disease. It serves as a pre-screening step to evaluate participants based on biomarker status and cognitive performance. The study targets adults aged 50 to 90 years who have experienced memory concerns recently, with or without a diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease. Participants do not receive any intervention during this study. Instead, they will have their blood drawn to measure the concentration of a biomarker called pTau217 and will undergo a cognitive assessment using the ISLT (International Shopping List Test) on the first day of participation. This process helps researchers determine potential eligibility for more extensive Alzheimer's disease trials. During the study, participants will be evaluated for memory concerns and cognitive function through blood tests and cognitive scoring. Researchers will monitor biomarker levels and cognitive scores on the first day to help assess trial eligibility. The study includes safety assessments to ensure participants can safely complete these procedures, with participation lasting for the duration of the pre-screening evaluations.