Imperial

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying the effects of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for adults with Major Depressive Disorder MDD. This Phase III study aims to evaluate the safety, tolerability, and effectiveness of two different doses of CYB003 alongside participants current antidepressant medications and psychological support. Participants will be randomly assigned to one of three groups one receiving 8 mg of CYB003, another receiving 16 mg of CYB003, or a placebo group. Each participant will undergo two dosing sessions about three weeks apart while continuing their usual antidepressant treatment and receiving manualized psychological support from a facilitator. Non-responders in the placebo group may have the chance to receive CYB003 in an extension trial. During the study, participants will complete several assessments including the Montgomery-Asberg Depression Scale MADRS, Beck Depression Inventory-II BDI-II, Clinical Global Impression Scale CGI-S, Generalized Anxiety Disorder 7-Item Scale GAD-7, and Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q-SF. These evaluations occur at multiple timepoints from screening through the end of the trial. Safety and tolerability will be closely monitored throughout the study, with the total duration lasting approximately 12 weeks from baseline to study end.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.

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 study aims to understand how patient characteristics influence the drugs effectiveness when added to a mood stabilizer andor atypical antipsychotic treatment. The study also assesses safety, tolerability, and efficacy during an open-label treatment phase following the initial blinded period. Participants will be randomly assigned to receive either ALTO-100 40 mg tablets or a matching placebo twice daily for six weeks during the double-blind phase. Those who qualify and continue into the open-label phase will receive ALTO-100 40 mg tablets twice daily for up to seven additional weeks. The study involves careful monitoring of depressive symptoms using standardized rating scales and safety evaluations throughout both study periods. During the trial, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale MADRS, Patient Health Questionnaire PHQ-9, and Clinician Global Impression Scale-severity CGI-S. Safety monitoring covers adverse events, vital signs like heart rate and blood pressure, weight, and suicidality using the CHRT-SR12 scale. The total study duration for each participant can extend up to 13 weeks, with close follow-up to evaluate treatment effects and safety.

Researchers are evaluating CK-4021586 in adults aged 40 to 85 years who have symptomatic heart failure with preserved ejection fraction HFpEF. This Phase 2 study aims to find the best dose while assessing safety, tolerability, and how the drug affects heart function and related markers. The study is sponsored by Cytokinetics and involves randomized and blinded comparisons with placebo. Participants may receive various daily doses of CK-4021586150 mg, 300 mg, 450 mg, or 600 mgguided by echocardiography assessments, or a matching placebo, for a total of 12 weeks. The dosing is arranged in cohorts, and participants receive either the drug or placebo during the treatment period while their heart function is closely monitored. During the study, participants will have regular evaluations including echocardiography to measure left ventricular ejection fraction LVEF, blood tests to check NT-proBNP levels, and safety assessments to track adverse events and early drug discontinuation. These measurements occur at baseline, week 6, and week 12. The study monitors pharmacokinetics and pharmacodynamics of CK-4021586 and will follow participants for the full 12-week treatment duration.

Researchers are studying the effects of solriamfetol in adults aged 18 to 65 years who have major depressive disorder MDD accompanied by excessive daytime sleepiness EDS. This Phase 3 trial is designed to evaluate the treatments ability to maintain clinical response and prevent relapse of depressive symptoms during a randomized withdrawal period. The study includes multiple centers and uses a double-blind, placebo-controlled, randomized withdrawal design to provide reliable results. Participants first enter a screening phase, followed by an open-label treatment period where all receive solriamfetol tablets once daily. Those who respond clinically are then randomized to either continue solriamfetol or switch to placebo in a double-blind manner. This randomized withdrawal period continues until relapse of depressive symptoms or up to 24 weeks. The study concludes with a follow-up period to monitor outcomes. Throughout the trial, participants will be closely monitored using clinical assessments to evaluate the time to relapse of depressive symptoms. Study staff will assess adherence and response during the open-label and randomized phases. The total participation duration varies depending on individual response and relapse, with the primary outcome measured up to 24 weeks after randomization. The trial aims to provide detailed information on the treatments role in managing depression with excessive sleepiness.

Researchers are evaluating the efficacy and safety of SPN-812 viloxazine extended release in children aged 4 to 5 years with Attention-DeficitHyperactivity Disorder ADHD. This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-DeficitHyperactivity Disorder Rating Scale, 4th Edition, Preschool Version ADHD-RS-IV-P and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.

This research aims to identify individuals who may be eligible for interventional studies related to Alzheimers Disease by assessing specific biomarkers and cognitive performance. It is a Phase 3 screening study sponsored by Hoffmann-La Roche designed to evaluate potential participants using blood tests and cognitive assessments. The study focuses on adults aged 50 to 90 years to find candidates for further Alzheimers disease research. Participants will not receive any treatment but will undergo blood draws to measure the concentration of the biomarker pTau217. They will also complete the International Shopping List Test ISLT to assess cognitive function. This screening process helps determine eligibility for linked interventional Alzheimers disease studies by combining biomarker and cognitive data. During the study, participants will provide blood samples and perform cognitive tests at the initial visit. Researchers will measure the pTau217 levels in blood and record cognitive scores from the ISLT. The study involves no experimental treatment, focusing solely on assessment. Participation lasts until the primary completion date, with data collected on Day 1 to evaluate potential eligibility for further trials.

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.

This research aims to evaluate the safety and effectiveness of ABBV-932 when added to antidepressant therapies ADTs in adults with generalized anxiety disorder GAD who have not adequately responded to ADTs alone. The study is a Phase 2, randomized, double-blind, placebo-controlled trial involving approximately 315 adult participants across about 50 sites in the United States and Puerto Rico. ABBV-932 is an investigational oral drug developed as an adjunct treatment for GAD. Participants will be randomly assigned to one of three groups two different doses of ABBV-932 added to their prescribed ADTs, or a placebo added to their ADTs. The treatment period lasts for 6 weeks, during which participants will take oral capsules of ABBV-932 or placebo alongside their ongoing antidepressant treatment. Following the treatment, there is a 4-week follow-up period to monitor outcomes and safety. During the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, side effect monitoring, and questionnaires will be conducted to evaluate the treatments impact. The main outcomes measured include the number of adverse events and changes in anxiety levels assessed by the Hamilton Anxiety Scale. Additional assessments include worry questionnaires and depression rating scales. The total participation time is approximately 10 weeks, covering treatment and follow-up.