Maitland

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are conducting an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the effectiveness and safety of PET imaging using [18F]PI-2620 for detecting tau protein buildup in people with Alzheimer's disease and control subjects. The study compares PET imaging results during life with brain tissue analysis obtained after death through autopsy, aiming to improve diagnosis of tau-related brain changes. Participants will receive an intravenous injection of the radioligand [18F]PI-2620 at a dose of 185 MBq 20%. The PET imaging will be performed to visualize tau deposits in the brain. This study focuses on assessing the diagnostic accuracy of this imaging method by comparing it to post-mortem histopathology findings. Throughout the study, participants will undergo PET scans and assessments to determine the presence and extent of tau pathology. The primary outcome measure is the ability of visual assessment of [18F]PI-2620 PET images to correctly distinguish tau neurofibrillary pathology associated with Alzheimer's disease, confirmed at autopsy within about one year. Safety and tolerability during imaging procedures will also be monitored, with a total participation period depending on the timing of brain autopsy after death.

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP). This study is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain. Participants have diabetic peripheral neuropathy mainly affecting their lower limbs and have had this condition for at least six months. The study compares oral LY4065967 to a placebo, with participants randomly assigned to either group. The trial is a Phase 2, randomized, placebo-controlled clinical trial. Treatments are given by mouth, and participants continue their usual diabetes care with stable treatment for at least 90 days before screening. During the study, researchers monitor changes in average pain intensity using a numeric rating scale from baseline to week 8. Participants undergo assessments including blood sugar control (HbA1c), body mass index measurement, and safety monitoring for heart and vitamin B12 status. The trial is designed for adults aged 18 years and older and includes close observation to ensure participant safety throughout the study period.

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 evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

Researchers are evaluating the safety and potential benefits of VHB937 in people aged 50 to 85 years with early Alzheimer's disease, including those diagnosed with Mild Cognitive Impairment due to Alzheimer's or mild Alzheimer's disease. This Phase II, multicenter, randomized, double-blind, placebo-controlled study aims to assess how VHB937 affects memory, thinking abilities, daily activities, and brain changes, while also studying how the body processes and responds to the treatment. The study includes an initial 72-week double-blind phase followed by an extension period. Participants will receive either VHB937 solution for infusion or a placebo solution through infusion during the 72-week double-blind phase. The study compares these two groups to evaluate the effects and safety of VHB937 in early Alzheimer's disease. After the double-blind phase, participants may continue in an extension period for further observation. Treatment involves regular infusions under controlled conditions throughout the study. During the study, participants and their study partners will attend visits for assessments including memory and cognitive tests, evaluations of daily functioning, brain imaging, and biomarker analysis from cerebrospinal fluid or PET scans. Researchers will monitor safety, record any side effects, and track changes using the Clinical Dementia Rating scale (CDR) over 72 weeks. The study requires a reliable partner to accompany participants to visits, and overall participation includes monitoring during treatment and the extension phase to thoroughly assess VHB937's effects and safety.

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 safety of LY3954068 in people with early symptomatic Alzheimer's Disease (AD). This Phase 1 study aims to understand how LY3954068 behaves in the body and its effects on markers of AD. Participants will be adults aged 50 to 85 years with gradual memory decline and confirmed tau pathology shown by a special PET scan. The study has two parts: Part A involves a single dose of LY3954068 or placebo injected into the spinal fluid, while Part B involves two doses given the same way. There is also an optional bridging period where participants may receive LY3954068. Another drug, Flortaucipir F18, will be given intravenously before a PET scan to detect tau protein in the brain. Participants will be involved for up to about 45 weeks in Part A or up to about 100 weeks in Part B, including screening. The study includes regular assessments such as cognitive tests, PET scans, safety monitoring, and tracking any side effects related to the study drug. Researchers will measure the number of participants experiencing adverse events and how the drug is tolerated over time.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are evaluating the effects of ALN-APP on the progression of cerebral amyloid angiopathy (CAA), a condition affecting blood vessels in the brain. This phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in adults with sporadic CAA and Dutch-type CAA, a genetic form of the disease. The study includes a 24-month double-blind treatment period followed by an optional 18-month open-label extension to further explore the treatment's effects. Participants receive either ALN-APP or a placebo, both administered directly into the spinal canal (intrathecally). The initial 24-month period is conducted in a double-blind manner where neither the participants nor the researchers know who receives the treatment or placebo. After this, participants may join the open-label extension phase where everyone receives ALN-APP. This design helps to monitor the drug's impact over a long period. During the study, participants will undergo brain scans using magnetic resonance imaging (MRI) to measure new microbleeds in the brain, which are a marker of disease progression. Researchers will also monitor safety and drug effects through various assessments. The total participation time, including screening, treatment, and follow-up, can last up to 50 months, allowing for thorough observation of treatment outcomes and safety.