Pikesville

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of TP-05 in healthy adults who are at high risk of tick exposure and Lyme disease. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how TP-05 performs compared to a placebo in preventing Lyme borreliosis. The study enrolls adults aged 18 to 70 years who are overtly healthy and able to comply with study procedures. Participants will be randomly assigned to receive either a low dose or high dose of TP-05 or a matching placebo, all administered orally according to a predefined dosing schedule. The study includes a screening period, a treatment period lasting up to 24 weeks, and a safety follow-up period. During treatment, participants will be monitored closely for any adverse effects and signs of Lyme borreliosis. Throughout the study, participants will undergo safety assessments including monitoring of adverse events, clinical laboratory tests, vital signs, physical exams, and electrocardiograms. Researchers will follow participants for approximately 15 months to track safety outcomes and any tick bites or symptoms of Lyme disease. Key measures include changes from baseline in laboratory results, vital signs, and ECG parameters, ensuring thorough safety evaluation over the study course.

Researchers are evaluating the effects of ALTO-207 on adults with treatment-resistant depression (TRD). This Phase 2 trial compares ALTO-207 against a placebo to measure changes in depressive symptoms in participants who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments. The goal is to understand how well ALTO-207 works in improving depression symptoms in this group. Participants will receive either ALTO-207 twice daily or a matching placebo. This randomized, double-blind, placebo-controlled trial involves treatment over a period of up to 8 weeks, during which symptom changes will be closely monitored. The study focuses on adults aged 18 to 75 who are already on stable doses of one or two oral antidepressants. During the study, participants will be assessed for changes in their depression severity using the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline up to 8 weeks. Researchers will monitor safety and symptom changes throughout the treatment period. Participants’ adherence to the treatment and overall health will also be observed to gather comprehensive data on the study outcomes.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating LHP588 in people with mild to moderate Alzheimer's disease (AD) who have shown mental decline over the past year and have an infection with P. gingivalis, a bacterium linked to dementia development. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of LHP588 in slowing or stopping AD progression in those with confirmed P. gingivalis infection by saliva PCR testing and clinical cognitive decline. Participants must meet AD criteria by the National Institute on Aging-Alzheimer's Association and show plasma pTau217 above a set level. Participants will be randomly assigned to receive either 25 mg or 50 mg of LHP588 or a placebo once daily by mouth for 48 weeks. The treatment is taken on an empty stomach at about the same time each day, with a two-week dose increase phase for the higher dose group. Before treatment, a screening period of up to 12 weeks includes cognitive tests, saliva sampling for infection confirmation, and brain MRI to rule out other causes of dementia. After treatment, a 4-week safety follow-up monitors health status. Throughout the up to 64-week study, participants and their caregivers will visit the study center at least 20 times for assessments including medical history, physical exams, saliva and blood samples, cognitive tests like ADAS-Cog, and safety monitoring. Phone contact will occur at least once during follow-up. Researchers will measure changes from baseline in cognitive function using the ADAS-Cog11 scale at the end of treatment. Caregiver involvement is required to support participation and visits.

Researchers are conducting a Phase III, multicenter, randomized, double-blind, placebo-controlled study to examine the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults diagnosed with social anxiety disorder (SAD). The study is designed to assess the treatment's effect on acute anxiety triggered by psychosocial stress in adults aged 18 to 65 years who have significant symptoms of social anxiety. Participants will be randomly assigned in equal numbers to receive either one oral capsule of VQW-765 or a matching placebo. After taking the assigned treatment, participants will undergo a psychosocial stress test to evaluate the medication's impact on anxiety symptoms. Approximately 1 to 2 weeks following the treatment visit, participants will complete a remote safety follow-up assessment to monitor their wellbeing. Throughout the study, researchers will monitor anxiety levels using tools such as the Subjective Units of Distress Scale (SUDS) measured one day after treatment. Participants will also be assessed for safety and any side effects during the follow-up period. The total study participation involves the treatment visit with testing and the subsequent remote safety check, ensuring comprehensive evaluation of both efficacy and safety outcomes.