West Long Branch

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 assessing the effectiveness and safety of current standard treatments in people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not adequately responded to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with active disease despite treatment, aiming to better understand outcomes in this group. Participants receive standard care treatments based on product labels, which include glucocorticoids and immunosuppressants, with at least one biologic therapy used for a minimum of three months. The study includes those with lupus nephritis confirmed by recent kidney biopsy showing specific active disease features. Treatment follows usual clinical practice without experimental therapies. During the study, participants will be monitored for disease remission using established lupus criteria at six months. Researchers will collect routine clinical data and track safety and response to treatments. The study requires participants to be at least 16 years old and to provide informed consent. Pregnant women and those involved in other experimental drug trials are excluded. The study involves ongoing clinical follow-up to evaluate outcomes over time.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels at 24 weeks in adults with tophaceous gout. This condition involves the presence of measurable tophi, or deposits of uric acid crystals, in joints such as hands, wrists, feet, or ankles. The study is a Phase 3, randomized, double-blind, multicenter trial focused on adults aged 18 to 75 years who have had gout for at least one year. Participants receive either dotinurad or allopurinol in over-encapsulated tablet form, taken orally. The treatments are compared to see which better lowers sUA levels below 5.0 mg/dL after 24 weeks. The study includes a screening period before treatment begins, during which eligibility is confirmed, including measurements of tophi size and uric acid levels. During the study, participants will have regular assessments to monitor serum uric acid levels and the size of tophi. Safety and side effects will also be monitored throughout the 24-week treatment period. The main outcome is the percentage of participants who achieve sUA levels less than 5.0 mg/dL at week 24, helping to understand the comparative efficacy and safety of the two medications.

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 effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.

Researchers are evaluating the GalaFLEX LITE
22 Scaffold for its safety and effectiveness in revision surgery to reduce the recurrence of capsular contracture and/or implant malposition in women undergoing breast implant revision after augmentation. This prospective, randomized, controlled study compares the GalaFLEX LITE
22 Scaffold to standard surgery without supportive matrices or acellular dermal matrices (ADM). The study focuses on patients with Baker grade III or IV capsular contracture, a common complication after breast augmentation affecting 10 to 20% of patients. Participants will be randomly assigned in a 2:1 ratio to receive either the GalaFLEX LITE
22 Scaffold, a bioabsorbable surgical mesh made from poly-4-hydroxybutyrate designed to reinforce soft tissue, or standard surgery without any scaffold. The trial will include between 250 and 530 treated breasts and uses an adaptive design to assess outcomes. The primary endpoint includes recurrence of capsular contracture or implant malposition needing surgery, breast infections requiring antibiotics within 90 days, or peri-implant fluid collections needing drainage within 10 to 90 days post-surgery. During the study, participants will be followed for 24 months after their revision surgery. Researchers will monitor the stability of the implant pocket and assess complications through clinical evaluations. Participants will attend regular follow-up visits to track outcomes, safety, and any adverse events. The study aims to provide detailed information on the effectiveness of the GalaFLEX LITE
22 Scaffold in improving surgical outcomes and reducing common post-augmentation complications over a two-year period.