Plymouth Meeting

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. 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 treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimer's patients. Participants will be randomly assigned to receive either intravenous (IV) trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes (CDR-SB), and the Mini-Mental State Examination (MMSE). Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.

This trial investigates the effects of Fasedienol Nasal Spray in adults aged 18 to 65 with Social Anxiety Disorder (SAD) triggered by a public speaking challenge. It is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study aiming to assess the safety, tolerability, and effectiveness of repeated intranasal doses of Fasedienol to relieve acute anxiety symptoms in a clinical setting. Participants will be randomly assigned to one of three groups: one receiving a dose of Fasedienol followed by a placebo spray, another receiving two doses of Fasedienol, and a third receiving two doses of placebo spray. The sprays are administered twenty minutes before the public speaking challenge, with ten minutes between doses. Those who complete this phase may enter an open-label extension where they can use Fasedienol as needed, up to six times daily for up to 12 months to assess longer-term safety and tolerability. During the study, participants will undergo assessments including the Subjective Units of Distress Scale (SUDS), Clinical Global Impression of Improvement (CGI-I), and Patient Global Impression of Change (PGI-C) over seven days. Researchers will monitor symptoms of anxiety, safety, and tolerability through clinical evaluations. The total participation timeline includes initial treatment and possible extended use with ongoing observation until the study ends in December 2026.

This research aims to evaluate the use of Direct Selective Laser Trabeculoplasty (DSLT) in adults newly diagnosed with primary open-angle glaucoma or similar conditions such as ocular hypertension. The study focuses on untreated patients to understand how well DSLT reduces intraocular pressure (IOP) without requiring medications. It addresses the current need for alternatives to medications, which can be difficult to use due to side effects and adherence challenges. Participants will receive the DSLT procedure, which involves delivering 120 laser shots at the eye's limbus over 2.4 seconds to help control aqueous fluid outflow and lower IOP. The study measures the reduction in IOP at 1, 3, and 6 months, with the primary goal of achieving more than a 20% decrease without medications. Only patients with baseline IOPs above 21 mmHg and no prior glaucoma treatments will be included. During the study, participants will undergo regular eye pressure assessments to track treatment effects and determine the need for additional interventions. Researchers will monitor the percentage of eyes reaching the target IOP reduction and record any secondary treatments required. The total follow-up period for assessing outcomes is 6 months, ensuring a clear understanding of DSLT's impact on early-stage glaucoma management.

Researchers are conducting a prospective, randomized, multicenter study to compare three types of intraocular lens (IOL) implantations in adults with cataracts aged 40 years and older. The study is designed with two stages: an initial three-arm enrollment followed by a head-to-head comparison based on data from the first stage. The trial evaluates vision outcomes after cataract surgery using different Clareon lenses to better understand their effects on visual acuity and patient satisfaction. The study involves three treatment groups: bilateral Clareon PanOptix IOL implantation, bilateral Clareon PanOptix Pro IOL implantation, and a mixed approach with Clareon PanOptix Pro in one eye and Clareon Vivity in the other. Participants will receive their assigned lens implantations during cataract surgery. The study is masked so that subjects and vision assessors do not know which lenses are implanted to ensure unbiased evaluation. Participants will be monitored for at least three months after surgery, during which several visual acuity measurements will be taken, including corrected distance, intermediate, and near vision under different lighting conditions. Patient-reported outcomes about visual disturbances and satisfaction with the lenses will be collected through questionnaires. The study also measures contrast sensitivity, refractive outcomes, and pupil size. Safety and vision improvements will be regularly assessed throughout the follow-up period.

This research aims to evaluate the efficacy and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. The study targets approximately 200 participants aged 18 to less than 64 years who have chronic AD with symptoms ongoing for at least three years and significant disease activity. The trial is sponsored by AbbVie and conducted worldwide across up to 130 sites. The study is divided into two periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg oral tablets once daily or dupilumab 300mg subcutaneous injections every other week for 8 weeks. Those on upadacitinib 15mg may have their dose increased to 30mg after two weeks based on clinical response. In Period 2, lasting 24 weeks, participants continue or adjust their doses depending on their Eczema Area and Severity Index (EASI) response. Participants originally on dupilumab who show less than EASI 75 response will switch to upadacitinib 15mg. Participants will attend regular visits throughout the 35-day screening period, the 8-week open-label Period 1, and the 24-week open-label Period 2, followed by a 30-day safety follow-up. Assessments include medical exams, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The primary outcome is the proportion of participants achieving at least a 90% reduction in EASI score by Week 8. Secondary outcomes include improvements in itch severity measured by the Worst Pruritus Numerical Rating Scale.

Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC+ will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatment's impact over the 24-week period.

Researchers are evaluating the effectiveness of adding the drug tirzepatide to the existing treatment with ixekizumab in adults with moderate-to-severe plaque psoriasis who are also overweight or obese and have at least one related health condition. This Phase 4 study aims to understand how well this combination works in routine clinical practice over a period of up to 12 months. During the study, participants will continue their treatment with ixekizumab and will start taking tirzepatide by subcutaneous injection according to the medication label. The study is open-label and involves a single group of participants receiving this combined treatment regimen. The main focus is to assess improvements in quality of life and weight reduction over the 12-month period. Participants will be monitored regularly to measure their skin condition using tools like the Dermatology Life Quality Index and body surface area affected by psoriasis. Weight changes and other health assessments will be tracked at 6 and 12 months. Safety and treatment adherence will also be observed throughout the study duration to gather comprehensive data on the effects of adding tirzepatide to ixekizumab therapy.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 clinical trial aims to compare two different doses of TSND-201 against a placebo to better understand its impact on PTSD symptoms. Participants must have had PTSD symptoms for at least six months and have tried at least one previous treatment. Participants will be randomly assigned to one of three groups: one receiving TSND-201 at Dose Level 1, another receiving TSND-201 at Dose Level 2, and the third receiving a placebo. Each participant will take capsules orally once a week for four consecutive weeks during the Treatment Period. After this, they will enter an 8-week Follow-up Period where no study drug is given, but their condition will continue to be monitored. During the study, participants will undergo regular assessments including the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) to measure changes in PTSD symptom severity up to 12 weeks. The study includes careful safety monitoring and requires participants to communicate well enough to complete interviews and questionnaires. The total duration of participation covers the 4-week treatment plus the 8-week follow-up, allowing researchers to observe both immediate and lasting effects of the treatment.

Researchers are studying muvalaplin to see if it can reduce the risk of major heart problems in adults with high levels of lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. This Phase 3 trial is designed to provide strong evidence by comparing muvalaplin to a placebo in a large group of participants over several years. The study is sponsored by Eli Lilly and Company and focuses on adults with atherosclerotic cardiovascular disease or those at risk for it. Participants will be randomly assigned to receive either muvalaplin or a placebo, both taken by mouth. The trial is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. The study will last about 5.25 years, during which participants will be monitored closely. The primary goal is to measure the time until the first major adverse cardiac event occurs, including heart attacks and strokes. During the study, participants will have regular visits for assessments, including blood tests to measure lipoprotein(a) levels and pharmacokinetics of muvalaplin over the first 96 weeks. Researchers will track the occurrence of cardiovascular events, deaths, and healthcare resource use annually. Safety and adherence will be monitored throughout the study to ensure participant well-being and accurate data collection.