Plymouth Meeting

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

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.

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 eyes 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 DSLTs 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 effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Researchers are evaluating the efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

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 who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.