Bloomfield Hills

Researchers are evaluating the safety, tolerability, and effectiveness of DermaBind TL, a placental membrane allograft, in adult patients with chronic non-healing wounds such as diabetic foot ulcers and venous leg ulcers. This Phase 4, open-label, single-arm clinical trial aims to collect patient outcome data over a 12-week treatment period, comparing results to each participant's historical treatment data. The study focuses on wound area preservation, infection rates, wound recurrence, graft usage, and treatment-emergent adverse events. During the 12-week treatment phase, participants will receive DermaBind TL applied to their affected chronic wounds. The trial involves two phases: screening and treatment. Clinicians will assess wounds regularly, and the intervention will be monitored for its ability to protect wounds, reduce infections, and promote healing. The study includes careful evaluation of wound characteristics and patient response to the graft treatment. Participants will be closely monitored throughout the trial, including wound assessments by clinicians and data collection on infection rates, wound size, and safety events. The primary outcome is to measure how well the wound covering protects the wound over the 13-week treatment period. The study also tracks adverse events and other clinical outcomes through the end of the study. Overall participation includes screening and a 12-week treatment period, with detailed follow-up to evaluate the intervention's effects.

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

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 comprehensive genomic analysis in tissue samples from patients with recurrent or stage IV non-small cell lung cancer. This analysis aims to identify specific gene mutations in the cancer's DNA, which may help doctors tailor treatments to target these mutations more precisely. The study seeks to determine how often therapy can be started based on these genomic test results and to understand the outcomes for patients who receive such targeted therapy. Patients provide tumor tissue samples for genomic analysis using techniques like mass spectrometry, polymerase chain reaction (PCR), and microarray. Those whose genomic results indicate suitable targets may begin therapy tailored to their tumor's specific mutations. The study involves collecting and analyzing existing tumor samples or performing new biopsies if needed. During the study, patients undergo laboratory tests and tissue collection, followed by therapy initiation when appropriate. After treatment, patients are monitored every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter to track progression-free survival and response to therapy. The main outcome measured is the proportion of patients who start treatment based on genomic analysis within 21 days. Safety and long-term outcomes are also followed.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride (KarXT) in adults diagnosed with schizophrenia in the United States. This study aims to describe how patients respond to KarXT treatment and the related adverse events as observed in routine clinical care. Participants receive xanomeline and trospium chloride (KarXT) following the product label instructions. They may either be starting KarXT treatment within 16 weeks with plans to stop previous antipsychotics or already on a stable antipsychotic regimen and switching to KarXT under their clinician's guidance. Other psychiatric medications like antidepressants or mood stabilizers can be continued at stable doses during the study. During the study, participants' treatment adjustments and switches are tracked from baseline up to 20 weeks. Researchers monitor treatment effectiveness and safety through regular clinical follow-up, recording any changes, side effects, or adverse events. The study relies on the treating clinician’s judgment to assess treatment progress and participant safety throughout the observation period.

Researchers are evaluating the efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during the study period.