Bloomfield Hills

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers DFUs and venous leg ulcers VLUs. The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the efficacy of selnoflast compared with a placebo in adults with atherosclerosis who are at high risk for major adverse cardiovascular events MACE and are currently receiving standard-of-care therapy. This Phase IIa study aims to assess how selnoflast affects vascular inflammation in this population. Participants will be randomly assigned to one of two groups one group will receive selnoflast orally twice a day for 12 weeks, while the other group will receive a matching placebo on the same schedule. The study uses a quadruple masking design to compare the effects of selnoflast and placebo over the treatment period. During the 12 weeks of treatment, participants will undergo assessments including imaging scans to measure vascular inflammation, blood tests for drug concentration, and monitoring for adverse events. The primary outcome is the change in a vascular inflammation measure called mdsTBR in a target blood vessel from baseline to week 12 in participants with elevated baseline inflammation levels. Safety and pharmacokinetics will be followed up to about 20 weeks. Overall participation lasts up to approximately 6 months.

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating CRD-4730, a calciumcalmodulin-dependent protein kinase II CaMKII inhibitor, in adults with heart failure with reduced ejection fraction HFrEF. This Phase 2, global, multi-center trial aims to assess the safety, tolerability, and effectiveness of CRD-4730 alongside guideline-directed medical therapy. Participants have chronic heart failure with a reduced heart pump function and are classified as New York Heart Association NYHA class II to III. Participants are randomly assigned to one of four groups to receive either one of three doses of CRD-4730 or a matching placebo. The study drug or placebo is given orally twice daily for a treatment period of 24 weeks. This double-blind trial ensures that neither participants nor researchers know which treatment is administered during the study. During the trial, participants undergo assessments including heart function tests, blood biomarker measurements, and questionnaires at baseline, mid-treatment week 12, and after 24 weeks of treatment. The main outcome measured is the change from baseline in a composite score at 24 weeks. Safety and response are monitored throughout, with total participation lasting about six months.

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

Researchers are evaluating the safety, tolerability, pharmacodynamics, and effectiveness of multiple increasing doses of CNP-103 in people aged 12 to 35 who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b2a first-in-human clinical trial aims to better understand how CNP-103 works in this population and to assess any immune safety concerns. Participants receive three intravenous doses of CNP-103 at varying amounts 100 mg, 300 mg, or 600 mg on Days 1, 8, and 90. The study includes multiple groups, including adolescent and adult cohorts, with dosing for an expansion group determined based on initial results. A placebo containing 0.9% sodium chloride is also used for comparison. The trial follows a parallel design with random assignment and double masking. The study lasts approximately 393 days and consists of a 28-day screening period, a 90-day treatment period, and a 275-day post-dose evaluation phase. Participants will be monitored for safety and immune safety throughout the entire year. Various assessments will be conducted during visits to track the effects and tolerability of the study drug, with regular follow-up to evaluate long-term outcomes.