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Found 5 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effects of LY3439539 on specific proteins found in the spinal fluid of people with Alzheimers disease. This phase 1, open-label study focuses on understanding how this investigational drug changes cerebrospinal fluid biomarkers related to Alzheimers. Participants will have symptomatic Alzheimers and meet specific memory and biomarker criteria to join the study. Participants will receive LY3439539 through intravenous IV administration. The treatment involves multiple doses, and the study is designed as a single group where all participants receive the same drug. The study lasts about 9 months, with visits approximately once a month to monitor treatment and collect necessary data. During the study, participants will undergo assessments including cerebrospinal fluid and blood tests to measure changes in biomarkers like neurofilament light chain and phospho-Tau. Researchers will also monitor the drugs concentration in the blood. Participants will have support from study partners and will be evaluated regularly for safety and treatment effects throughout the study period and follow-up.
Actively Recruiting
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.
Actively Recruiting
This research aims to evaluate the safety of abdominal vagus nerve stimulation aVNS in adults with moderate to severe rheumatoid arthritis RA that has not responded to medication. This open-label study involves participants with drug-refractory RA, assessing how the implanted aVNS device performs and its safety over time. The trial is conducted by The Bionics Institute of Australia and focuses on adult-onset RA patients aged 18 to 75 years. Participants will receive the aVNS device implanted via keyhole laparoscopic surgery. Starting two weeks after implantation, stimulation will be delivered daily for three hours each day during the initial 22-week treatment phase. After this initial phase, participants may choose to continue using the device or have it deactivated, though the device remains implanted unless removal is clinically necessary or requested. The follow-up phase includes monitoring participants twice a year for up to five years. Throughout the study, participants will undergo clinical assessments of RA symptoms and device performance at 2, 6, 12, and 24 weeks after surgery. Safety reports and device checks will be conducted during these visits. After the initial treatment phase, ongoing monitoring for safety and device function will continue biannually for up to five years. Overall, participants are involved in the trial for approximately five years, during which their health and device outcomes are closely observed.
Actively Recruiting
Researchers are studying participants with chronic Venous Leg Ulcers VLUs to see if adding TR987 0.1% gel to the Standard of Care improves healing compared to Standard of Care alone. This Phase 3, randomized, double-blind trial aims to evaluate the effectiveness and safety of the TR987 gel in treating VLUs, a type of non-healing wound caused by venous insufficiency. Participants will be assigned to one of two groups one group will receive TR987 0.1% gel applied topically along with Standard of Care treatments like wound cleansing, dressings, and compression bandaging the other group will receive Standard of Care alone. Treatments will be applied twice weekly for the first four weeks, then once weekly for the following 12 weeks, totaling up to 16 weeks of treatment. During the study, participants will have their target ulcer monitored for complete closure at various time points, including the 12- and 16-week marks, as well as follow-up at three months after closure. Pain levels and changes in ulcer size will also be assessed. Safety and tolerability will be tracked throughout the trial. Participation involves regular visits for treatment and evaluation over the 16-week treatment period, with additional follow-up to assess lasting ulcer closure.