Harris County

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 a combination treatment called KarXT and KarX-EC for adults aged 55 to 90 who have agitation linked to Alzheimer's Disease. This Phase 3 study aims to understand how this treatment may help manage agitation symptoms in this population, with careful monitoring of side effects and overall safety. Participants will receive either the KarXT plus KarX-EC treatment or a placebo, with doses given on specified days as capsules. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. The treatment period lasts 14 weeks, during which participants are closely observed. During the study, participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) score to measure agitation changes at week 14. Additional evaluations include clinical global impressions, neuropsychiatric inventories, safety monitoring through lab tests, vital signs, body measurements, and assessment of side effects up to week 18. Caregivers will also report on participants' status, and safety will be closely followed throughout the trial.

Researchers are studying the safety and effects of combined doses of ensifentrine and glycopyrrolate in adults with chronic obstructive pulmonary disease (COPD). This Phase IIb trial compares two doses of the combination to each drug alone and to a placebo, aiming to evaluate their ability to improve lung function in adults aged 40 to 80 years with COPD symptoms and a history of smoking. Participants will be randomly assigned to one of six groups: two groups will receive fixed combinations of ensifentrine 3 mg with either 21.25 mcg or 42.5 mcg glycopyrrolate; two groups will receive glycopyrrolate alone at one of the two doses; one group will receive ensifentrine alone; and one group will receive a placebo. All treatments are inhaled twice daily using a standard jet nebulizer over a 28-day period. The study lasts about seven weeks, including 1 to 2 weeks for screening, 4 weeks of treatment, and a 1-week follow-up. Participants will undergo lung function tests measuring forced expiratory volume in one second (FEV1) at various time points and complete questionnaires about symptoms and quality of life. Researchers will monitor safety, lung function changes, symptom improvements, and adverse events throughout the study.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

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 evaluating KarXT in a Phase 3, randomized, double-blind, placebo-controlled study for adults aged 55 to 90 years with mild to severe Alzheimer's Disease (AD) who experience moderate to severe psychosis related to AD. The study aims to assess the safety and effectiveness of KarXT compared with placebo, focusing on psychosis symptoms using the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions score. Participants will be randomly assigned to receive either KarXT capsules or placebo capsules. KarXT dosing includes various total daily doses ranging from 60/6 mg to 200/20 mg of xanomeline and trospium chloride. The treatment period lasts up to 14 weeks, during which researchers will monitor changes in psychosis symptoms and other related measures. During the trial, participants will undergo assessments including the NPI-C for hallucinations, delusions, agitation, and aggression, as well as the Clinical Global Impressions-Severity scale. Brain imaging such as MRI or CT scans must be available or performed. Study partners with daily contact will help provide information. Safety and efficacy will be monitored throughout the treatment, with the main outcome measured at the end of treatment.

Researchers are evaluating ITI-1284 for treating psychosis in patients with Alzheimer's disease. This multicenter, randomized, double-blind, placebo-controlled Phase 2 study aims to assess the efficacy, safety, and tolerability of ITI-1284 in comparison to a placebo. Psychosis symptoms related to Alzheimer's disease present challenges that this study seeks to address under controlled conditions. The study includes three periods: a screening phase up to 4 weeks to determine eligibility; a 6-week double-blind treatment phase where participants are randomly assigned to receive either ITI-1284 or placebo; and a 30-day safety follow-up period after the last dose to monitor participants' health. ITI-1284 is given as a 10 mg or 20 mg rapidly disintegrating tablet taken once daily under the tongue. Participants will attend study visits for assessments including psychosis symptom scoring using the BEHAVE-AD psychosis subscale and clinical global impressions at baseline and week 6. Caregivers are involved in the process, and safety monitoring continues through the follow-up visit about 30 days after treatment ends. The study's total participation time includes screening, treatment, and safety follow-up, ensuring close observation of patients throughout.

Researchers are evaluating BHV-7000 as a treatment for adults with refractory focal onset epilepsy, a form of epilepsy that does not respond to standard anti-seizure medications. The study aims to determine if BHV-7000 can reduce seizure frequency and assess its safety and tolerability. This Phase 2/3 clinical trial is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 75 years with a diagnosis of focal epilepsy lasting at least one year and resistant to previous treatments. The trial consists of two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000 once daily or a matching placebo. After completing Part A, participants may enter Part B, which involves randomization to either 75 mg of BHV-7000 once daily or placebo. Both parts are blinded, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment periods. Participants will keep accurate seizure diaries throughout the study to track seizure frequency. Researchers will monitor safety by recording adverse events and laboratory abnormalities from Week 8 to Week 20 in both parts. The main outcome measured in Part B is the change in average seizure frequency over 28 days compared to baseline. Secondary outcomes include the percentage of participants with significant seizure reduction and seizure freedom during the study. The total participation duration includes treatment and follow-up assessments over several weeks.

Researchers are evaluating the long-term safety and effectiveness of a combined treatment using xanomeline tartrate/trospium chloride in an immediate release capsule (KarXT) and xanomeline enteric capsules (KarX-EC) for people with agitation associated with Alzheimer's Disease. This study includes participants who have completed previous related studies CN012-0023 or CN012-0024. The goal is to observe how well these treatments work and how safe they are over an extended period. The study involves giving participants specified doses of KarXT and KarX-EC on certain days. This is an open-label study, meaning both the researchers and participants know what treatment is being given. The trial is non-randomized and does not include a placebo group. The treatment period lasts up to about 30 weeks, during which participants take the study medications and are closely monitored. Participants will be involved in regular assessments throughout up to approximately 30 weeks. Researchers will track any treatment-emergent side effects and other adverse events, along with specific measures such as movement scales, body weight and BMI changes, heart rate and blood pressure checks, laboratory tests, ECGs, and cognitive assessments like the Mini-mental State Examination and ADAS-Cog. Safety monitoring includes assessment of suicidal thoughts and prostate symptom severity. This comprehensive monitoring aims to understand the treatment impacts and participant safety during the study.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second (FEV1), record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.