Boulder

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

Researchers are comparing the survival rates of different ceramic dental implants in adults with missing or hopeless teeth. This observational study focuses on two types of CeraRoot ceramic implants one-piece and two-piece TL models. The study aims to determine if there are significant differences in implant survival and to identify any complications associated with the procedures in these groups. The study involves patients from two dental centers in Barcelona, Spain, and Boulder, Colorado, USA. Participants will receive either one-piece or two-piece CeraRoot ceramic dental implants. These implants are specially designed for patients with metal allergies or chronic illnesses related to metal allergies. The study will follow patients for at least 12 months after enrollment to monitor implant survival and complications. During the study, researchers will collect information on implant survival rates and any complications occurring within one year after treatment. Participants will undergo dental assessments to evaluate implant status and oral health. The studys main outcome is the survival rate of the implants over 12 months or longer. This long-term follow-up helps understand the performance and safety of these ceramic dental implants in real-world clinical settings.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

Researchers are evaluating the efficacy and safety of HBS-301 in adults aged 18 years and older who have idiopathic hypersomnia IH, a condition marked by excessive daytime sleepiness EDS. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how HBS-301 affects symptoms of IH including sleep inertia, fatigue, and cognitive complaints. Participants will be assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking during an 8-week double-blind treatment period. Following this, there is an optional one-year open-label extension where all participants may receive HBS-301. The study begins with a screeningbaseline period lasting up to 28 days and concludes with 30 days of safety follow-up after treatment. During the trial, participants will undergo various assessments including the Epworth Sleepiness Scale to measure daytime sleepiness, the Idiopathic Hypersomnia Severity Scale, Sleep Inertia Questionnaire, and other patient-reported outcome measures. Researchers will monitor changes in fatigue, cognitive function, quality of life, work productivity, and side effects throughout the study and extension period. Total participation may last up to about 16 months including safety follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Alzheimers disease AD is a progressive and irreversible neurological disorder that commonly causes dementia in older adults. This research aims to evaluate the safety, effects, and how the body processes ABBV-1758, an investigational drug developed to treat Alzheimers disease. The study is conducted in three stages, including dose escalation and expansion phases, involving approximately 210 participants across the United States, China, and Japan. Participants will receive intravenous IV or subcutaneous SC ABBV-1758 or placebo injections once every four weeks for a period of 24 weeks. The study includes a Follow-up Period lasting 12 weeks after treatment, and participants may opt to join a 12-month blinded Extension Period based on specific brain imaging results. Randomization assigns participants to different doses or placebo groups throughout the three stages, ensuring a 41 chance of receiving ABBV-1758 versus placebo. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor safety and treatment effects. Researchers will measure outcomes such as adverse events, changes in laboratory tests, brain amyloid levels, and other vital signs over approximately 40 weeks. The study emphasizes monitoring brain imaging abnormalities and drug levels in the body to better understand ABBV-1758s impact.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

This research aims to evaluate the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 NT1. The study focuses on measuring reductions in daytime sleepiness, cataplexy sudden loss of muscle tone, and overall disease symptoms. Participants diagnosed with NT1 according to official guidelines are included to assess the impact of the treatment compared to placebo. Participants will be randomly assigned to one of three groups two different doses of ALKS 2680 or a placebo. Each participant will take oral tablets daily for 12 weeks. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial to thoroughly evaluate the drugs efficacy and safety during this period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, along with various scales and inventories to evaluate sleepiness, cataplexy rates, cognitive complaints, fatigue, and narcolepsy severity. Safety will be monitored through reports of adverse events over approximately 14 weeks. The total participation time spans the 12-week treatment period and follow-up for safety monitoring.