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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.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

Researchers are studying the safety and performance of the LEGION Medial Stabilized insert used in total knee arthroplasty TKA for patients with degenerative joint disease such as osteoarthritis, post-traumatic arthritis, or inflammatory arthritis. This observational study includes both prospective and retro-prospective participants and aims to provide long-term evidence to support product registration worldwide. The study involves three groups receiving different LEGION MS insert combinations with tibia and femoral components Cemented CoCr, Cemented Oxinium, and Cementless options. Participants will be followed for 10 years after their primary knee replacement surgery to monitor outcomes related to the implant. During the study, participants will undergo regular assessments including the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement KOOS JR, Oxford Knee Score, Forgotten Joint Score, and EuroQol Five-Dimensional EQ-5D-5L questionnaires at multiple timepoints from 6 weeks up to 10 years post-surgery. Implant survivorship will be tracked at intervals up to 10 years, with all participants consenting to follow-up visits and outcome reporting to evaluate long-term device safety and effectiveness.

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.

This research aims to evaluate whether participants who previously took donanemab receive clinical benefits from annual doses of the drug. The study focuses on individuals with Alzheimer Disease, Dementia, and Amyloid Plaque accumulation. Sponsored by Eli Lilly and Company, it is a phase 3 trial designed to assess the treatments effects over a long period. Participants are randomly assigned to receive either donanemab or a placebo through intravenous IV administration. The study follows a parallel design with double masking to compare the outcomes between the two groups. The treatment period lasts up to 2.5 years, during which participants will have six visits, including drug administration and monitoring. Throughout the study, participants will undergo evaluations such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Cognitive Function Index CFI, brain amyloid plaque imaging with Florbetapir F 18 PET scans, and plasma tests for phosphorylated tau protein. Pharmacokinetics of donanemab will be measured at baseline, week 52, and week 104. The study involves close monitoring of safety and clinical changes over the entire duration.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying the safety and effects of a medicine called Mevrometostat for treating three types of cancer RelapsedRefractory Small Cell Lung Cancer SCLC, Castration Resistant Prostate Cancer CRPC, and Follicular Lymphoma FL. This study is a Phase 1 trial that includes three parts, with Parts 1 and 2 now closed for enrollment. The current enrollment is open for men with CRPC who have previously been treated and whose disease has progressed since their last treatment. The purpose is to evaluate how Mevrometostat works alone or combined with other treatments in these cancers. The study involves giving Mevrometostat by mouth either alone or with other drugs such as Enzalutamide and Itraconazole, depending on the specific part or cohort. Part 3 consists of two substudies a Bioequivalence BE substudy where participants take three single doses of two Mevrometostat formulations over three periods, and a Drug-Drug Interaction DDI substudy with two cohorts receiving Mevrometostat alone or combined with Enzalutamide andor Itraconazole. After these assessment phases, participants enter a maintenance phase where they take Mevrometostat twice daily and Enzalutamide once daily until the cancer no longer responds. During the study, participants will be closely monitored for safety, including adverse events, laboratory tests, and vital signs over about two years. The researchers will also assess how well the drug works by measuring cancer response and progression-free survival. Pharmacokinetic studies will track how the drug behaves in the body. Patient experiences and symptoms will be evaluated through questionnaires. Overall, participants can expect regular visits to receive the study drugs, undergo testing, and provide feedback throughout their participation, which may last until disease progression or study completion.

Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 NT1, Narcolepsy Type 2 NT2, and Idiopathic Hypersomnia IH. These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.