Motherwell

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 Alzheimers 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 evaluating KarXT for preventing relapse in people with psychosis linked to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study lasts 38 weeks and involves outpatients aged 55 to 90 years. The main goal is to compare how well KarXT works versus placebo in stopping psychosis relapse, while also assessing time to treatment discontinuation, safety, and tolerability. Participants receive either KarXT capsules at varying doses from 20 mg2 mg to 66.7 mg6.67 mg taken three times daily or placebo capsules. The study is conducted across multiple centers and uses a quadruple masking design to keep participants and researchers unaware of treatment assignments. The treatment phase spans 38 weeks, during which participants visit outpatient clinics regularly. Throughout the study, participants and their caregivers attend visits to monitor symptoms, side effects, and overall health. Assessments include measuring cognitive function with the Mini-Mental State Examination, tracking neuropsychiatric symptoms and caregiver distress, evaluating movement disorders, body weight, vital signs, laboratory tests, ECGs, and suicidal thoughts. Safety is closely observed up to approximately 42 weeks. The main outcome measured is the time from randomization to relapse by week 38.

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 Alzheimers 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 606 mg to 20020 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 the combination of KarXT and KarX-EC as a treatment for psychosis linked to Alzheimers disease in adults aged 55 to 90. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of these drugs in managing symptoms such as hallucinations and delusions related to this condition. Participants will be assigned to receive either the KarXT plus KarX-EC treatment or a matching placebo, with specified doses given on certain days over approximately 14 weeks. The study will monitor changes in neuropsychiatric symptoms, agitation, and caregiver distress, along with safety measures including adverse events and laboratory tests. During the trial, participants will undergo various evaluations such as neuropsychiatric inventories, clinical global impressions, cognitive assessments, and safety monitoring through lab tests, vital signs, and symptom tracking. The primary outcome focuses on changes in hallucinations and delusions up to week 14, with ongoing review of additional cognitive and safety outcomes throughout the study period.

Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimers Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatments impact over the 24-week period.

Researchers are evaluating the long-term safety and effectiveness of a combined treatment using xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for people with agitation associated with Alzheimers 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 developing a database to study digital and blood-based biomarkers and their relationship with tau and amyloid brain pathology detected by PET imaging in older adults. The study includes participants who are cognitively normal, have mild cognitive impairment, or have mild-to-moderate Alzheimers disease dementia. The goal is to understand how these biomarkers relate to brain changes associated with Alzheimers disease and memory disorders. Participants will provide blood samples and undergo brain imaging, including PET scans using either an FDA-approved tracer or an investigational one, as well as MRI scans. Genetic samples will also be collected to explore genetic factors related to Alzheimers disease and treatment responses. Some samples will be stored for future research. The study lasts 120 days and includes a cross-sectional assessment. Throughout the study, participants will undergo blood sampling, PET scans, MRI scans, and cognitive testing, including the Mini-Mental State Exam. Researchers will track biomarkers and imaging results over an average of three years. Participants will also have study partners who provide information about their cognitive and functional abilities. The study collects comprehensive data to better understand Alzheimers disease and related conditions in older adults.

This research investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimers Disease. It is a Phase 3, global, open-label extension study lasting 52 weeks that enrolls subjects who have completed previous related studies CN012-0026, CN012-0027, or CN012-0056. The study focuses on ensuring that KarXT is safe for extended use in this population. Participants receive KarXT capsules at varying doses ranging from 202 mg to 66.76.67 mg taken three times daily, with total daily doses between 606 mg and 20020 mg. This open-label extension allows subjects from the earlier studies to continue treatment and monitoring under this protocol. Throughout the 52-week study, participants will be monitored for treatment-emergent adverse events, serious adverse events, and any side effects leading to withdrawal. Assessments include regular safety evaluations from the initial dose through 14 days after the final dose, totaling up to 54 weeks. Participants will work with caregivers and study staff to complete necessary evaluations and ensure adherence to study requirements.