Chocen 1

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

Researchers are evaluating the safety and effectiveness of the study drug IPN10200 compared with a placebo for treating adults with Cervical Dystonia (CD). CD causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches. The condition may be influenced by brain function, genetics, and environmental factors. Current treatments involve botulinum toxin (BoNT) injections lasting about three months, but IPN10200 is designed to provide longer-lasting relief. Participants will receive a single intramuscular injection of IPN10200 at one of several doses or a placebo on the first day of the 36-week treatment period. The injections will be given into muscles in the head, neck, and shoulders. Before treatment, there is a screening period lasting up to four weeks to confirm eligibility. Some participants may continue other medications during the study, with all treatments recorded. The study involves about 40 weeks of participation, including screening and treatment. Participants will attend 10 to 12 in-person clinic visits plus one remote phone visit. During these visits, they will undergo blood and urine tests, physical and neurological exams, and clinical assessments. Questionnaires will also be completed to evaluate symptoms and treatment effects. The main outcome measured is the change in cervical dystonia severity four weeks after treatment based on a standardized rating scale.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 for people with agitation linked to Alzheimer's dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to compare ITI-1284 to a placebo in patients aged 55 years and older who meet specific criteria for Alzheimer's disease and agitation. Participants will be involved in three main periods: a screening phase of up to 4 weeks to confirm eligibility; a 12-week double-blind treatment phase where patients will be randomly assigned to receive either ITI-1284 (10 mg or 20 mg) or a placebo, both given once daily as a rapidly disintegrating tablet under the tongue; and a 30-day safety follow-up period after the last dose to monitor any safety concerns. During the study, participants will undergo various assessments including agitation severity measured by the Cohen-Mansfield Agitation Inventory at Week 12. Other evaluations include cognitive testing, clinical global impressions, and monitoring for side effects. Researchers will track adherence and safety through visits and questionnaires over the total study duration, which includes screening, treatment, and follow-up.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and effectiveness of ACP-204 in adults with Lewy Body Dementia Psychosis (LBDP). Participants eligible for this study are adults aged 55 to 84 years who meet specific clinical criteria for Parkinson's disease dementia or probable dementia with Lewy bodies, along with psychosis criteria established for neurocognitive disorders. Participants will be assigned to receive either ACP-204 or a placebo, each provided as one capsule taken orally once daily for six weeks. This parallel-group study maintains blinding to ensure unbiased assessment of the treatment effects over the 6-week period. During the study, researchers will monitor changes from baseline in the SAPS-LBDP total score at Week 6 to assess psychosis symptoms. Participants will undergo various evaluations and assessments to ensure safety and adherence throughout the study duration, with detailed criteria guiding enrollment and exclusion to maintain participant well-being.