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Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of KarXT in men and women aged 55 to 90 years who have mild to severe Alzheimer's Disease with moderate to severe psychosis related to the condition. The main goal is to compare KarXT against a placebo by measuring changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician (NPI-C) score. Participants will receive different doses of KarXT ranging from 20/2 mg to 66.7/6.67 mg daily or placebo capsules. The study is designed to compare the effects of KarXT with placebo in a parallel group format, maintaining the double-blind setup to ensure unbiased results. During the study, participants will be assessed at the start and end of treatment (up to 14 weeks) to evaluate changes in psychotic symptoms. They will undergo clinical scales such as the NPI-C and the Clinical Global Impression-Severity (CGI-S) scale. The study also requires imaging scans like MRI or CT to rule out other brain diseases. A study partner who has regular contact with the participant will be involved to support adherence and observation. Safety and efficacy will be monitored throughout the treatment period.

Researchers are evaluating the effectiveness, safety, and tolerability of ITI-1284 compared to a placebo in treating psychosis associated with Alzheimer's disease. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients aged 55 and older who meet specific clinical criteria for Alzheimer's disease and psychosis. The study aims to assess changes in psychosis symptoms using the BEHAVE-AD psychosis subscale score after 6 weeks of treatment. Participants will be randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is administered as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study includes three periods: up to 4 weeks of screening to determine eligibility, a 6-week double-blind treatment phase where participants receive their assigned medication, and a 30-day safety follow-up after the last dose to monitor any adverse effects. During the study, participants will undergo assessments to confirm Alzheimer's disease diagnosis and psychosis presence, including biomarker tests, clinical rating scales, and cognitive evaluations. Caregivers will be involved as designated support persons. Researchers will monitor symptom changes, safety, and tolerability throughout the treatment and follow-up periods. The primary outcome is the psychosis subscale score measured at week 6, with safety follow-up visits approximately 30 days after treatment ends.

The trial investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's Disease. This Phase 3 global, multicenter, open-label extension study lasts 52 weeks and enrolls participants who have completed earlier related studies (CN012-0026, CN012-0027, or CN012-0056). The purpose is to monitor how well patients tolerate KarXT over an extended period and to collect safety data. Participants receive KarXT in varying doses taken three times daily, ranging from 20/2 mg up to 66.7/6.67 mg per dose, corresponding to total daily doses between 60/6 mg and 200/20 mg. This treatment is provided throughout the 52-week open-label extension. The study includes only those who completed the previous related studies and continues to assess their response to KarXT over this longer timeframe. During the study, participants are closely monitored for treatment-emergent adverse events from the first dose through 14 days after the final dose, which may be up to 54 weeks. Regular assessments ensure safety and tolerability, and caregivers are involved to support participants. The study also evaluates participants' ability to continue living in their current setting and requires consent from the participant or their legal representative. Overall, the study tracks long-term safety outcomes in this specific patient group.

This study is designed to identify individuals who may be eligible for future Roche clinical trials focused on Alzheimer's disease. It serves as a pre-screening step to evaluate participants based on biomarker status and cognitive performance. The study targets adults aged 50 to 90 years who have experienced memory concerns recently, with or without a diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease. Participants do not receive any intervention during this study. Instead, they will have their blood drawn to measure the concentration of a biomarker called pTau217 and will undergo a cognitive assessment using the ISLT (International Shopping List Test) on the first day of participation. This process helps researchers determine potential eligibility for more extensive Alzheimer's disease trials. During the study, participants will be evaluated for memory concerns and cognitive function through blood tests and cognitive scoring. Researchers will monitor biomarker levels and cognitive scores on the first day to help assess trial eligibility. The study includes safety assessments to ensure participants can safely complete these procedures, with participation lasting for the duration of the pre-screening evaluations.