Torres Vedras

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation linked to Alzheimers Disease. This phase 3 trial aims to understand how these treatments impact agitation symptoms in this population. The study is sponsored by Bristol-Myers Squibb and uses rigorous methods to compare the investigational drugs against a placebo. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo, with doses given on specified days. The study is randomized, double-blind, and placebo-controlled, ensuring objective assessment of treatment effects over a 14-week period. The trial includes a parallel group design where participants are assigned to either the experimental treatment group or placebo group. During the study, participants will be assessed for changes in agitation using the Cohen-Mansfield Agitation Inventory and other related scales at week 14. Researchers will monitor safety through adverse event reports, clinical labs, vital signs, ECGs, and specific rating scales up to week 18. Caregivers will assist by attending visits and reporting on participant status. Total participation involves regular visits and assessments over the course of the trial.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how KarXT affects psychotic symptoms in this population. The study is sponsored by Karuna Therapeutics, a Bristol Myers Squibb company. Participants will be randomly assigned to receive either KarXT or a placebo, both given in specified doses on designated days. The study treatment will be compared over a 14-week period to assess changes in psychosis symptoms and other measures related to cognition and behavior. During the study, participants will undergo various assessments including the Neuropsychiatric Inventory-Clinician NPI-C to measure hallucinations and delusions, clinical global impression scales, cognitive tests like the Mini-Mental State Examination MMSE and Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog-13, as well as monitoring for adverse events and safety parameters. These evaluations will help researchers determine how KarXT impacts symptoms and safety up to week 14 of the trial.

Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease who are already on stable levodopa treatment. This phase III study aims to better understand how prasinezumab affects the progression of motor symptoms in this population. Participants will be randomly assigned to receive either prasinezumab or placebo through intravenous IV infusions during a double-blind treatment period. After completing this phase, eligible participants can join an Open Label Extension OLE phase where they will receive prasinezumab. The treatments are given as scheduled IV infusions. During the study, participants will undergo regular assessments including evaluations of motor function using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III. Blood samples will be taken to measure drug levels and immune responses. Safety will be closely monitored, including tracking adverse events and infusion reactions. The primary outcome is the time until confirmed motor progression, with follow-up lasting up to at least 104 weeks.

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 investigating the frequency of specific single nucleotide polymorphisms SNPs in individuals who carry the Huntington Disease gene expansion. The study aims to understand how these genetic variations appear on both the mutant and wild-type Huntington alleles. Participants will be recruited from Huntington Disease clinics to provide insights into genetic differences related to this condition. Participants will attend a single-day visit at the study site where they will answer questions about their demographics, medical history, and medication use. At the end of the visit, a blood sample will be collected for testing using a sequencing assay designed to detect SNPs specifically phased on the mutant and wild-type Huntington alleles. This study does not involve any treatment or intervention. During the visit, researchers will gather detailed information through questionnaires and a blood draw. The primary outcome is the frequency of selected SNP alleles associated with the Huntington Disease gene expansion. Secondary outcomes include the number of participants with these SNPs according to their medical history, medication use, and demographic factors such as age, sex, ethnicity, and race. Participation involves only this one visit, with no long-term follow-up required.

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.