Torres Vedras

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of intravenous prasinezumab compared with placebo in people with early-stage Parkinson's disease. Participants must be on stable symptomatic monotherapy with levodopa and meet specific criteria including body weight and disease stage. This Phase III study aims to understand how prasinezumab affects motor progression in Parkinson's disease. Participants will receive either prasinezumab or a placebo through intravenous infusion following a schedule outlined in the study protocol. The study compares these two groups to assess the impact of prasinezumab on disease progression. The treatments are administered regularly over the course of the trial. During the study, participants will be monitored for motor progression using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III score, with assessments continuing up to at least week 104. Researchers will also evaluate safety and pharmacokinetics throughout the trial. Participants are required to adhere to contraception requirements and attend scheduled visits for evaluations and infusions.

Researchers are evaluating the effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

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 studying the frequencies of certain single nucleotide polymorphisms (SNPs) linked to the Huntington Disease gene in people who carry the gene expansion. This study is focused on understanding genetic variations on both the mutant and normal Huntington alleles. Participants will be individuals confirmed to carry the Huntington Disease gene expansion, aged between 25 and 60 years. The study involves a single visit to the study site where participants will answer questions about their demographics such as sex, age, race, ethnicity, and medical and medication history. At the end of this visit, a blood sample will be taken to perform genetic testing that identifies specific SNPs on the mutant and wild-type Huntington alleles. During the visit, researchers will collect data and a blood sample to analyze the genetic markers. The main outcome measured is the frequency of selected SNP alleles in relation to the mutant and wild-type Huntington alleles, assessed on the day of the visit. Participation requires the ability to tolerate blood draws and confirmation of disease status and functional capacity within the past year.

Migraine is a neurological condition causing moderate to severe headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research aims to assess how well atogepant works in adults with migraine when used in everyday medical practice. Atogepant is an approved preventive treatment for migraines, and the study will include about 1000 adult participants prescribed this medication by their doctors worldwide. Participants will take atogepant tablets orally as prescribed by their healthcare providers following usual medical care. The study will observe participants over a two-year period without requiring extra treatments or procedures beyond their regular clinical visits. These visits will occur at hospitals or clinics according to each participant's routine care schedule. During the study, participants will attend regular check-ups where researchers will monitor their health and migraine symptoms. The main outcome measured will be the percentage of participants who report feeling "much better" or "very much better" by week 12, based on their own impression of change. There are no additional burdens expected for participants beyond their normal treatment and follow-up appointments.

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.