Whitby

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 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 safety and effectiveness of KarXT combined with KarX-EC as a treatment for psychosis linked to Alzheimer's disease. This Phase 3 clinical trial focuses on people aged 55 to 90 years diagnosed with Alzheimer's disease and experiencing psychotic symptoms, such as hallucinations and delusions. The study aims to understand how this treatment affects these neuropsychiatric symptoms over approximately 14 weeks. Participants will receive either KarXT plus KarX-EC or a matching placebo at specified doses on designated days. The study is double-blind and placebo-controlled, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial. This parallel group design helps compare the treatment's impact against no active drug. During the study, participants will be monitored for changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician scale up to about week 14. They will also undergo brain imaging review from recent MRI or CT scans to confirm eligibility and rule out other causes of dementia. Safety and efficacy will be carefully assessed throughout the trial period, ensuring close observation of any side effects or improvements.

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 investigating whether giving intravenous hyperoncotic albumin (20-25%) compared to normal saline boluses during renal replacement therapy (RRT) improves outcomes in critically ill patients with Acute Kidney Injury requiring RRT (AKI-RRT). This Phase 4 trial addresses the high risk of death and complications associated with severe AKI needing RRT, aiming to see if albumin can increase the number of days patients are free from organ support and RRT within 28 days after randomization. Participants will be randomly assigned to receive either albumin (20-25%) or normal saline as two 100 mL boluses during each RRT session in the ICU. The boluses are given at the start and halfway through the RRT sessions, which may include continuous RRT (CRRT), sustained low-efficiency dialysis (SLED), or intermittent hemodialysis (IHD). This treatment continues for up to 14 days while patients are receiving RRT. During the study, 856 ICU patients will be monitored for organ-support-free days over 28 days following randomization. Researchers will assess the safety and effectiveness of albumin by tracking how many days participants avoid organ support and RRT. The study includes careful monitoring of treatments, with randomization ensuring balanced comparison between albumin and saline groups across multiple Canadian hospitals and potentially other international sites.

Mood disorders such as depression and bipolar disorder affect over 350 million people worldwide. Finding the right treatment for each individual is challenging, often leading to poor functioning, lower quality of life, and longer recovery times. Unlike other areas of medicine that use biomarkers or clinical tests to guide treatment, mood disorders lack large, standardized studies needed to identify these helpful markers accurately. The ENABLE platform aims to provide a standardized way for the Canadian neuroscience community to collect biomarker data from people with various mood disorder symptoms and to create a pool of participants for future biomarker-based clinical trials. The ENABLE platform involves a tiered system of assessments. At tier 1, participants complete clinical assessments including both clinician-led interviews and self-report questionnaires. Tier 2 offers optional measures such as blood collection, neuroimaging procedures including MRI and EEG, and wearing an actigraphy device for two weeks to monitor activity. Participants will also be asked for consent to be contacted about participation in future clinical trials linked to the platform. Participants are involved through detailed clinical and neurobiological evaluations, providing data that supports further research and trial recruitment. Researchers will monitor the rate of participation in the master trial platform through March 31, 2026. The platform also offers an open source of clinical and neurobiological data for discovery analyses and grant applications, helping to advance mood disorder research and treatment development.

Researchers are evaluating the safety and effectiveness of cannabidiol (CBD) capsules for managing agitation in patients with Alzheimer's disease (AD). This randomized, double-blind, placebo-controlled cross-over trial also aims to identify new biomarkers linked to agitation severity and treatment response. Agitation is common in AD and is linked to physical health problems, disease progression, and caregiver burden. Current treatments may not work for everyone and have safety concerns, so this study seeks safer, more effective options to improve quality of life for patients and families. Participants will be randomly assigned to receive either CBD or a placebo for the first 8-week treatment period. This is followed by a two-week placebo washout, and then they will switch to the opposite treatment for another 8 weeks. The total treatment duration is 19 weeks, followed by 4 weeks of monitoring after treatment ends. The study involves 12 in-person visits every two weeks and 8 weekly phone calls to track progress. During the study, participants and their caregivers will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory, as well as evaluations of overall neuropsychiatric symptoms, caregiver distress, cognition, nutrition, and pain. Caregivers will assist with study visits and assessments. Safety will be monitored closely throughout the trial. The goal is to better understand how CBD affects agitation and related symptoms in AD over the study period.

Researchers are evaluating whether nabilone is an effective treatment for agitation in patients with Alzheimer's disease (AD). Agitation is common and difficult to treat in AD, leading to faster institutionalization, increased caregiver burden, poorer quality of life, and higher risk of death. Existing medications offer limited relief with notable side effects. This phase III trial builds on earlier promising results from a smaller pilot study that showed nabilone improved agitation, neuropsychiatric symptoms, and caregiver distress in moderate-to-severe AD patients. Participants will be randomly assigned to receive either nabilone or placebo capsules for 8 weeks. After the treatment period, participants will be followed for an additional 8 weeks to monitor ongoing effects. The study aims to assess not only agitation but also other outcomes such as overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Nabilone is a synthetic cannabinoid approved in Canada for chemotherapy-induced nausea and vomiting. During the study, participants and their primary caregivers will attend visits for assessments including agitation levels measured by the Cohen-Mansfield Agitation Inventory. Caregivers must be able to complete study assessments in English. Researchers will track changes from baseline to 8 weeks in agitation and other symptoms. Safety and efficacy will be monitored throughout the treatment and follow-up periods, with total participation lasting at least 16 weeks including screening and follow-up.

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.

Researchers are evaluating treatments for people with schizophrenia-spectrum disorders, focusing on how well Cognitive Behavioural Therapy for Psychosis (CBTp) and Cognitive Remediation Therapy (CR) work alone or combined. The study aims to understand which patients benefit from each therapy or from their combination, as current treatments improve symptoms but often do not enhance daily functioning significantly. This trial will be one of the largest psychosocial intervention studies for these disorders and will explore factors predicting treatment response and the mechanisms behind therapy effects. Participants will receive one of four interventions: individual CBTp weekly sessions focusing on understanding and changing difficulties; group-based action-based CR (ABCR) weekly sessions involving computer exercises, strategy discussions, and role-play; befriending sessions that provide social conversation without therapeutic techniques; or sham CR sessions involving non-progressive computer exercises and neutral discussions. Each intervention is delivered once per week with homework assigned to reinforce learning and practice cognitive strategies. During the study, participants' community functioning will be assessed, along with quality of life, personal recovery, psychiatric symptoms, and cognitive functioning. The main outcome measure is the change in social functioning between the start and 18 months later. Researchers will monitor therapy engagement and assess demographic, cognitive, and psychological factors to understand who responds best to each treatment. The study includes baseline and follow-up assessments to track these outcomes over time.