Integrated Care for Agitation in Alzheimer's Disease
(StaN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach called the Integrated Care Pathway (ICP) to treat aggression and agitation in people with Alzheimer's disease. The ICP combines pharmacological interventions (medication treatments) and non-pharmacological interventions (non-medication treatments) based on thorough assessments to improve treatment decisions. Researchers aim to determine if this approach reduces unnecessary medication use and eases the burden on caregivers. Individuals diagnosed with Alzheimer's or mixed-type dementia who experience agitation might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative care strategies that could enhance the quality of life for those with Alzheimer's.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What prior data suggests that this Integrated Care Pathway is safe for treating agitation in Alzheimer's disease?
Research has shown that non-drug treatments can reduce agitation in people with Alzheimer's without harmful effects. Methods such as music or light therapy are promising because they manage symptoms safely.
For drug treatments, results have been mixed. Some medications can reduce agitation but may also cause side effects. For instance, citalopram has been used in some studies and helped with agitation, but it also caused issues like memory problems and heart rhythm changes. Other drugs, such as brexpiprazole, have been found safe and well-tolerated in trials, helping to reduce agitation.
Overall, non-drug methods are considered safer, while drug options can be effective but may carry risks. The trial aims to balance these treatments to improve care for those with Alzheimer's.12345Why are researchers excited about this trial?
Researchers are excited about the Integrated Care Pathway (ICP) for agitation in Alzheimer's disease because it offers a holistic approach that combines a cleanup phase, structured non-pharmacological interventions, and a targeted pharmacological phase. Unlike standard care, which often relies heavily on medications alone, the ICP starts with assessing and reducing unnecessary medications to minimize potential side effects. It then emphasizes non-drug strategies before introducing medication, providing a more balanced and potentially safer way to manage symptoms. This comprehensive method could lead to better overall outcomes and improve quality of life for patients with Alzheimer's-related agitation.
What evidence suggests that this trial's treatments could be effective for agitation in Alzheimer's disease?
This trial will compare an Integrated Care Pathway (ICP) with Treatment-As-Usual (TAU) for managing agitation in Alzheimer's disease. Research has shown that non-drug treatments, such as music therapy included in the ICP arm, can reduce restlessness in individuals with Alzheimer's, with studies indicating a moderate impact on calming agitation. In the ICP arm, these non-pharmacological interventions are structured and initiated before any pharmacological intervention. For medications, some drugs like Brexpiprazole, which may be part of the pharmacological intervention phase in the ICP arm, have been found to lessen agitation in Alzheimer's patients over a 12-week period. Medicines are often recommended when non-drug methods aren't sufficient or when there's a risk of harm. Together, these approaches offer promising ways to manage agitation in Alzheimer's disease.34567
Who Is on the Research Team?
Tarek Rajji, MD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for individuals aged 50 or older with Alzheimer's or Mixed type dementia experiencing aggression and agitation. Participants must be medically stable and have a decision maker able to consent. It excludes those with other significant mental health conditions like delirium, bipolar disorder, or major depression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Project Initiation
Initial setup and preparation for the trial across multiple sites
Screening
Participants are screened for eligibility to participate in the trial
Randomized Control Trial (RCT)
Participants are randomized to ICP or TAU and treated for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Non-Pharmacological Intervention
- Pharmacological Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
University of Calgary
Collaborator
Douglas Mental Health University Institute
Collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborator
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborator
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Collaborator
Lawson Health Research Institute
Collaborator