← Back to Search

Integrated Care for Agitation in Alzheimer's Disease (StaN Trial)

N/A

Waitlist Available

Led By Tarek Rajji, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A clinical diagnosis of Dementia of Alzheimer's or Mixed type using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) criteria

50 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up conducted at baseline, 3 weeks, 8 weeks, and 12 weeks

Awards & highlights

StaN Trial Summary

This trialwill study an Integrated Care Pathway to treat aggression & agitation in Alzheimer's, using psychotropic medications & non-pharmacological interventions, to assess its efficacy, impact on inappropriate medication use, & caregiver burden.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests an Integrated Care Pathway (ICP) against usual treatment for managing aggression and agitation in Alzheimer's disease. The ICP combines medication use and non-drug approaches based on standardized assessments in a randomized trial involving 220 participants.See study design

What are the potential side effects?

While specific side effects are not listed, the pharmacological interventions may include typical drug-related risks such as dizziness, gastrointestinal issues, mood changes, or increased confusion which will be monitored throughout the study.

StaN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Alzheimer's or Mixed Dementia.

Select...

I am 50 years old or older.

StaN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ conducted at baseline, 3 weeks, 8 weeks, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~conducted at baseline, 3 weeks, 8 weeks, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and conducted at baseline, 3 weeks, 8 weeks, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency)

The proportion of participants on polypharmacy

Secondary outcome measures

The impact of the ICP on falls

StaN Trial Design

2Treatment groups

Active Control

Group I: The Integrated Care Pathway (ICP) ArmActive Control2 Interventions

The ICP consists of 1) a cleanup phase during which a thorough assessment of pharmacotherapy to discontinue unnecessary medications, is performed; 2) Structured non-pharmacological interventions, which would have started as soon as randomization occurred and would continue before any pharmacological intervention for 2 weeks as stand-alone interventions; and 3) a pharmacological intervention phase: in this phase the medications algorithm for AD-AA is initiated.

Group II: Treatment-As-Usual (TAU) ArmActive Control1 Intervention

Following eligibility and baseline assessments, half of the participants will be randomized to TAU. TAU will consist of the typical care that the interdisciplinary team provides at each site for AD-AA. No predetermined cleanup phase, non-pharmacological interventions, algorithmic pharmacological interventions will be systematically part of TAU.

0 / 2Eligibility criteria met