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

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen ByTarek Rajji, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre for Addiction and Mental Health

No Placebo Group

Trial Summary

What is the purpose of this trial?The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF). The investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

Eligibility Criteria

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

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

I am 50 years old or older.

Participant Groups

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.

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.