Integrated Care for Agitation in Alzheimer's Disease

(StaN Trial)

Recruiting at 5 trial locations

Overseen By Tarek Rajji, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Non-Alzheimer's dementia, Delirium, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

187 Participants Needed

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.

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 data supports the effectiveness of the treatment for agitation in Alzheimer's disease?

Research suggests that non-drug therapies, like personalized behavioral interventions, are effective in managing agitation in Alzheimer's patients. Additionally, antipsychotic drugs have the most evidence supporting their use, although non-drug approaches are recommended as the first option. ^{1 2 3 4 5}

Is the treatment for agitation in Alzheimer's disease safe?

Non-drug treatments for agitation in Alzheimer's are generally safe with few or no side effects. However, drug treatments, like antipsychotics, can have significant side effects and safety concerns, including increased risk of death. ^{1 6 7 8 9}

How is the Integrated Care for Agitation in Alzheimer's Disease treatment different from other treatments?

This treatment is unique because it combines both non-drug approaches, like environmental adjustments and personalized care, with drug treatments, offering a more comprehensive approach to managing agitation in Alzheimer's patients. Non-drug methods are usually the first choice, but this integrated approach can be more effective for some patients by addressing both behavioral and medical needs. ^{1 5 6 9 10}

Research Team

Tarek Rajji, MD

Principal Investigator

Centre for Addiction and Mental Health

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 or someone who makes decisions for me can agree to join the study.

I am medically stable enough to join the trial.

AD-AA as defined by Agitation in cognitive disorders; International Psychogeriatric Association provisional consensus clinical and research definition

Exclusion Criteria

Having dementia other than Alzheimer's or Mixed type

I have a mental health condition other than dementia affecting my Alzheimer's symptoms.

Any other reason which in the opinion of study investigator will make the study participation intolerable for the participant.

Timeline

Project Initiation

Initial setup and preparation for the trial across multiple sites

6 months

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Control Trial (RCT)

Participants are randomized to ICP or TAU and treated for 12 weeks

12 weeks

Visits at baseline, 3 weeks, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Non-Pharmacological Intervention
• Pharmacological Intervention

Trial Overview 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.

Participant Groups

Group I: The Integrated Care Pathway (ICP) Arm Active Control 2 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) Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Douglas Mental Health University Institute

Collaborator

Trials

31

Recruited

2,800+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Collaborator

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Collaborator

Trials

684

Recruited

432,000+

Findings from Research

A 6-month multimodal, nondrug therapy (motor stimulation, activities of daily living, and cognitive stimulation) significantly improved overall dementia symptoms in 130 nursing home residents with degenerative dementia, particularly enhancing social behavior and instrumental activities of daily living.

The intervention did not affect functional independence or total care time, suggesting that while it can alleviate some symptoms of dementia, it may not reduce the overall care needs of these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multimodal nondrug therapy on dementia symptoms and need for care in nursing home residents with degenerative dementia: a randomized-controlled study with 6-month follow-up. Luttenberger, K., Donath, C., Uter, W., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Environmental correlates of resident agitation in Alzheimer's disease special care units. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A real-world assessment of healthcare costs associated with agitation in Alzheimer's dementia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of multimodal nondrug therapy on dementia symptoms and need for care in nursing home residents with degenerative dementia: a randomized-controlled study with 6-month follow-up. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The Rationale and Design of Behavioral Interventions for Management of Agitation in Dementia in a Multi-Site Clinical Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Agitation and aggression in Alzheimer's disease: an update on pharmacological and psychosocial approaches to care. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Agitation and aggression in people with Alzheimer's disease. [2013]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Management of agitation in nursing home patients. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Progresses in treating agitation: a major clinical challenge in Alzheimer's disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A 2023 update on the advancements in the treatment of agitation in Alzheimer's disease. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Responding agitation in people with dementia. [2010]