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Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

NCT03672201 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Non-Pharmacological Intervention

The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant.

OTHER

Pharmacological Intervention

The medication algorithm provides recommendations to the treatment team about algorithmic treatment and assessments as per the ICP but ultimately the decision to prescribe any particular intervention will be the treatment team's decision and the recommendations of the research team for ICP arm will not be binding for the treatment team.

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

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

    collaborator OTHER

  • Douglas Mental Health University Institute

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Tarek Rajji, MD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2023-03-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672201 on ClinicalTrials.gov