NCT03672201Active, not recruiting
Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 187 (actual)
- First submitted
- 13 Sept 2018
- Start date
- 1 Nov 2018
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Alzheimer disease
- NCT number
- NCT03672201
What you commit to
- Study type: Interventional
- Participants enrolled: 187
- From 1 Nov 2018 to the primary completion date, 31 Mar 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having dementia other than Alzheimer's or Mixed type.
- DSM-5 diagnoses other than dementia that is thought to be significantly impacting the presentation of AD-AA such as delirium, bipolar disorder, or major depressive disorder.
Other
- Any other reason which in the opinion of study investigator will make the study participation intolerable for the participant.
Who the study is looking for
- 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
- AD-AA as defined by Agitation in cognitive disorders; International Psychogeriatric Association provisional consensus clinical and research definition
- Participant or substitute decision maker (SDM) able and willing to provide consent for enrollment in the study
- 50 years or older
- Medical stability to participate in the trial.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Providence Care Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| LAWSON Health Research Institute Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Douglas Hospital Research Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Ontario Shores Centre for Mental Health Sciences Coordinator of this site? Confirm its status | Whitby | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.