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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | OTHER |
| Douglas Mental Health University Institute | OTHER |
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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.
This project will take place in 7 sites across two settings: Inpatient (CAMH in Toronto, Douglas Hospital Research Centre in Montreal, Parkwood Institute in London, and the University of Calgary in Calgary); and LTCFs affiliated with CAMH in Toronto and Parkwood Institute in London.
After a project initiation phase of 6 months, the investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 in LTCFs) to ICP vs.TAU. In this randomized control trial (RCT) phase of the project, participants will be treated for 12 weeks. There will be two primary outcome measures: (i) the Cohen-Mansfield Agitation Inventory (CMAI) Total Frequency Score (CMAI-frequency) and (ii) the proportion of participants on polypharmacy. These measures will be conducted at baseline, end of non-pharmacological intervention phase, the mid-point of pharmacological interventions and end of RCT. Neuropsychiatric Inventory-Questionnaire (NPI-C) will be used to assess global burden of neuropsychiatric symptoms at baseline, end of non-pharmacological intervention phase and exit. The modified Clinical Global Impression of Change (CGIC) will also be measured at predetermined time points throughout the 12 weeks to determine response as defined by CGIC < 3. CGIC is a 7-point Likert scale to rate each patient along a continuum from marked improvement to marked worsening, based on global clinical impression. Rating of < 3 indicates moderate or marked improvement in agitation as compared to baseline. At the end of the RCT, each participant will be naturalistically followed up for an additional 6 months during which the investigators will collect both clinical and health economics data from the Institute for Clinical Evaluative Sciences (ICES) database. The RCT phase will be completed after 18 months, and during the last part of this project, the investigators will analyze the data from the RCT and complete all naturalistic follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Integrated Care Pathway (ICP) Arm | Active Comparator | 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. |
|
| Treatment-As-Usual (TAU) Arm | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Pharmacological Intervention | Behavioral | The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency) | The Cohen-Mansfield Agitation Inventory (CMAI) Frequency score measures burden of agitation in patients with dementia. CMAI-frequency score ranges between 29 to 203, higher scores indicate worsening of symptoms. | Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks |
| The proportion of participants on polypharmacy | The percentage and the total number of participants on 2 or more psychotropics | Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of the ICP on falls | Recording the number of falls | Every 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Rajji, MD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada | ||
| Providence Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41037500 | Derived | Choudhury S, Colman S, Chu L, Davies SJC, Derkach P, Elmi S, Fischer CE, Gerretsen P, Graff-Guerrero A, Hussain M, Ismail Z, Khan SS, Kim D, Krisman L, Moghabghab R, Mulsant BH, Nair V, Pollock BG, Rej S, Rostas A, Streiner D, Van Bussel L, Rajji TK, Kumar S, Burhan AM; StaN Study Group. Sex Differences in Phenomenology of Behavioral and Psychological Symptoms of Dementia. Neurodegener Dis. 2025 Oct 2:1-11. doi: 10.1159/000548713. Online ahead of print. | |
| 40794901 |
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Participants and assessors will be blind to the group assignment.
|
| Pharmacological Intervention | Other | 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. |
|
| Kingston |
| Ontario |
| K7L 4X3 |
| Canada |
| LAWSON Health Research Institute | London | Ontario | N6C 2R5 | Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
| Ontario Shores Centre for Mental Health Sciences | Whitby | Ontario | L1N 5S9 | Canada |
| Douglas Hospital Research Centre | Montreal | Quebec | H4H 1R3 | Canada |
| Derived |
| Tavakoli E, Niciforos E, Amid P, Cuperfain AB, Burhan AM, Colman S, Chu L, Davies SJC, Derkach P, Gerretsen P, Graff-Guerrero A, Hussain M, Ismail Z, Kim D, Krisman L, Mulsant BH, Pollock BG, Rej S, Rostas A, Rajji TK, Van Bussel L, Kumar S, Elmi S. The impact of lifetime excessive alcohol use on behavioural and psychological symptoms of dementia. Alcohol Alcohol. 2025 Jul 16;60(5):agaf048. doi: 10.1093/alcalc/agaf048. |
| 35147535 | Derived | Zarei S, Colman S, Rostas A, Burhan AM, Chu L, Davies SJ, Derkach P, Elmi S, Hussain M, Gerretsen P, Graff-Guerrero A, Ismail Z, Kim D, Krisman L, Moghabghab R, Mulsant BH, Nair V, Pollock BG, Rej S, Simmons J, Van Bussel L, Rajji TK, Kumar S; StaN Study Group. The Rationale and Design of Behavioral Interventions for Management of Agitation in Dementia in a Multi-Site Clinical Trial. J Alzheimers Dis. 2022;86(2):827-840. doi: 10.3233/JAD-215261. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000374 | Aggression |
| D011595 | Psychomotor Agitation |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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