Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

NCT03672201 | Active Not Recruiting DMC

• 1 other identifier: 1482
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 6

Brief 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

Alzheimer's Disease; Aggression; Alzheimer Dementia (AD)

Keywords

Aggression; Agitation; Alzheimer's disease; Integrated Care Pathway; StaN; Dementia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• The impact of the ICP on falls

  Every 2 weeks

Study Arms (2)

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.

Behavioral: Non-Pharmacological Intervention; Other: Pharmacological Intervention

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.

Interventions

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.

Also known as: Behavioural Intervention

The Integrated Care Pathway (ICP) Arm

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.

The Integrated Care Pathway (ICP) Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Medical stability to participate in the trial.

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of Calgary: collaborator
• Douglas Mental Health University Institute: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (6)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Providence Care

Kingston, Ontario, K7L 4X3, Canada

Location

LAWSON Health Research Institute

London, Ontario, N6C 2R5, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

Location

Douglas Hospital Research Centre

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (3)

• 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.

  PMID: 41037500 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.

  PMID: 40794901 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.

  PMID: 35147535 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Aggression; Psychomotor Agitation; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarek Rajji, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and assessors will be blind to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: November 1, 2018
• Primary Completion: March 31, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)