Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

NCT ID: NCT03672201

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

The Integrated Care Pathway (ICP) Arm

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 Type: ACTIVE_COMPARATOR

Non-Pharmacological Intervention

Intervention Type: BEHAVIORAL

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

Pharmacological Intervention

Intervention Type: 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.

Treatment-As-Usual (TAU) Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Behavioural Intervention

Eligibility Criteria

Inclusion Criteria

1. 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

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

3. Participant or substitute decision maker (SDM) able and willing to provide consent for enrollment in the study

4. 50 years or older

5. Medical stability to participate in the trial.

Exclusion Criteria

1. Having dementia other than Alzheimer's or Mixed type.

2. 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.

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Douglas Mental Health University Institute

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek Rajji, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

University of Calgary

Calgary, Alberta, Canada

Providence Care

Kingston, Ontario, Canada

LAWSON Health Research Institute

London, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, Canada

Douglas Hospital Research Centre

Montreal, Quebec, Canada

Countries

Canada

References

Choudhury S, Colman S; StaN Study Group; 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 2:1-20. doi: 10.1159/000548713. Online ahead of print.

Reference Type: DERIVED

PMID: 41037500 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40794901 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35147535 (View on PubMed)

Other Identifiers

1482

Identifier Type: -

Identifier Source: org_study_id