Alzheimer's DiseaseStaNNCT03672201
Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
A study testing Non-Pharmacological Intervention and Pharmacological Intervention in people with Alzheimer's Disease and Alzheimer Dementia (AD), run by Centre for Addiction and Mental Health at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Alzheimer Dementia (AD), Aggression
- What is being tested?
- Non-Pharmacological Intervention and Pharmacological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Nov 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Calgary
Calgary, Alberta, T2N 1N4
Providence Care
Kingston, Ontario, K7L 4X3
LAWSON Health Research Institute
London, Ontario, N6C 2R5
Douglas Hospital Research Centre
Montreal, Quebec, H4H 1R3
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, L1N 5S9
About this study
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.
Read the 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
- Being tested
- Non-Pharmacological Intervention, Pharmacological Intervention
- Keywords
- Aggression, Agitation, Alzheimer's disease, Integrated Care Pathway, StaN, Dementia
- Medical subject headings
- Alzheimer Disease, Aggression, Psychomotor Agitation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Pharmacological InterventionBehavioural
Also called Behavioural Intervention
The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant.
Pharmacological InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks
Secondary outcomes (1)
The impact of the ICP on falls
Recording the number of falls
Measured: Every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Nov 2018
- Primary completion31 Mar 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Douglas Mental Health University Institute
- Responsible party
- Sponsor
- Investigators
- Tarek Rajji, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672201
- Sponsor's protocol ID
- 1482
- Acronym
- StaN
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41037500Tavakoli 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.
PubMed 40794901Zarei 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.
PubMed 35147535
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
- ClinicalTrials.gov ID
- NCT03672201
- Acronym / sponsor ID
- StaN / 1482
- Conditions
- Alzheimer's Disease, Alzheimer Dementia (AD), Aggression
- Keywords
- Aggression, Agitation, Alzheimer's disease, Integrated Care Pathway, StaN, Dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of Calgary, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Douglas Mental Health University Institute
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Integrated Care Pathway (ICP) Arm | Active comparator | Behavioral: Non-Pharmacological Intervention, Other: Pharmacological InterventionThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Pharmacological InterventionAlso: Behavioural InterventionThe behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant. | Behavioural | The Integrated Care Pathway (ICP) Arm |
| Pharmacological InterventionThe 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. | Other | The Integrated Care Pathway (ICP) Arm |
Primary outcome
Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency)
Time frame: Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks
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.
The proportion of participants on polypharmacy
Time frame: Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks
The percentage and the total number of participants on 2 or more psychotropics
1 secondary outcome
The impact of the ICP on falls
Time frame: Every 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41037500Choudhury 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.
- Derived from this study: PubMed 40794901Tavakoli 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.
- Derived from this study: PubMed 35147535Zarei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Rajji, MD principal investigator
Centre for Addiction and Mental Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Pharmacological Intervention and Pharmacological Intervention in people with Alzheimer's Disease and Alzheimer Dementia (AD), run by Centre for Addiction and Mental Health at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency) (time frame: Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.