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New care pathway aims to tame agitation in Alzheimer's without overmedicating

NCT ID NCT03672201

Symptom relief Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a structured care pathway for treating agitation and aggression in people with Alzheimer's disease. The pathway combines personalized activities with medication guidelines to reduce symptoms and avoid using too many drugs. Researchers will compare this approach to usual care in 187 patients living in hospitals or long-term care facilities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integrated Care Pathway (ICP) combining behavioral activities and medication guidelines
What this could lead to
If successful, this could provide a standardized, effective approach to manage agitation and aggression in Alzheimer's, reducing reliance on multiple medications.
What could go wrong
This is a relatively small study (187 participants) and the intervention is complex, making it hard to isolate which part works. Results may not apply to all care settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

187 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Aggression Alzheimer disease dementia Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aggression Alzheimer dementia (AD) Alzheimer's disease

Contacts and locations

Locations

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4, Canada

  • Douglas Hospital Research Centre

    Montreal, Quebec, H4H 1R3, Canada

  • LAWSON Health Research Institute

    London, Ontario, N6C 2R5, Canada

  • Ontario Shores Centre for Mental Health Sciences

    Whitby, Ontario, L1N 5S9, Canada

  • Providence Care

    Kingston, Ontario, K7L 4X3, Canada

  • University of Calgary

    Calgary, Alberta, T2N 1N4, Canada

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