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Could matching daily choices cut dementia agitation?

NCT ID NCT03577418

Symptom relief Sponsor: Mclean Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether a structured conversation between people with dementia or mild cognitive impairment and their care partners can reduce difficult symptoms like agitation and depression. The idea is that when care partners better understand the person's everyday preferences, unmet needs decrease, leading to fewer behavioral issues. The trial involves 20 pairs of participants and uses a clinician-facilitated tool to align their views.

What this could mean

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

Active substance
Templated, clinician-facilitated intervention to align everyday living preferences
What this could lead to
If successful, this approach could offer a safe, non-drug way to reduce distressing symptoms like agitation and depression in people with dementia.
What could go wrong
This is a small pilot study with only 20 pairs of participants, so results may not apply broadly. The intervention may not reduce symptoms as hoped.

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.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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

55 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.

Community-dwelling persons 55 years or older with a primary diagnosis of MCI or mild to moderate dementia will be eligible (Montreal Cognitive Assessment Score, MoCA, \> 10).24,25 PLWD/CI must have an identified care partner: a family member or close friend who knows the person well with contact at least three times/week. Informed consent will be obtained; if PLWD/CI are not able to provide informed consent, healthcare proxies will be asked to provide informed consent, with assent provided by PLWD/CI. The study clinician (board-certified geriatric psychiatrist) will be available to participants if unstable NPS develop during the study period. Participants must be fluent in written and oral English. PLWD/CI who are not experiencing any NPS at baseline (i.e., NPI-Q score of zero at baseline) will be excluded. PLWD/CI living in long-term care environments (e.g., nursing home, assisted living facility) will be excluded. Persons with comorbid active primary psychiatric illness (e.g., major depressive or bipolar mood disorders, psychotic disorders) will be excluded. We will recruit 20 dyads comprising PLWD/CI and the care partner.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction dementia

As listed by the trial registrant

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

Dementia Mild cognitive impairment

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.