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Could a doll ease dementia symptoms? new study tests a simple, Drug-Free approach

NCT ID NCT06506487

Symptom relief Sponsor: University of Malaya 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether giving people with dementia a lifelike doll to care for can reduce their need for medications like antipsychotics and improve their mood and behavior. The trial involves 142 residents aged 65 and older across six nursing homes in China, comparing those who receive doll therapy plus usual care with those who receive usual care alone. Researchers will track medication use, behavioral symptoms, and daily function over 12 weeks, and interview staff and families about how well the approach works in practice.

What this could mean

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

Active substance
doll therapy
What this could lead to
If effective, this simple, non-drug approach could reduce reliance on antipsychotics and other medications for dementia-related symptoms in nursing homes.
What could go wrong
This is a small pilot study, so results may not be conclusive. The therapy may not work for all residents, and cultural acceptance in Chinese care settings is still being explored.

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

142 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2025

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

65 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: * Age 65 years or older. * Nursing home resident with a documented clinical diagnosis of dementia recorded in the medical or nursing-home record by a qualified physician using DSM-5, ICD-10, ICD-11, or current Chinese clinical guidelines for dementia and cognitive impairment; where the underlying diagnostic criteria were not specified in the record, the site clinician reconfirmed the diagnosis against DSM-5 criteria before enrollment. * Adequate visual capacity to recognize a doll at screening. * Sufficient upper-limb function to hold or caress the doll safely. * Availability of a legally authorized representative able to provide written informed consent. * Resident assent whenever appropriate. Exclusion Criteria: * Acute medical instability. * Severe sensory or physical limitations preventing safe participation. * Severe communication impairment precluding meaningful participation. * Major psychiatric disorders unrelated to dementia. * Resident dissent or refusal when assent was appropriate, or safety concerns that made doll interaction unsuitable.

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Conditions

The condition(s) this trial relates to.

dementia

As listed by the trial registrant

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

Dementia

Contacts and locations

Locations

  • Sias University

    Zhengzhou, Henan, 451100, China

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