Virtual Reality to Advance Dementia Care and Quality of Life

Eligibility criteria

Inclusion Criteria:
1. Adults aged 55 years or older.
2. Diagnosis of Major Neurocognitive Disorder due to Alzheimer's disease or mixed/multiple etiologies (e.g., Alzheimer's disease with vascular contributions), based on DSM-5-TR criteria and documented clinical diagnosis.
3. Moderate-to-severe dementia, based on documented clinical diagnosis, clinical assessment, or available medical record information.
4. Presence of clinically significant agitation meeting the 2024 International Psychogeriatric Association (IPA) consensus clinical and research definition of agitation in cognitive disorders, as determined by the investigator using the CMAI together with other relevant clinical information. The prospective participant must:
   * demonstrate excessive motor activity, verbal aggression, and/or physical aggression associated with observed or inferred evidence of emotional distress;
   * have behaviours that have been persistent or frequently recurrent for at least two weeks, or that represent a dramatic change from the prospective participant's usual behaviour;
   * have behaviours that are severe and associated with excess distress or produce excess disability beyond that attributable to the cognitive impairment, including significant impairment in interpersonal relationships, other aspects of social functioning, or the ability to perform or participate in activities of daily living; and
   * have agitation that is not attributable solely to another psychiatric disorder, medical condition-including delirium-suboptimal care conditions, or the physiological effects of a substance or medication.
   The CMAI will be used to document the nature and frequency of relevant agitated behaviours during the preceding two weeks and to support the investigator's determination of whether the participant meets the 2024 IPA definition. CMAI scores alone will not establish eligibility.
5. Admitted to one of the participating inpatient geriatric psychiatry units and considered by the treating team to be clinically appropriate for participation in a brief, seated, supervised VR intervention.
6. Expected by the treating team to remain admitted long enough to participate in at least some study procedures. Participants with uncertain discharge timing may still be considered eligible, and early discharge will be documented as part of feasibility and participant disposition outcomes.
7. Availability of a Substitute Decision-Maker (SDM) able to provide informed consent, when the participant is not capable of providing consent.
8. Participant able to provide assent when feasible or demonstrate behavioural willingness to participate, as assessed by the clinical and/or research team. Participants who verbally or non-verbally refuse participation, or who demonstrate distress or unwillingness, will not proceed with study procedures unless willingness is later re-established.
9. Availability of an appropriate respondent or information source, such as clinical staff familiar with the participant, SDM, family member, or care partner, to support completion of study assessments when required.
Exclusion Criteria:
1. Severe visual impairment that would prevent safe or meaningful engagement with the VR headset.
2. Active delirium at screening.
3. Clinically significant delusions and/or hallucinations that may increase the risk of distress during VR exposure, including NPI-NH delusion and/or hallucination subscale score ≥4, or clinical equivalent based on treating team assessment.
4. Uncontrolled seizure disorder.
5. Major psychotropic medication change within 7 days prior to enrollment that, in the opinion of the investigator or treating team, would substantially confound baseline agitation assessment or make participation clinically inappropriate.
6. Any medical, psychiatric, behavioural, sensory, or safety-related condition that, in the opinion of the treating team or study investigators, would make participation unsafe or not clinically appropriate.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-10-26