NCT03672201 · ACTIVE NOT RECRUITING

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

This trial is testing a structured care plan called an Integrated Care Pathway to manage aggression and agitation in people who already have Alzheimer's dementia. The pathway guides clinicians through both medication and non-drug options based on standardized assessments. It is a Phase NA pragmatic trial — meaning it is evaluating how well a care protocol works in real clinical settings like hospitals and long-term care facilities, not testing a new drug for approval.

You may qualify if

  • 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.

You're excluded if

  • 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.

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 2026-04-13

View full record on ClinicalTrials.gov

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