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Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

NCT03672201

Active Not RecruitingNA

Sponsor: Centre for Addiction and Mental Health

Conditions: Alzheimer's Disease, Alzheimer Dementia (AD), Aggression

Interventions: Non-Pharmacological Intervention, Pharmacological Intervention

Countries: Canada

The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF). The investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (6)
  • Calgary, Alberta, Canada
  • Kingston, Ontario, Canada
  • London, Ontario, Canada
  • Toronto, Ontario, Canada
  • Whitby, Ontario, Canada
  • Montreal, Quebec, Canada