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Intervention for Dementia

N/A
Waitlist Available
Led By Henry YH Siu, MSc, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

Aggressive behaviours in long-term care (LTC) is a difficult health care issue to manage. One method that has been over-used is the prescription of antipsychotics for the behaviours and psychological symptoms of dementia (BPSD). This high prevalence of use is a recognized health care problem in Ontario and around the world; increased antipsychotics use is associated with increased falls and mortality. Existing strategies are educational in nature and are not systematic; the goal of this study is to develop a systematic algorithm to help LTC physicians deprescribe and taper antipsychotics safely and effectively. The objectives of the study is to: 1) Develop a discontinuation algorithm for antipsychotics based on single patient open-label (SPOT) trial methodology (e.g. a variation of N-of-1 trials) with standardized outcome measures for LTC physicians; 2) To pilot a clinical pharmacist-led recruitment strategy; 3) To provide preliminary evidence to demonstrate that this algorithm could lead to deprescribing of anti-psychotic medications in LTC.

Eligible Conditions
  • Dementia
  • Behavior

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decision on antipsychotic dose at the end of the 12-week trial
Secondary outcome measures
Evidence for implementation in Long-Term Care
Frequency of "as needed" doses used
Frequency of falls
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
The intervention consists of assigning each participant to their own single patient open label trial consisting of a 1:1 randomized sequence of two pre-determined dose reductions of atypical antipsychotics for each participant in order to determine any behavioural issues that arise from atypical antipsychotic dose alteration.

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
885 Previous Clinical Trials
2,598,323 Total Patients Enrolled
7 Trials studying Dementia
900,883 Patients Enrolled for Dementia
College of Family Physicians of CanadaOTHER
7 Previous Clinical Trials
9,798 Total Patients Enrolled
MediSystem PharmacyUNKNOWN

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~2 spots leftby May 2025