Antipsychotic Discontinuation in Alzheimer's Disease
Summary
In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.
Timeline
- Start
- 2004-08
- Primary completion
- 2011-04
- Completion
- 2011-04
Outcome
Met primary endpoint
paper the rate of relapse was higher in the group that received placebo than in the groups that received risperidone PMID 23075176 ↗
paper 60% [24 of 40 patients in group 3] vs. 33% [23 of 70 in groups 1 and 2]; P=0.004 PMID 23075176 ↗
Publications
- Results Devanand DP, Mintzer J, Schultz SK, Andrews HF, Sultzer DL, de la Pena D, Gupta S, Colon S, Schimming C, Pelton GH, Levin B. Relapse risk after discontinuation of risperidone in Alzheimer's disease. N Engl J Med. 2012 Oct 18;367(16):1497-507. doi: 10.1056/NEJMoa1114058.
- Patel AN, Lee S, Andrews HF, Pelton GH, Schultz SK, Sultzer DL, Mintzer J, de la Pena D, Gupta S, Colon S, Schimming C, Levin B, Devanand DP. Prediction of Relapse After Discontinuation of Antipsychotic Treatment in Alzheimer's Disease: The Role of Hallucinations. Am J Psychiatry. 2017 Apr 1;174(4):362-369. doi: 10.1176/appi.ajp.2016.16020226. Epub 2016 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 0.25 mg | — |
| Subject | Risperidone | Other / unclassified | 3 mg | — |