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The antipsychotic discontinuation in Alzheimer disease trial: clinical rationale and study design


Devanand, D. P., Mintzer, Jacobo, Schultz, Susan, Sultzer, David, de la Pena, Danilo, Gupta, Sanjay, Colon, Sylvia, Schimming, Corbett, Pelton, Gregory H., Andrews, Howard, Levin, Bruce


The American Journal Of Geriatric Psychiatry: Official Journal Of The American Association For Geriatric Psychiatry, Volume: 20, No.: 4, Pages.: 362-373

Year of Publication



Objectives: : Research studies on the effects of discontinuing antipsychotic medications in patients with dementia have not identified specific target symptoms or response to antipsychotics prior to discontinuation. The Antipsychotic Discontinuation in Alzheimer Disease (ADAD) trial addresses these issues in a randomized, double-blind, placebo-controlled, multicenter risperidone treatment and discontinuation trial. In Phase A, AD patients with psychosis or agitation receive open treatment with risperidone for 16 weeks. Responders are randomized, double-blind, to one of three arms in Phase B: 1) continuation risperidone for the next 32 weeks, 2) risperidone for the next 16 weeks followed by placebo for 16 weeks, or 3) placebo for the next 32 weeks.; Methods: : Several design features provide unique strengths to this trial: identification of target symptoms and systematic open antipsychotic treatment with only responders randomized in the discontinuation trial, use of a single antipsychotic medication, two clinically relevant time-points for discontinuation to evaluate the impact of duration of treatment on relapse, exclusion of patients at increased risk of stroke, assessment of several affected symptom domains, and state-of-the-art approaches to assess relapse and handle dropout.; Conclusions: : This study will provide clinically relevant data on the likelihood and time to relapse, and predictors of relapse, in patients switched from risperidone to placebo after response to risperidone treatment. Given the warnings about antipsychotic use in patients with dementia, studies of this type are essential to determine the optimal duration of treatment that confers the greatest benefit to risk ratio and to improve evidence-based treatment strategies.;

Bibtex Citation

@article{Devanand_2012, doi = {10.1097/jgp.0b013e3182110563}, url = {}, year = 2012, month = {apr}, publisher = {Elsevier {BV}}, volume = {20}, number = {4}, pages = {362--373}, author = {D.P. Devanand and Jacobo Mintzer and Susan Schultz and David Sultzer and Danilo de la Pena and Sanjay Gupta and Sylvia Colon and Corbett Schimming and Gregory H. Pelton and Howard Andrews and Bruce Levin}, title = {The Antipsychotic Discontinuation in Alzheimer Disease Trial: Clinical Rationale and Study Design}, journal = {The American Journal of Geriatric Psychiatry} }


administration & dosage, agitation, alzheimer disease, and, antipsychotic agents, clinical protocols, complications, doubleblind method, drug therapy, humans, psychomotor agitation, psychosis, psychotic disorders, recurrence, research design, risperidone, therapeutic use, withholding treatment

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Antipsychotics and antidepressants