Antipsychotic Discontinuation in Alzheimer's Disease
Completed · Phase 4 · Has a placebo group
Conditions studied: Alzheimer Disease, Psychotic Disorders, Agitation, Aggression
In brief
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.
Key facts
- Study ID
- NCT00417482
- Run by
- New York State Psychiatric Institute
- People needed
- 180
- Starts
- 2004-08-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2013-04-24
Who can join
Age: 50 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Dementia, either sex, age 50-95 years
- Probable Alzheimer's disease
- Intellectual impairment present for at least 6 months
- Mini Mental State Exam (MMSE) score of 5-26 for outpatients and 2-26 for nursing home patients
- Availability of informant who has had direct contact with the patient for an average of at least once every week during the 3 months prior to study entry
- Meets Neuropsychiatric Inventory (NPI) criteria for either (1) psychosis, or (2) agitation/aggression
- Able to mobilize independently (if wheelchair-bound, the patient must be able to self-propel)
- Free of psychotropic medication (or able to tolerate washout) for at least 1 week prior to study entry. Low dose antidepressants and sedative/hypnotics allowed if they cannot be washed out and the dose remains stable for the study duration
- Expected to complete the study (including all efficacy evaluations) and be without major sensory impairment that would prevent participation in any aspect of the study
You may not qualify if…
- Current primary Axis I psychiatric disorder other than AD
- Substance abuse or dependence currently, or within the past year
- Dementia due to head trauma
- History of allergy to risperidone or intolerance to risperidone
- Diffuse Lewy body disease
- History of seizure disorder, infectious encephalitis, Parkinson's disease, central nervous system (CNS) neoplasm, tardive dyskinesia, stroke, transient ischemic attack (TIA) or uncontrolled atrial fibrillation
- Use of monoamine oxidase inhibitors (MAOIs) and unable to undergo 3-week washout; patients also may not take MAOIs for 2 weeks after completing the study
- In treatment with (a) depot antipsychotic within 2 weeks of the screening visit
- Untreated or incompletely treated hypothyroidism
- Active, unstable medical condition that requires active medication adjustment or surgery
- Need for electroconvulsive treatment (ECT)
- Significant risk for harm to themselves or others as a result of randomization to placebo
- History of malignant neoplasm during the last 5 years
Where it is running
- Tuscaloosa VA Medical Center, Department of Psychiatry — Tuscaloosa, Alabama, United States
- WLA VA Medical Center/UCLA, Psychiatry — Los Angeles, California, United States
- Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
- University of Iowa College of Medicine — Iowa City, Iowa, United States
- Mount Sinai School of Medicine, Alzheimer's Disease Research Center — New York, New York, United States
- New York State Psychiatric Institute, Columbia University — New York, New York, United States
- Medical University of South Carolina — North Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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