Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antipsychotic Discontinuation in Alzheimer's Disease
Brief 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.


Options:
A: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
B: Inclusion Criteria:

* Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion Criteria:

* Non-related legal surrogate without personal knowledge of resident
C: Inclusion Criteria:

* Outpatients
* diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
* living with or have regular and frequent visits from a responsible caregiver.

Exclusion Criteria:

* Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
* Any of specified conditions which may contribute to dementia
* any of specified coexisting diseases, including significant cardiovascular disease.
D: Inclusion Criteria:

* Diagnosis of dementia from Alzheimer's or other underlying cause
* Global Deterioration Scale (GDS) Stage 5, 6 or 7
* acute illness hospitalization

Exclusion Criteria:

* No English-speaking family decision-maker
* Primary physician expects study to be too stressful for family caregiver

Answer: A