Antipsychotic Discontinuation in Alzheimer's Disease

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: Columbia University; National Institute on Aging (NIA)
• Treatments: Antipsychotic Agents; Risperidone

Criteria

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