Status:
COMPLETED
Antipsychotic Discontinuation in Alzheimer's Disease
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Aging (NIA)
Columbia University
Conditions:
Alzheimer Disease
Psychotic Disorders
Eligibility:
All Genders
50-95 years
Phase:
PHASE4
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 p...
Detailed Description
This multicenter study (6 academic sites and 2 non-academic sites) involves treating AD patients (assisted living or nursing home patients, and outpatients) using an atypical antipsychotic, risperidon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00417482
Start Date
August 1 2004
End Date
April 1 2011
Last Update
April 24 2013
Active Locations (7)
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1
Tuscaloosa VA Medical Center, Department of Psychiatry
Tuscaloosa, Alabama, United States, 35404
2
WLA VA Medical Center/UCLA, Psychiatry
Los Angeles, California, United States, 90073
3
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
4
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242