Treatment of Behavioral Symptoms in Alzheimer's Disease
2 other identifiers
interventional
44
1 country
1
Brief Summary
The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 1999
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1999
CompletedFirst Submitted
Initial submission to the registry
January 23, 2001
CompletedFirst Posted
Study publicly available on registry
January 24, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedMay 24, 2016
February 1, 2012
5.9 years
January 23, 2001
May 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
For the primary hypothesis, the primary endpoint is time to relapse.
0-24 weeks in Phase B
Secondary Outcomes (3)
Severity of target symptoms at the end of Phase A as a predictor of relapse
0-24 weeks in Phase B
Severity of Brief Psychiatric Rating Scale psychosis and hostile suspiciousness factor scores
0-20 weeks in Phase A and 0-24 weeks in Phase B
MMSE and Blessed Functional Activity Scale
0-20 weeks in Phase A and 0-24 weeks in Phase B
Study Arms (2)
Haloperidol-Haloperidol
ACTIVE COMPARATORHaloperidol for 20 weeks followed by haloperidol for 24 weeks
Haloperidol-Placebo
PLACEBO COMPARATORHaloperidol for 20 weeks followed by placebo for 24 weeks
Interventions
Haloperidol open label flexible dose 1-5 mg daily for 20 weeks followed by haloperidol double-blind 1-5 mg for 24 weeks
Haloperidol open-label flexible dose of 1-5 mg for 20 weeks followed by placebo double-blind for 24 weeks
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for dementia either sex, age 50-95 years
- Meets NINCDS-ADRDA criteria for probable Alzheimer's disease
- Meets Folstein Mini-Mental State Exam score of 5-26, inclusive
- Intellectual impairment reported for at least six months
- Availability of family member who has had direct contact with the patient for an average of at least once every week during the three months prior to study entry
- Has current symptoms of psychosis or agitation. Criteria for "psychosis" requires the presence of delusions and/or hallucinations identified by the Columbia University Scale for Psychopathology in Alzheimer's Disease (CUSPAD) and a minimum Brief Psychiatric Rating Scale (BPRS) psychosis factor score of at least 4 (moderate severity) on one of the following two items: These two items comprise the psychosis factor, excluding the item for conceptual disorganization. Agitation is defined as a score of greater than 3 (present at least 10 days per month) on one or more of the CERAD Behavioral Rating Scale for Dementia items for agitation, purposeless wandering, verbal aggression or physical aggression.
- Free of psychotropic medication for at least two weeks prior to study entry, or able to tolerate medication washout for this period.
- Informed consent by patient and family member, as per IRB procedures at New York State Psychiatric Institute.
You may not qualify if:
- Acute unstable medical condition, delirium, alcohol or substance abuse or dependence within the past 1 year
- Clinical evidence of stroke, other dementias including vascular or Lewy body or frontotemporal dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, tardive dyskinesia
- Diagnosis of a psychotic disorder antedating the onset of dementia
- Antipsychotic medication usage during 4 weeks prior to study entry
- Contraindication to the use of haloperidol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Devanand DP, Pelton GH, Cunqueiro K, Sackeim HA, Marder K. A 6-month, randomized, double-blind, placebo-controlled pilot discontinuation trial following response to haloperidol treatment of psychosis and agitation in Alzheimer's disease. Int J Geriatr Psychiatry. 2011 Sep;26(9):937-43. doi: 10.1002/gps.2630. Epub 2010 Dec 28.
PMID: 21845596RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Davangere Devanand, M.D.
Columbia University College of Physicians and Surgeon
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2001
First Posted
January 24, 2001
Study Start
January 1, 1999
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
May 24, 2016
Record last verified: 2012-02