Treatment of Behavioral Symptoms in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00009217|
Recruitment Status : Completed
First Posted : January 24, 2001
Last Update Posted : May 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Psychosis Agitation||Drug: Haloperidol-Haloperidol Drug: Haloperidol-Placebo||Phase 4|
The study involves two phases. Outpatients with AD who meet inclusion/ exclusion criteria enter Phase A, the 20 week open acute treatment phase that uses a flexible dose regimen of haloperidol 1-5 mg daily. Haloperidol is started at an oral dose of 1 mg daily, with subsequent dose titration in 1 mg increments until the optimal dose is reached, i.e., optimal trade-off between efficacy and side effects. At the end of Phase A, patients who do not meet criteria for clinical response exit the protocol and is treated openly with alternative medications.
Phase A responders enter Phase B, a 24-week random assignment, placebo-controlled, continuation trial. Randomization is stratified by the severity of dementia and by the presence of psychosis. Half the patients are randomized to haloperidol (continuing at the same dose as at the end of Phase A), and the other half are randomized to placebo. Patients who relapse during Phase B exit the protocol and receive open treatment.
In Phase A, patients are followed at 0, 2, 4 weeks and every 4 weeks thereafter until 20 weeks. In the discontinuation trial, Phase B, patients are followed at 0, 1, 2, 4, week time points and every 4 weeks thereafter until 24 weeks. If a patient shows signs of relapse, the patient is brought in for more frequent visits, regardless of the stage of the protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Behavioral Symptoms in Alzheimer's Disease|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
U.S. FDA Resources
Active Comparator: Haloperidol-Haloperidol
Haloperidol for 20 weeks followed by haloperidol for 24 weeks
Haloperidol open label flexible dose 1-5 mg daily for 20 weeks followed by haloperidol double-blind 1-5 mg for 24 weeks
Other Name: Haldol
Placebo Comparator: Haloperidol-Placebo
Haloperidol for 20 weeks followed by placebo for 24 weeks
Haloperidol open-label flexible dose of 1-5 mg for 20 weeks followed by placebo double-blind for 24 weeks
Other Name: Haldol
- For the primary hypothesis, the primary endpoint is time to relapse. [ Time Frame: 0-24 weeks in Phase B ]
- Severity of target symptoms at the end of Phase A as a predictor of relapse [ Time Frame: 0-24 weeks in Phase B ]
- Severity of Brief Psychiatric Rating Scale psychosis and hostile suspiciousness factor scores [ Time Frame: 0-20 weeks in Phase A and 0-24 weeks in Phase B ]
- MMSE and Blessed Functional Activity Scale [ Time Frame: 0-20 weeks in Phase A and 0-24 weeks in Phase B ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009217
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Davangere Devanand, M.D.||Columbia University College of Physicians and Surgeon|