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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00009217 |
Alzheimer's patients with behavioral problems (e.g., sleep disturbance, agitation) and/or psychosis are commonly treated with antipsychotic medications like haloperidol. This study focuses on the treatment of behavioral symptoms in Alzheimer's disease with haloperidol and whether long term treatment is necessary. The study is conducted in two phases: First, for five months active haloperidol is given, titrating the dose (1-4 mg. daily) for maximum effectiveness while closely monitoring side effects.
Second, for those patients who respond and remain stable on the medication, we examine whether continuation medication treatment is necessary. To this end, they are treated for another 24 weeks in a randomized double-blind placebo-controlled manner. After completing the study, patients are transferred back to their primary physician once the behavioral disturbance and/or psychosis is optimally treated.
Drs. D.P. Devanand and G. Pelton are conducting this project.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: Haloperidol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | R01 MH55735, IA0013, DSIR AT-GP |
Study First Received: | January 23, 2001 |
Last Updated: | November 29, 2005 |
ClinicalTrials.gov Identifier: | NCT00009217 |
Health Authority: | United States: Federal Government |
Behavioral symptoms |
Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Behavioral Symptoms Haloperidol |
Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Dementia Delirium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Antiemetics Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Tauopathies Central Nervous System Agents |