Nctid:
NCT00000179
Payload:
{"FullStudy"=>{"Rank"=>493559, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"May 03, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000544", "ConditionMeshTerm"=>"Alzheimer Disease"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000003704", "ConditionAncestorTerm"=>"Dementia"}, {"ConditionAncestorId"=>"D000001927", "ConditionAncestorTerm"=>"Brain Diseases"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000024801", "ConditionAncestorTerm"=>"Tauopathies"}, {"ConditionAncestorId"=>"D000019636", "ConditionAncestorTerm"=>"Neurodegenerative Diseases"}, {"ConditionAncestorId"=>"D000019965", "ConditionAncestorTerm"=>"Neurocognitive Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3885", "ConditionBrowseLeafName"=>"Alzheimer Disease", "ConditionBrowseLeafAsFound"=>"Alzheimer's Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4818", "ConditionBrowseLeafName"=>"Behavioral Symptoms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14452", "ConditionBrowseLeafName"=>"Psychomotor Agitation", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6904", "ConditionBrowseLeafName"=>"Dementia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5204", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5742", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M23002", "ConditionBrowseLeafName"=>"Tauopathies", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21558", "ConditionBrowseLeafName"=>"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21836", "ConditionBrowseLeafName"=>"Neurocognitive Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2192", "ConditionBrowseLeafName"=>"Familial Alzheimer Disease", "ConditionBrowseLeafAsFound"=>"Alzheimer's Disease", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000006220", "InterventionMeshTerm"=>"Haloperidol"}, {"InterventionMeshId"=>"C000033563", "InterventionMeshTerm"=>"Haloperidol decanoate"}, {"InterventionMeshId"=>"D000014196", "InterventionMeshTerm"=>"Trazodone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000932", "InterventionAncestorTerm"=>"Antiemetics"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000005765", "InterventionAncestorTerm"=>"Gastrointestinal Agents"}, {"InterventionAncestorId"=>"D000014150", "InterventionAncestorTerm"=>"Antipsychotic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000018492", "InterventionAncestorTerm"=>"Dopamine Antagonists"}, {"InterventionAncestorId"=>"D000015259", "InterventionAncestorTerm"=>"Dopamine Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018726", "InterventionAncestorTerm"=>"Anti-Dyskinesia Agents"}, {"InterventionAncestorId"=>"D000014151", "InterventionAncestorTerm"=>"Anti-Anxiety Agents"}, {"InterventionAncestorId"=>"D000017367", "InterventionAncestorTerm"=>"Selective Serotonin Reuptake Inhibitors"}, {"InterventionAncestorId"=>"D000014179", "InterventionAncestorTerm"=>"Neurotransmitter Uptake Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000018687", "InterventionAncestorTerm"=>"Antidepressive Agents, Second-Generation"}, {"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9312", "InterventionBrowseLeafName"=>"Haloperidol", "InterventionBrowseLeafAsFound"=>"Every two weeks", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M215475", "InterventionBrowseLeafName"=>"Haloperidol decanoate", "InterventionBrowseLeafAsFound"=>"Every two weeks", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4247", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16950", "InterventionBrowseLeafName"=>"Trazodone", "InterventionBrowseLeafAsFound"=>"Tolerable", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M16904", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4251", "InterventionBrowseLeafName"=>"Antiemetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8881", "InterventionBrowseLeafName"=>"Gastrointestinal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14474", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7473", "InterventionBrowseLeafName"=>"Dopamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20596", "InterventionBrowseLeafName"=>"Dopamine Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17962", "InterventionBrowseLeafName"=>"Dopamine Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16905", "InterventionBrowseLeafName"=>"Anti-Anxiety Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19649", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Dyskinesia Agents", "InterventionBrowseBranchAbbrev"=>"AnDyAg"}, {"InterventionBrowseBranchName"=>"Antiemetics", "InterventionBrowseBranchAbbrev"=>"AnEm"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2005", "LastUpdateSubmitDate"=>"June 23, 2005", "StudyFirstSubmitDate"=>"October 29, 1999", "StudyFirstSubmitQCDate"=>"October 29, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 24, 2005", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 1, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Alzheimer's disease", "Psychomotor agitation", "Behavioral symptoms", "Haloperidol", "Trazodone", "Anti-psychotic agents", "Anti-depressant agents"]}, "ConditionList"=>{"Condition"=>["Alzheimer Disease"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11087767", "ReferenceType"=>"result", "ReferenceCitation"=>"Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in AD: a randomized, placebo-controlled clinical trial. Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271. Erratum In: Neurology 2001 Feb 13;56(3):426."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"http://www.alzheimers.org/", "SeeAlsoLinkLabel"=>"The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"50 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMemory problem consistent with a probable diagnosis of Alzheimer's disease (AD)\nAgitation symptoms for at least the past 2 weeks\nPatient has caregiver who can participate\nPatient lives in the same household as the caregiver"}, "IdentificationModule"=>{"NCTId"=>"NCT00000179", "BriefTitle"=>"Agitation in Alzheimer's Disease", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Aging (NIA)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"IA0003"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"3U01AG010483-08S2", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/3U01AG010483-08S2", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Trazodone", "InterventionType"=>"Drug"}, {"InterventionName"=>"Haloperidol", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"University of California, Los Angeles"}, {"LocationZip"=>"92093-0949", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"University of California, San Diego"}, {"LocationZip"=>"33140", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of Miami"}, {"LocationZip"=>"33162", "LocationCity"=>"Tampa", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of South Florida"}, {"LocationZip"=>"30329", "LocationCity"=>"Atlanta", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"Emory University"}, {"LocationZip"=>"62702", "LocationCity"=>"Springfield", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Southern Illinois University"}, {"LocationZip"=>"66160", "LocationCity"=>"Kansas City", "LocationState"=>"Kansas", "LocationCountry"=>"United States", "LocationFacility"=>"University of Kansas Medical Center"}, {"LocationZip"=>"40536", "LocationCity"=>"Lexington", "LocationState"=>"Kentucky", "LocationCountry"=>"United States", "LocationFacility"=>"University of Kentucky"}, {"LocationZip"=>"01665", "LocationCity"=>"Worcester", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"University of Massachusetts"}, {"LocationZip"=>"48109", "LocationCity"=>"Ann Arbor", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"University of Michigan"}, {"LocationZip"=>"55455", "LocationCity"=>"Minneapolis", "LocationState"=>"Minnesota", "LocationCountry"=>"United States", "LocationFacility"=>"University of Minnesota"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"New York University Medical Center"}, {"LocationZip"=>"10029", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Mount Sinai Medical Center"}, {"LocationZip"=>"14620", "LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"University of Rochester"}, {"LocationZip"=>"44120", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"University Hospitals of Cleveland"}, {"LocationZip"=>"97201-3098", "LocationCity"=>"Portland", "LocationState"=>"Oregon", "LocationCountry"=>"United States", "LocationFacility"=>"Oregon Health Sciences University"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Leon Thal, MD.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of California, San Diego"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Aging (NIA)", "LeadSponsorClass"=>"NIH"}}}}}}
