Nctid:
NCT00002154
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003704", "term"=>"Dementia"}, {"id"=>"D060825", "term"=>"Cognitive Dysfunction"}, {"id"=>"D003072", "term"=>"Cognition Disorders"}], "ancestors"=>[{"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M6904", "name"=>"Dementia", "asFound"=>"Dementia", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M6301", "name"=>"Cognition Disorders", "asFound"=>"Cognitive Disorders", "relevance"=>"HIGH"}, {"id"=>"M18170", "name"=>"AIDS Dementia Complex", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M29705", "name"=>"Cognitive Dysfunction", "asFound"=>"Cognitive Disorders", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T247", "name"=>"AIDS Dementia Complex", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008063", "term"=>"Thioctic Acid"}, {"id"=>"D012642", "term"=>"Selegiline"}], "ancestors"=>[{"id"=>"D000928", "term"=>"Antidepressive Agents"}, {"id"=>"D011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000978", "term"=>"Antiparkinson Agents"}, {"id"=>"D018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D008996", "term"=>"Monoamine Oxidase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018696", "term"=>"Neuroprotective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000975", "term"=>"Antioxidants"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}], "browseLeaves"=>[{"id"=>"M11063", "name"=>"Thioctic Acid", "asFound"=>"CVL-", "relevance"=>"HIGH"}, {"id"=>"M15454", "name"=>"Selegiline", "asFound"=>"Thailand", "relevance"=>"HIGH"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M4295", "name"=>"Antiparkinson Agents", "relevance"=>"LOW"}, {"id"=>"M11960", "name"=>"Monoamine Oxidase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20773", "name"=>"Neuroprotective Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T359", "name"=>"Alpha-lipoic Acid", "asFound"=>"CVL-", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>32}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-03", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Drug Therapy, Combination", "Cognition Disorders", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Thioctic Acid", "Selegiline"], "conditions"=>["Cognitive Disorders", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).", "detailedDescription"=>"Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.\n\nPatients must have:\n\n* HIV seropositivity.\n* Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).\n* No active opportunistic CNS infection.\n* Ability to give informed consent.\n\nPrior Medication:\n\nAllowed:\n\n* Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.\n* Prior thioctic acid or deprenyl.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.\n* CNS neoplasms.\n* Any other clinically significant condition or laboratory abnormality that would preclude participation on study.\n* Current participation in other drug studies.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemotherapy for malignancy.\n\nPatients with the following prior conditions are excluded:\n\n* History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.\n* Prior participation in this study.\n* History of adverse reaction/allergy to thioctic acid or deprenyl.\n\nPrior Medication:\n\nExcluded:\n\n* Other investigational drugs within 30 days prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002154", "briefTitle"=>"A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia", "orgStudyIdInfo"=>{"id"=>"250A"}, "secondaryIdInfos"=>[{"id"=>"03-D95"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Thioctic acid", "type"=>"DRUG"}, {"name"=>"Selegiline hydrochloride", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"212876965", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia Univ", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Med Ctr", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Dana Foundation", "class"=>"OTHER"}}}}