Nctid:
NCT00000180
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008569", "term"=>"Memory Disorders"}], "ancestors"=>[{"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M29705", "name"=>"Cognitive Dysfunction", "relevance"=>"LOW"}, {"id"=>"M11552", "name"=>"Memory Disorders", "asFound"=>"Memory Disorders", "relevance"=>"HIGH"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11900", "name"=>"Mitogens", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2005-02", "completionDateStruct"=>{"date"=>"2005-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2009-12-10", "studyFirstSubmitDate"=>"1999-10-29", "studyFirstSubmitQcDate"=>"1999-10-29", "lastUpdatePostDateStruct"=>{"date"=>"2009-12-11", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-01", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Memory", "Mild cognitive impairment", "Nerve growth factors"], "conditions"=>["Memory Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"12770610", "type"=>"RESULT", "citation"=>"Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5."}]}, "descriptionModule"=>{"briefSummary"=>"AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.\n\nThis study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true}, "identificationModule"=>{"nctId"=>"NCT00000180", "briefTitle"=>"AIT-082 Phase 1B Study", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Aging (NIA)"}, "orgStudyIdInfo"=>{"id"=>"IA0008"}, "secondaryIdInfos"=>[{"id"=>"3U01AG010483-08S2", "link"=>"https://reporter.nih.gov/quickSearch/3U01AG010483-08S2", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"AIT-082", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92093-0949", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"University of California, San Diego", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana University Alzheimer's Center", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"48109-0322", "city"=>"Ann Arbor", "state"=>"Michigan", "country"=>"United States", "facility"=>"University of Michigan", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"63110", "city"=>"St. Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington University", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}], "overallOfficials"=>[{"name"=>"Michael Grundman, M.D., M.P.H.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of California, San Diego"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Aging (NIA)", "class"=>"NIH"}}}}
