Nctid:
NCT06234436
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000544", "term"=>"Alzheimer Disease"}, {"id"=>"D000060825", "term"=>"Cognitive Dysfunction"}], "ancestors"=>[{"id"=>"D000003704", "term"=>"Dementia"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000024801", "term"=>"Tauopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000003072", "term"=>"Cognition Disorders"}], "browseLeaves"=>[{"id"=>"M29705", "name"=>"Cognitive Dysfunction", "asFound"=>"Mild Cognitive Impairment", "relevance"=>"HIGH"}, {"id"=>"M3885", "name"=>"Alzheimer Disease", "asFound"=>"Alzheimer's Disease", "relevance"=>"HIGH"}, {"id"=>"M6904", "name"=>"Dementia", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M23002", "name"=>"Tauopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative 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"=>"M6301", "name"=>"Cognition Disorders", "relevance"=>"LOW"}, {"id"=>"T2192", "name"=>"Familial Alzheimer Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"This is a safety and feasibility study."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2023-12-07", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2023-12-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Change in DNA methylation age GrimAge2 from baseline", "timeFrame"=>"6 months", "description"=>"Epigenetic measurement"}, {"measure"=>"Proteomic profile", "timeFrame"=>"12 months", "description"=>"Comparison of the proteomic profile at baseline and the proteomic profile at 12 months. The profile will be measured using SomaLogic assays and in this endpoint the concentration of each protein at baseline will be compared to the concentration at 12 months."}, {"measure"=>"Single cell RNA seq", "timeFrame"=>"6 months"}, {"measure"=>"Change in EQ5D", "timeFrame"=>"12 months", "description"=>"The EQ5D questionnaire will be used"}], "primaryOutcomes"=>[{"measure"=>"Adverse events", "timeFrame"=>"Up to 4 years", "description"=>"Safety of the intervention in the patient group measured as number and severity of adverse events.\n\nThis will be evaluated as the number of participants with treatment-related adverse events as assessed by CTCAE v5.0."}], "secondaryOutcomes"=>[{"measure"=>"Change in Montreal Cognitive Assessment (MoCA) Test for Dementia", "timeFrame"=>"2 months", "description"=>"Change from baseline to after completion of all procedure cycles"}, {"measure"=>"Change in Montreal Cognitive Assessment (MoCA) Test for Dementia", "timeFrame"=>"6 months", "description"=>"Change from baseline to after the procedure"}, {"measure"=>"Change in Montreal Cognitive Assessment (MoCA) Test for Dementia", "timeFrame"=>"12 months", "description"=>"Change from baseline to after the procedure"}, {"measure"=>"Change in Montreal Cognitive Assessment (MoCA) Test for Dementia", "timeFrame"=>"24 months", "description"=>"Change from baseline to after the procedure"}, {"measure"=>"Change in Montreal Cognitive Assessment (MoCA) Test for Dementia", "timeFrame"=>"48 months", "description"=>"Change from baseline to after the procedure"}, {"measure"=>"Burden of participation questionnaire sum score", "timeFrame"=>"2 months", "description"=>"At the end of the procedure"}, {"measure"=>"Change in IL10 from baseline", "timeFrame"=>"2 months", "description"=>"Change in IL10"}, {"measure"=>"Change in IL10 from baseline", "timeFrame"=>"6 months", "description"=>"Change in IL10"}, {"measure"=>"Change in IL6 from baseline", "timeFrame"=>"2 months", "description"=>"Change in IL6"}, {"measure"=>"Change in IL6 from baseline", "timeFrame"=>"6 months", "description"=>"Change in IL6"}, {"measure"=>"Change in grip strength from baseline", "timeFrame"=>"2 months", "description"=>"Change in grip strength from baseline"}, {"measure"=>"Change in grip strength from baseline", "timeFrame"=>"6 months", "description"=>"Change in grip strength from baseline"}, {"measure"=>"Change in grip strength from baseline", "timeFrame"=>"12 months", "description"=>"Change in grip strength from baseline"}, {"measure"=>"Change in grip strength from baseline", "timeFrame"=>"24 months", "description"=>"Change in grip strength from baseline"}, {"measure"=>"Change in grip strength from baseline", "timeFrame"=>"48 months", "description"=>"Change in grip strength from baseline"}, {"measure"=>"Change in the CERAD 10-word test performance from baseline", "timeFrame"=>"2 months", "description"=>"Change in the CERAD 10-word test performance from baseline"}, {"measure"=>"Change in the CERAD 10-word test performance from baseline", "timeFrame"=>"6 months", "description"=>"Change in the CERAD 10-word test performance from baseline"}, {"measure"=>"Change in the CERAD 10-word test performance from baseline", "timeFrame"=>"12 months", "description"=>"Change in the CERAD 10-word test performance from baseline"}, {"measure"=>"Change in the CERAD 10-word test performance from baseline", "timeFrame"=>"24 months", "description"=>"Change in the CERAD 10-word test performance from baseline"}, {"measure"=>"Change in the CERAD 10-word test performance from baseline", "timeFrame"=>"48 months", "description"=>"Change in the CERAD 10-word test performance from baseline"}, {"measure"=>"Change in the trail making test A or B (as appropriate) time from baseline", "timeFrame"=>"2 months", "description"=>"Change in the trail making test A or B (as appropriate) time from baseline"}, {"measure"=>"Change in the trail making test A or B (as appropriate) time from baseline", "timeFrame"=>"6 months", "description"=>"Change in the trail making test A or B (as appropriate) time from baseline"}, {"measure"=>"Change in the trail making test A or B (as appropriate) time from baseline", "timeFrame"=>"12 months", "description"=>"Change in the trail making test A or B (as appropriate) time from baseline"}, {"measure"=>"Change in the trail making test A or B (as appropriate) time from baseline", "timeFrame"=>"24 months", "description"=>"Change in the trail making test A or B (as appropriate) time from baseline"}, {"measure"=>"Change in the trail making test A or B (as appropriate) time from baseline", "timeFrame"=>"48 months", "description"=>"Change in the trail making test A or B (as appropriate) time from baseline"}, {"measure"=>"Change in IQCODE from baseline", "timeFrame"=>"2 months", "description"=>"Measured at the nearest next-of-kin"}, {"measure"=>"Change in IQCODE from baseline", "timeFrame"=>"6 months", "description"=>"Measured at the nearest next-of-kin"}, {"measure"=>"Change in IQCODE from baseline", "timeFrame"=>"12 months", "description"=>"Measured at the nearest next-of-kin"}, {"measure"=>"Change in IQCODE from baseline", "timeFrame"=>"24 months", "description"=>"Measured at the nearest next-of-kin"}, {"measure"=>"Change in IQCODE from baseline", "timeFrame"=>"48 months", "description"=>"Measured at the nearest next-of-kin"}, {"measure"=>"Change in 4 meter walk test from baseline", "timeFrame"=>"2 months"}, {"measure"=>"Change in 4 meter walk test from baseline", "timeFrame"=>"6 months"}, {"measure"=>"Change in 4 meter walk test from baseline", "timeFrame"=>"12 months"}, {"measure"=>"Change in 4 meter walk test from baseline", "timeFrame"=>"24 months"}, {"measure"=>"Change in 4 meter walk test from baseline", "timeFrame"=>"48 months"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Alzheimer Disease"]}, "descriptionModule"=>{"briefSummary"=>"In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.", "detailedDescription"=>"Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nClinical diagnosis of Alzheimer's Disease\n\nMoCA score \\< 27 and \\>17\n\nAble to give informed consent as judged by the doctor setting the AD diagnosis and study doctor.\n\nAt least one biomarker of the AT(N)-classification system supporting the diagnosis\n\nExpected to live more than five years at inclusion by the study doctor.\n\nExclusion Criteria:\n\nKnown IgA deficiency\n\nKnown severe protein S depletion\n\nPrevious severe allergic reaction after transfusion of a blood product\n\nKnown heart failure\n\nKnown liver failure\n\nKnown kidney failure\n\nPrevious cancer \\<10 years.\n\nNot deemed able to participate by the study staff\n\nOther severe chronic diseases, interfering with the TPE-procedure\n\nOngoing infections\n\nOther unresolved medical conditions\n\nKnown coagulopathies\n\nFulfilling ICD-10 criteria for dementia at baseline, as evaluated by the evaluating physician.\n\nPeripheral veins not expected to be suitable for repeated venous access procedures."}, "identificationModule"=>{"nctId"=>"NCT06234436", "acronym"=>"ADDITION-MCI", "briefTitle"=>"Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)", "organization"=>{"class"=>"OTHER", "fullName"=>"Oslo University Hospital"}, "officialTitle"=>"Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)", "orgStudyIdInfo"=>{"id"=>"520697"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Plasma exchange", "description"=>"1-20 plasma exchanges.", "interventionNames"=>["Biological: Plasma exchenge"]}], "interventions"=>[{"name"=>"Plasma exchenge", "type"=>"BIOLOGICAL", "description"=>"Plasma exchange will be conducted. The substitution fluid will be plasma from ha healthy donor.", "armGroupLabels"=>["Plasma exchange"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"0450", "city"=>"Oslo", "country"=>"Norway", "facility"=>"Oslo University Hospital", "geoPoint"=>{"lat"=>59.91273, "lon"=>10.74609}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR", "ANALYTIC_CODE"], "timeFrame"=>"Before data analysis and publication", "ipdSharing"=>"YES", "description"=>"We will attempt to share IDP within the European GDPR rules.", "accessCriteria"=>"On request to the study contact."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Oslo University Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Impetus Grants (EIN: 87-1540960)", "class"=>"UNKNOWN"}, {"name"=>"Nasjonalforeningen for folkehelsen", "class"=>"UNKNOWN"}, {"name"=>"Vestre Viken Hospital Trust", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PI", "investigatorFullName"=>"Arne Vasli Lund Søraas", "investigatorAffiliation"=>"Oslo University Hospital"}}}}
