{"protocolSection":{"identificationModule":{"nctId":"NCT03272711","orgStudyIdInfo":{"id":"201509107"},"organization":{"fullName":"Washington University School of Medicine","class":"OTHER"},"briefTitle":"Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training","officialTitle":"Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training","acronym":"BBS"},"statusModule":{"statusVerifiedDate":"2019-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-08-31","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-01-24","type":"ACTUAL"},"completionDateStruct":{"date":"2019-01-24","type":"ACTUAL"},"studyFirstSubmitDate":"2017-09-01","studyFirstSubmitQcDate":"2017-09-01","studyFirstPostDateStruct":{"date":"2017-09-05","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-12-02","resultsFirstSubmitQcDate":"2019-12-27","resultsFirstPostDateStruct":{"date":"2020-01-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-12-27","lastUpdatePostDateStruct":{"date":"2020-01-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Washington University School of Medicine","class":"OTHER"},"collaborators":[{"name":"Queen's University","class":"OTHER"},{"name":"Takeda","class":"INDUSTRY"}]},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.","detailedDescription":"The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.\n\nVortioxetine is considered investigational when used as a treatment for age-related cognitive decline, which means that it has not been approved by the U.S. Food and Drug Administration for this purpose. Vortioxetine is approved by the U.S. Food and Drug Administration as a treatment for depression, and also goes by the name Trintellix (formerly known as Brintellix). That means that, while the drug itself is approved by the FDA, it is not approved for the reasons the investigators are using it in this study.\n\nParticipation in this study entails an estimated 6 study visits over the course of approximately six months. Participants will complete various assessments at our lab at the Washington University School of Medicine along with check-in visits in-person or over the phone. Additionally, they will participate in at home computerized cognitive training for approximately six months, supplemented with either vortioxetine or placebo.\n\nThe investigators will assess memory and problem-solving abilities using paper and pencil, computerized measures, and self-assessments of how participants feel. These tests could include numbers, letters, symbols, words, or sentences. These tests will be repeated throughout the study. If eligible to do so, participants will complete a baseline MRI scan.\n\nA subset of participants who completed a baseline MRI scan will complete another MRI scan after approximately 26 weeks of vortioxetine or placebo and at home computerized cognitive training."},"conditionsModule":{"conditions":["Age-related Cognitive Decline"],"keywords":["Vortioxetine","Elderly","Online cognitive training"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":129,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine plus cognitive training","type":"EXPERIMENTAL","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day","interventionNames":["Drug: Vortioxetine 10 mg","Behavioral: Cognitive training program"]},{"label":"Placebo plus cognitive training","type":"PLACEBO_COMPARATOR","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day","interventionNames":["Behavioral: Cognitive training program"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine 10 mg","armGroupLabels":["Vortioxetine plus cognitive training"],"otherNames":["Trintellix"]},{"type":"BEHAVIORAL","name":"Cognitive training program","description":"Online training program, 30 minutes a day, 5 times a week","armGroupLabels":["Placebo plus cognitive training","Vortioxetine plus cognitive training"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Total Fluid Cognitive Score","description":"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured \"fluid\" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.","timeFrame":"Randomization (0 weeks), 4 weeks"}],"secondaryOutcomes":[{"measure":"Change in Total Fluid Cognitive Score","description":"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured \"fluid\" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.","timeFrame":"Randomization (0 weeks), 4 week, 12 week, 26 week"},{"measure":"Participant Function","description":"Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).\n\nA validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100.","timeFrame":"Randomization (0 weeks), 26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Community-living men and women age 65 and older\n* Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction that is attributed to the aging process (in response to screening questions to the participant); (b) ability to complete cognitive battery, but still scoring less than 1 standard deviation above age-matched norms at both baseline and after the two-week cognitive training lead-in.\n\nExclusion Criteria:\n\n* Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease) per self-report, informant report, medical records, or neuropsychological testing\n* Any current psychiatric disorder\n* Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or with the assessments.\n* Sensory impairment that would prevent participation\n* IQ \\< 70 as estimated by the Wechsler Test of Adult Reading\n* Alcohol or substance abuse within 6 months\n* Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity\n* Psychotropic medications or those with likely CNS effects (none within 4 weeks prior to study entry)","healthyVolunteers":true,"sex":"ALL","minimumAge":"65 Years","stdAges":["OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eric Lenze, MD","affiliation":"Washington University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","zip":"63110","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}}]},"referencesModule":{"references":[{"pmid":"12425704","type":"BACKGROUND","citation":"Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271."},{"pmid":"23896849","type":"BACKGROUND","citation":"Bowie CR, Gupta M, Holshausen K, Jokic R, Best M, Milev R. Cognitive remediation for treatment-resistant depression: effects on cognition and functioning and the role of online homework. J Nerv Ment Dis. 2013 Aug;201(8):680-5. doi: 10.1097/NMD.0b013e31829c5030."},{"pmid":"23484795","type":"BACKGROUND","citation":"Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. N Engl J Med. 2013 Mar 28;368(13):1169-71. doi: 10.1056/NEJMp1302513. Epub 2013 Mar 13. No abstract available."},{"pmid":"25405755","type":"BACKGROUND","citation":"Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov."},{"pmid":"32212856","type":"DERIVED","citation":"Lenze EJ, Stevens A, Waring JD, Pham VT, Haddad R, Shimony J, Miller JP, Bowie CR. Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial. Am J Psychiatry. 2020 Jun 1;177(6):548-555. doi: 10.1176/appi.ajp.2019.19050561. Epub 2020 Mar 26."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Twenty-nine participants were not assigned to a group. Twenty did not meet eligibility criteria for randomization, 8 individuals declined to participate further and one person was a pilot participant.","groups":[{"id":"FG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"FG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"41"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"BG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"100"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"71.68","spread":"4.77"},{"groupId":"BG001","value":"71.88","spread":"5.3"},{"groupId":"BG002","value":"71.78","spread":"5.01"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"51"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"49"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"98"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"78"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"100"}]}]}]},{"title":"Years of Schooling","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.80","spread":"2.48"},{"groupId":"BG001","value":"16.63","spread":"3.24"},{"groupId":"BG002","value":"16.72","spread":"2.87"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Total Fluid Cognitive Score","description":"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured \"fluid\" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Randomization (0 weeks), 4 weeks","groups":[{"id":"OG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"OG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"classes":[{"title":"Change in Total Fluid Cognitive Score","categories":[{"measurements":[{"groupId":"OG000","value":"6.14","spread":"7.80"},{"groupId":"OG001","value":"3.71","spread":"7.27"}]}]},{"title":"Week 4 Total Fluid Cogntive Score","categories":[{"measurements":[{"groupId":"OG000","value":"106.06","spread":"17.06"},{"groupId":"OG001","value":"105.85","spread":"12.38"}]}]}]},{"type":"SECONDARY","title":"Change in Total Fluid Cognitive Score","description":"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured \"fluid\" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Randomization (0 weeks), 4 week, 12 week, 26 week","groups":[{"id":"OG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"OG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"classes":[{"title":"Change at Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"6.14","spread":"7.8"},{"groupId":"OG001","value":"3.71","spread":"7.27"}]}]},{"title":"Change at Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"8.24","spread":"7.82"},{"groupId":"OG001","value":"3.93","spread":"6.70"}]}]},{"title":"Change at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"7.55","spread":"7.95"},{"groupId":"OG001","value":"6.05","spread":"8.26"}]}]},{"title":"Total Fluid Cognitive Score at Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"106.06","spread":"17.06"},{"groupId":"OG001","value":"105.85","spread":"12.38"}]}]},{"title":"Total Fluid Cognitive Score at Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"108.12","spread":"16.34"},{"groupId":"OG001","value":"105.57","spread":"12.31"}]}]},{"title":"Total Fluid Cognitive Score at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"106.98","spread":"17.19"},{"groupId":"OG001","value":"107.51","spread":"11.44"}]}]}]},{"type":"SECONDARY","title":"Participant Function","description":"Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).\n\nA validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Randomization (0 weeks), 26 weeks","groups":[{"id":"OG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"},{"id":"OG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"classes":[{"title":"Change in UPSA Score","categories":[{"measurements":[{"groupId":"OG000","value":"2.91","spread":"7.26"},{"groupId":"OG001","value":"1.66","spread":"8.73"}]}]},{"title":"Total UPSA Score at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"84.50","spread":"8.80"},{"groupId":"OG001","value":"82.44","spread":"8.59"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"26 weeks","eventGroups":[{"id":"EG000","title":"Vortioxetine Plus Cognitive Training","description":"Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day\n\nVortioxetine 10 mg\n\nCognitive training program: Online training program, 30 minutes a day, 5 times a week","deathsNumAffected":0,"deathsNumAtRisk":51,"seriousNumAffected":0,"seriousNumAtRisk":51,"otherNumAffected":31,"otherNumAtRisk":51},{"id":"EG001","title":"Placebo Plus Cognitive Training","description":"Placebo plus cognitive training 5 times weekly for 30 minutes a day\n\nCognitive training program: Online training 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":49}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Eric Lenze","organization":"Washington University School of Medicine","email":"lenzee@wustl.edu","phone":"314-362-1671"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2016-09-23","uploadDate":"2019-12-27T14:30","filename":"Prot_SAP_000.pdf","size":308377}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D000078784","term":"Vortioxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic 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