2025
Safety and efficacy of repeat ivermectin mass drug administrations for malaria control (RIMDAMAL II): a phase 3, double-blind, placebo-controlled, cluster-randomised, parallel-group trial
Somé A, Somé A, Sougué E, Ouédraogo C, Da O, Dah S, Nikièma F, Magalhaes T, Gray L, Finical W, Pugh G, Lado P, Randall J, Burton T, Ring M, Leon A, Colt M, Li F, Wang K, Wade M, Lier A, Richards K, Sproch H, Zhang E, Ellman J, Achebe I, Jackson C, Xiao M, Wu E, Bousema T, Slater H, Foy B, Parikh S, Dabiré R. Safety and efficacy of repeat ivermectin mass drug administrations for malaria control (RIMDAMAL II): a phase 3, double-blind, placebo-controlled, cluster-randomised, parallel-group trial. The Lancet Infectious Diseases 2025, 25: 737-750. PMID: 39919778, DOI: 10.1016/s1473-3099(24)00751-5.Peer-Reviewed Original ResearchSeasonal malaria chemopreventionIvermectin mass drug administrationEntomological inoculation rateMalaria incidenceParallel-group trialMass drug administrationDouble-blindPlacebo-ControlledControl groupAdverse eventsPrimary outcomeWeekly active case detectionDrug AdministrationLow malaria incidenceIntervention groupReducing malaria incidenceMalaria-endemic regionsMalaria incidence ratesRisk of adverse eventsInoculation rateNational Institute of AllergyPan African Clinical Trials RegistryComplementary vector control toolsCluster-randomisedInstitute of Allergy
2024
A pilot study to evaluate the effect of CT1812 treatment on synaptic density and other biomarkers in Alzheimer’s disease
van Dyck C, Mecca A, O’Dell R, Bartlett H, Diepenbrock N, Huang Y, Hamby M, Grundman M, Catalano S, Caggiano A, Carson R. A pilot study to evaluate the effect of CT1812 treatment on synaptic density and other biomarkers in Alzheimer’s disease. Alzheimer's Research & Therapy 2024, 16: 20. PMID: 38273408, PMCID: PMC10809445, DOI: 10.1186/s13195-024-01382-2.Peer-Reviewed Original ResearchConceptsMild to moderate dementiaPositron emission tomographyAlzheimer's diseaseVolumetric MRIModerate dementiaClinical rating scalesSynaptic vesicle glycoprotein 2ACerebrospinal fluidMouse model of ADPharmacodynamic effectsPlacebo-controlled phase 1 clinical trialBiomarkers of AD pathologyClinical trialsCognitive measuresNominally significant differencesPhase 1 clinical trialModel of ADHippocampal cortexPhase 1/2 studyRating ScaleParallel-group trialSynaptic densityTrial registrationThe clinical trialPlacebo-ControlledSigma-2 receptor ligands
2023
Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program
Wunderlich G, Blahova Z, Hake S, Ikezawa S, Marder S, Falkai P, Krystal J. Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program. CNS Spectrums 2023, 28: 229-229. DOI: 10.1017/s1092852923001530.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsPlacebo-controlled parallel-group trialKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scoreMulti-center studyPhase III programRole of glutamateLong-term safetyScale total scoreDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment toolII trialTolerability dataRepeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria
Foy B, Some A, Magalhaes T, Gray L, Rao S, Sougue E, Jackson C, Kittelson J, Slater H, Bousema T, Da O, Coulidiaty A, Colt M, Wade M, Richards K, Some A, Dabire R, Parikh S. Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria. JMIR Research Protocols 2023, 12: e41197. PMID: 36939832, PMCID: PMC10132043, DOI: 10.2196/41197.Peer-Reviewed Original ResearchIvermectin mass drug administrationMass drug administrationINTERNATIONAL REGISTERED REPORT IDENTIFIERMalaria incidenceDrug AdministrationMalaria transmissionIntense seasonal malaria transmissionMalaria controlSecondary safety outcomesParallel-group trialSeasonal malaria transmissionAdverse event monitoringActive case surveillancePrimary outcomeControl IINonpregnant individualsPostintervention changesTrial interventionCare interventionsSafety outcomesCluster RandomizedSubset of individualsCase surveillanceConsecutive daysEntomological assessmentsEfficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme
Falkai P, Reuteman-Fowler C, Blahova Z, Ikezawa S, Marder S, Krystal J. Efficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme. European Psychiatry 2023, 66: s637-s637. PMCID: PMC10661489, DOI: 10.1192/j.eurpsy.2023.1325.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsJazz PharmaceuticalsPlacebo-controlled parallel-group trialBoehringer IngelheimKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scorePhase III programRole of glutamateLong-term safetyScale total scoreGrant/research supportDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment tool
2022
Efficacy and Safety of Cholinesterase Inhibitors in Alzheimer’s Disease: A Meta-analysis
Lane C, Conroy M. Efficacy and Safety of Cholinesterase Inhibitors in Alzheimer’s Disease: A Meta-analysis. 2022, 303-306. DOI: 10.1007/978-3-030-94960-0_53.Peer-Reviewed Original Research
2020
Overview of dominantly inherited AD and top‐line DIAN‐TU results of solanezumab and gantenerumab
Bateman R, Aschenbrenner A, Benzinger T, Clifford D, Coalier K, Cruchaga C, Fagan A, Farlow M, Goate A, Gordon B, Hassenstab J, Jack C, Koeppe R, McDade E, Mills S, Morris J, Salloway S, Santacruz A, Snyder P, Wang G, Xiong C, Snider B, Mummery C, Surti G, Hannequin D, Wallon D, Berman S, Lah J, Jiménez‐Velazquez I, Roberson E, Dyck C, Honig L, Sanchez‐Valle R, Brooks W, Gauthier S, Masters C, Galasko D, Brosch J, Hsiung G, Jayadev S, Formaglio M, Masellis M, Clarnette R, Pariente J, Dubois B, Pasquier F, Andersen S, Holdridge K, Mintun M, Sims J, Yaari R, Baudler M, Delmar P, Doody R, Fontoura P, Kerchner G, Team D. Overview of dominantly inherited AD and top‐line DIAN‐TU results of solanezumab and gantenerumab. Alzheimer's & Dementia 2020, 16 DOI: 10.1002/alz.041129.Peer-Reviewed Original ResearchDisease prevention trialsPrevention trialsAlzheimer's disease prevention trialsDifferent antigenic targetsSignificant neuronal lossKey secondary outcomesParallel-group trialAD prevention trialsAdaptive platform trialFuture clinical trialsBeta monoclonal antibodyTiming of treatmentSymptomatic ADLast patientSecondary outcomesSymptom onsetNeuronal lossTop-line resultsTreatment trialsTau-PETAntigenic targetsBrain damageClinical trialsPlatform trialsAD hypothesesA Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. New England Journal Of Medicine 2020, 383: 836-845. PMID: 32846062, PMCID: PMC7920146, DOI: 10.1056/nejmoa2004736.Peer-Reviewed Original ResearchConceptsType 1 diabetesSensor-augmented insulin pumpClosed-loop groupGlucose levelsMedian percentageTarget rangeInsulin pumpInsulin deliveryParallel-group trialYears of ageContinuous glucose monitoringDiabetic ketoacidosisPrimary outcomeSevere hypoglycemiaHemoglobin levelsRandomized trialsGlycemic outcomesPercentage of timeChildren 6Control groupType 1DiabetesMean percentageGlucose monitoringTrialsNintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial
Wells A, Flaherty K, Brown K, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts W, Stowasser S, Quaresma M, Goeldner R, Schlenker-Herceg R, Kolb M, investigators I, Abe S, Aburto M, Acosta O, Andrews C, Antin-Ozerkis D, Arce G, Arias M, Avdeev S, Barczyk A, Bascom R, Bazdyrev E, Beirne P, Belloli E, Bergna M, Bergot E, Bhatt N, Blaas S, Bondue B, Bonella F, Britt E, Buch K, Burk J, Cai H, Cantin A, Villegas D, Cazaux A, Cerri S, Chaaban S, Chaudhuri N, Cottin V, Crestani B, Criner G, Dahlqvist C, Danoff S, D'Amico J, Dilling D, Elias P, Ettinger N, Falk J, Pérez E, Gamez-Dubuis A, Giessel G, Gifford A, Glassberg M, Glazer C, Golden J, Carrera L, Guiot J, Hallowell R, Hayashi H, Hetzel J, Hirani N, Homik L, Hope-Gill B, Hotchkin D, Ichikado K, Ilkovich M, Inoue Y, Izumi S, Jassem E, Jones L, Jouneau S, Kaner R, Kang J, Kawamura T, Kessler R, Kim Y, Kishi K, Kitamura H, Kolb M, Kondoh Y, Kono C, Koschel D, Kreuter M, Kulkarni T, Kus J, Lebargy F, Jiménez A, Luo Q, Mageto Y, Maher T, Makino S, Marchand-Adam S, Marquette C, Martinez R, Martínez M, Rozas R, Miyazaki Y, Moiseev S, Molina-Molina M, Morrison L, Morrow L, Moua T, Nambiar A, Nishioka Y, Nunes H, Okamoto M, Oldham J, Otaola M, Padilla M, Park J, Patel N, Pesci A, Piotrowski W, Pitts L, Poonyagariyagorn H, Prasse A, Quadrelli S, Randerath W, Refini R, Reynaud-Gaubert M, Riviere F, Portal J, Rosas I, Rossman M, Safdar Z, Saito T, Sakamoto N, Fénero M, Sauleda J, Schmidt S, Scholand M, Schwartz M, Shapera S, Shlobin O, Sigal B, Orellana A, Skowasch D, Song J, Stieglitz S, Stone H, Strek M, Suda T, Sugiura H, Takahashi H, Takaya H, Takeuchi T, Thavarajah K, Tolle L, Tomassetti S, Tomii K, Valenzuela C, Vancheri C, Varone F, Veeraraghavan S, Villar A, Weigt S, Wemeau L, Wuyts W, Xu Z, Yakusevich V, Yamada Y, Yamauchi H, Ziora D. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. The Lancet Respiratory Medicine 2020, 8: 453-460. PMID: 32145830, DOI: 10.1016/s2213-2600(20)30036-9.Peer-Reviewed Original ResearchConceptsInterstitial lung diseaseIdiopathic pulmonary fibrosisIdiopathic non-specific interstitial pneumoniaAutoimmune interstitial lung diseaseUnclassifiable idiopathic interstitial pneumoniaNon-specific interstitial pneumoniaDose of nintedanibParallel-group trialIdiopathic interstitial pneumoniaEffect of nintedanibINBUILD trialInterstitial pneumoniaILD diagnosisHigh-resolution CTILD progressionFVC declineHypersensitivity pneumonitisProgressive fibrosing interstitial lung diseasesOverall populationInterstitial lung disease diagnosisChest imaging featuresProtocol-defined criteriaSafety of nintedanibChronic hypersensitivity pneumonitisDisease subgroup analyses
2019
Feasibility and effects of galantamine on cognition in humans with cannabis use disorder
Sugarman DE, De Aquino JP, Poling J, Sofuoglu M. Feasibility and effects of galantamine on cognition in humans with cannabis use disorder. Pharmacology Biochemistry And Behavior 2019, 181: 86-92. PMID: 31082417, PMCID: PMC6545124, DOI: 10.1016/j.pbb.2019.05.004.Peer-Reviewed Original ResearchConceptsCannabis use disorderEffects of galantamineMeasures of attentionSelf-report measuresAdministration of galantamineOutpatient treatment periodPlacebo-controlled trialParallel-group trialTime pointsAcute cannabis intoxicationSignificant adverse effectsLong-term useSignificant main effectResponse inhibitionCognitive effectsCognitive performanceCognitive outcomesBaseline variablesCognitive AssessmentCognitive deficitsCannabis withdrawalTreatment periodProcognitive effectsGalantamine administrationBaseline sessions
2016
Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial
Tashkin DP, Roth MD, Clements PJ, Furst DE, Khanna D, Kleerup EC, Goldin J, Arriola E, Volkmann ER, Kafaja S, Silver R, Steen V, Strange C, Wise R, Wigley F, Mayes M, Riley DJ, Hussain S, Assassi S, Hsu VM, Patel B, Phillips K, Martinez F, Golden J, Connolly MK, Varga J, Dematte J, Hinchcliff ME, Fischer A, Swigris J, Meehan R, Theodore A, Simms R, Volkov S, Schraufnagel DE, Scholand MB, Frech T, Molitor JA, Highland K, Read CA, Fritzler MJ, Kim GHJ, Tseng CH, Elashoff RM, Investigators S. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. The Lancet Respiratory Medicine 2016, 4: 708-719. PMID: 27469583, PMCID: PMC5014629, DOI: 10.1016/s2213-2600(16)30152-7.Peer-Reviewed Original ResearchConceptsInterstitial lung diseaseMycophenolate mofetilParallel-group trialLung diseaseOral cyclophosphamidePrimary endpointCyclophosphamide groupGroup trialsPrimary analysisProgressive interstitial lung diseaseMycophenolate mofetil groupUS medical centersTreatment of sclerodermaProgression of sclerodermaPotential clinical effectivenessModified intentionProgressive sclerodermaStudy drugGood tolerabilityHRCT studiesLung functionPulmonary functionTreat analysisTreatment failureVital capacity
2015
Meta-Analysis: Risk of Tics Associated With Psychostimulant Use in Randomized, Placebo-Controlled Trials
Cohen SC, Mulqueen JM, Ferracioli-Oda E, Stuckelman ZD, Coughlin CG, Leckman JF, Bloch MH. Meta-Analysis: Risk of Tics Associated With Psychostimulant Use in Randomized, Placebo-Controlled Trials. Journal Of The American Academy Of Child & Adolescent Psychiatry 2015, 54: 728-736. PMID: 26299294, DOI: 10.1016/j.jaac.2015.06.011.Peer-Reviewed Original ResearchConceptsWorsening of ticsRisk of ticsAttention-deficit/hyperactivity disorderPlacebo-controlled trialNew onsetDuration of treatmentPsychostimulant usePsychostimulant medicationNew-onset ticsType of psychostimulantsParallel-group trialStratified subgroup analysisSide effect dataTreatment of childrenAge of participantsPlacebo groupAdverse eventsCrossover studyPsychostimulant treatmentTic symptomsRisk ratioSubgroup analysisFamily historyGroup trialsPubMed search
2007
Lamotrigine as Add-On Therapy in Schizophrenia
Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as Add-On Therapy in Schizophrenia. Journal Of Clinical Psychopharmacology 2007, 27: 582-589. PMID: 18004124, DOI: 10.1097/jcp.0b013e31815abf34.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnticonvulsantsAntipsychotic AgentsClozapineDiagnostic and Statistical Manual of Mental DisordersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug ResistanceDrug Therapy, CombinationFemaleHumansLamotrigineMaleMiddle AgedPatient CompliancePatient DropoutsPsychiatric Status Rating ScalesSchizophreniaSeverity of Illness IndexSuicide, AttemptedTreatment OutcomeTriazinesConceptsNegative Syndrome Scale total scoreScale total scoreAntipsychotic medicationTotal scoreTreatment groupsSchizophrenia patientsPlacebo-controlled trialPrimary end pointParallel-group trialUse of lamotrigineClinical Global ImpressionAtypical antipsychotic medicationsResidual psychotic symptomsSymptom total scoreNegative Symptoms total scoreLamotrigine augmentationLamotrigine trialsRefractory psychosisAtypical antipsychoticsCognitive composite scoreWeek 12Global ImpressionTreat samplePsychotic symptomsLamotrigine
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