2015
A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer’s disease
Nygaard HB, Wagner AF, Bowen GS, Good SP, MacAvoy MG, Strittmatter KA, Kaufman AC, Rosenberg BJ, Sekine-Konno T, Varma P, Chen K, Koleske AJ, Reiman EM, Strittmatter SM, van Dyck CH. A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer’s disease. Alzheimer's Research & Therapy 2015, 7: 35. PMID: 25874001, PMCID: PMC4396171, DOI: 10.1186/s13195-015-0119-0.Peer-Reviewed Original ResearchRegional cerebral glucose metabolismCerebral glucose metabolismTreatment of patientsClinical efficacy measuresModerate Alzheimer's diseaseAlzheimer's diseaseEfficacy measuresGlucose metabolismCentral nervous system availabilityMultiple ascending dose studyFluorodeoxyglucose positron emission tomographyPhase IIa clinical trialMini-Mental State Examination scoreCentral nervous system penetrationPromising new therapeutic targetCSF drug levelsMultiple ascending doseOligomeric amyloid betaPhase Ib trialPlacebo-controlled trialAscending dose studyCongestive heart failureCerebrospinal fluid penetrationDisease-modifying therapiesIIa clinical trial
2012
Safety and biomarker effects of solanezumab in patients with Alzheimer's disease
Farlow M, Arnold SE, van Dyck C, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimer's & Dementia 2012, 8: 261-271. PMID: 22672770, DOI: 10.1016/j.jalz.2011.09.224.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedCognition DisordersDose-Response Relationship, DrugDouble-Blind MethodElectroencephalographyEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuropsychological TestsPeptide FragmentsPsychiatric Status Rating ScalesPyridinesTomography, Emission-Computed, Single-PhotonTreatment OutcomeConceptsAlzheimer's Disease Assessment Scale-cognitive portionAntibody administrationDose-dependent mannerAlzheimer's diseaseAntibody treatmentAnti-β-amyloid antibodiesPlacebo-controlled clinical trialMagnetic resonance imaging (MRI) scansCerebrospinal fluid examinationClinical laboratory valuesActive treatment periodCSF cell countResonance imaging scansModerate Alzheimer's diseaseDose-dependent increaseMagnetic resonance imagingWeekly infusionsAdverse eventsFluid examinationImaging scansClinical trialsLaboratory valuesTreatment periodAmyloid plaquesCell count
2011
O4‐06‐07: Imaging and cerebrospinal fluid biomarker results of a phase II dose‐ranging study of ELND005 (Scyllo‐inositol) in mild‐to‐moderate Alzheimer's disease
Porsteinsson A, Sperling R, Salloway S, Keren R, van Dyck C, Tariot P, Arnold D, Crans G, Hernandez R, Liang E, Bairu M, Cedarbaum J, Pastrak A, Abushakra S. O4‐06‐07: Imaging and cerebrospinal fluid biomarker results of a phase II dose‐ranging study of ELND005 (Scyllo‐inositol) in mild‐to‐moderate Alzheimer's disease. Alzheimer's & Dementia 2011, 7: s695-s695. DOI: 10.1016/j.jalz.2011.05.2010.Peer-Reviewed Original ResearchPhase II dose-ranging studyDose-ranging studyModerate Alzheimer's diseaseAlzheimer's diseaseBiomarker resultsDiseaseP2‐499: Safety and efficacy results of a phase II randomized, placebo‐controlled, dose‐ranging study of elnd005 (scyllo‐inositol) in mild‐to‐moderate Alzheimer's disease
Salloway S, Porsteinsson A, Sperling R, Keren R, van Dyck C, Tariot P, Gilman S, Crans G, Hernandez R, Quinn G, Bairu M, Cedarbaum J, Pastrak A, Abushakra S. P2‐499: Safety and efficacy results of a phase II randomized, placebo‐controlled, dose‐ranging study of elnd005 (scyllo‐inositol) in mild‐to‐moderate Alzheimer's disease. Alzheimer's & Dementia 2011, 7: s472-s472. DOI: 10.1016/j.jalz.2011.05.1371.Peer-Reviewed Original ResearchDose-ranging studyModerate Alzheimer's diseaseEfficacy resultsAlzheimer's diseasePhase IIDiseaseMildO4‐06‐08: Safety and tolerability of BMS‐708163 in a phase II study in mild‐to‐moderate Alzheimer's disease
Salloway S, Coric V, Brody M, Andreasen N, van Dyck C, Soininen H, Thein S, Shiovitz T, Kumar S, Pilcher G, Colby S, Rollin L, Feldman H, Berman R. O4‐06‐08: Safety and tolerability of BMS‐708163 in a phase II study in mild‐to‐moderate Alzheimer's disease. Alzheimer's & Dementia 2011, 7: s695-s696. DOI: 10.1016/j.jalz.2011.05.2011.Peer-Reviewed Original Research
2000
Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Study L. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. Obstetrical & Gynecological Survey 2000, 55: 439-440. DOI: 10.1097/00006254-200007000-00021.Peer-Reviewed Original ResearchMini-Mental State ExaminationCognitive functionAlzheimer's diseaseMultiple Affect Adjective ChecklistMeasures of moodMMSE scoresSingle-blind placebo washout phaseVerbal learningLanguage measuresClinical Dementia Rating ScaleCategory fluencyPlacebo washout phaseDouble-blind trialLow-dose estrogenConjugated equine estrogensEstrogen replacement therapyDementia Rating ScaleTreatment of mildClinical Global ImpressionPrimary outcome measureHamilton Depression ScaleAdjective ChecklistModerate Alzheimer's diseaseOnset of diseaseGlobal functioningEstrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal L, Study F. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. JAMA 2000, 283: 1007-1015. PMID: 10697060, DOI: 10.1001/jama.283.8.1007.Peer-Reviewed Original ResearchConceptsEstrogen replacement therapyModerate Alzheimer's diseaseSecondary outcome measuresReplacement therapyAlzheimer's diseaseOutcome measuresClinical trialsPlacebo-controlled clinical trialMini-Mental State Examination scoreAlzheimer's Disease Cooperative StudyPrevention of ADClinical Dementia Rating ScaleClinical Global ImpressionPrimary outcome measureTreatment of mildSmall clinical trialsRole of estrogenState Examination scoreDementia Rating ScaleCGIC scoresEstrogen groupPlacebo groupControlled TrialsFunctional outcomeGlobal Impression