Correction to: A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease (Alzheimer's Research and Therapy (2017) 9 (95) DOI: 10.1186/s13195-017-0318-y);A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease

Alzheimer's Research and Therapy

Volumn 9, Issue 1, 2017, Pages

  Ostrowitzki, Susanne ^a   Lasser, Robert A ^b   Dorflinger, Ernest ^c   Scheltens, Philip ^d   Barkhof, Frederik ^d,e,f   Nikolcheva, Tania ^f   Ashford, Elizabeth ^g   Retout, Sylvie ^f   Hofmann, Carsten ^f   Delmar, Paul ^f   Klein, Gregory ^f   Andjelkovic, Mirjana ^f   Dubois, Bruno ^h   Boada, Mercè ⁱ   Blennow, Kaj ⁱ   Santarelli, Luca ^f   Fontoura, Paulo ^f  

^a GENENTECH INC   (United States)

^b MedPharma Partners   (United States)

^c Roche Translational Clinical Research Center Inc   (United States)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY COLLEGE LONDON   (United Kingdom)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

^g ROCHE PRODUCTS LTD   (United Kingdom)

^h PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

ⁱ Institut Catala de Neurociencies Aplicades   (Spain)

Author keywords

Alzheimer's disease; Gantenerumab; SCarlet RoAD

Indexed keywords

APOLIPOPROTEIN E4; GANTENERUMAB; PLACEBO; RO 4909832; AMYLOID BETA PROTEIN; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

AGED; ALZHEIMER DISEASE; APOE GENE; ARTICLE; CEREBROSPINAL FLUID ANALYSIS; CLINICAL DEMENTIA RATING SUM OF BOXES SCORE; CONTROLLED STUDY; DEMENTIA ASSESSMENT; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EAR DISEASE; GASTROINTESTINAL DISEASE; GENE; GENOTYPE; HEART DISEASE; HUMAN; INFECTION; INJECTION SITE REACTION; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MENTAL DISEASE; METABOLIC DISORDER; MUSCULOSKELETAL DISEASE; NEOPLASM; NEUROLOGIC DISEASE; PHASE 3 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PRODROMAL SYMPTOM; REPRODUCTIVE TOXICITY; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SKIN DISEASE; UROGENITAL TRACT DISEASE; VASCULAR DISEASE; CEREBROSPINAL FLUID; CLINICAL TRIAL; DIAGNOSTIC IMAGING; DOSE RESPONSE; GENETICS; LONGITUDINAL STUDY; MIDDLE AGED; MULTICENTER STUDY; NEUROPSYCHOLOGICAL TEST; NUCLEAR MAGNETIC RESONANCE IMAGING; PSYCHOLOGICAL RATING SCALE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

AGED; ALZHEIMER DISEASE; AMYLOID BETA-PEPTIDES; ANTIBODIES, MONOCLONAL; APOLIPOPROTEIN E4; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HUMANS; IMMUNOLOGIC FACTORS; LONGITUDINAL STUDIES; MAGNETIC RESONANCE IMAGING; MIDDLE AGED; NEUROPSYCHOLOGICAL TESTS; POSITRON-EMISSION TOMOGRAPHY; PRODROMAL SYMPTOMS; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME;

EID: 85037638075     PISSN: None     EISSN: 17589193     Source Type: Journal    
DOI: 10.1186/s13195-018-0409-4     Document Type: Erratum

References (34)

1. Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, et al. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012;367(9):795-804.
2. Haass C, Selkoe DJ. Soluble protein oligomers in neurodegeneration: lessons from the Alzheimer's amyloid beta-peptide. Nat Rev Mol Cell Biol. 2007;8(2):101-12.
3. Blennow K, de Leon MJ, Zetterberg H. Alzheimer's disease. Lancet. 2006;368(9533):387-403.
4. Dubois B, Feldman HH, Jacova C, DeKosky ST, Barberger-Gateau P, Cummings J, et al. Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007;6(8):734-46.
5. Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, et al. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):280-92.
6. Olsson B, Lautner R, Andreasson U, Ohrfelt A, Portelius E, Bjerke M, et al. CSF and blood biomarkers for the diagnosis of Alzheimer's disease: A systematic review and meta-Analysis. Lancet Neurol. 2016;15(7):673-84.
7. Bard F, Cannon C, Barbour R, Burke RL, Games D, Grajeda H, et al. Peripherally administered antibodies against amyloid beta-peptide enter the central nervous system and reduce pathology in a mouse model of Alzheimer disease. Nat Med. 2000;6(8):916-9.
8. Ostrowitzki S, Deptula D, Thurfjell L, Barkhof F, Bohrmann B, Brooks DJ, et al. Mechanism of amyloid removal in patients with Alzheimer disease treated with gantenerumab. Arch Neurol. 2012;69(2):198-207.
9. Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol. 1980;7(5):486-8.
10. Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993;43(11):2412-4.
11. Fleisher AS, Chen K, Liu X, Roontiva A, Thiyyagura P, Ayutyanont N, et al. Using positron emission tomography and florbetapir F18 to image cortical amyloid in patients with mild cognitive impairment or dementia due to Alzheimer disease. Arch Neurol. 2011;68(11):1404-11.
12. Rowe CC, Ackerman U, Browne W, Mulligan R, Pike KL, O'Keefe G, et al. Imaging of amyloid beta in Alzheimer's disease with 18 F-BAY94-9172, a novel PET tracer: proof of mechanism. Lancet Neurol. 2008;7(2):129-35.
13. Freeborough PA, Fox NC. The boundary shift integral: An accurate and robust measure of cerebral volume changes from registered repeat MRI. IEEE Trans Med Imaging. 1997;16(5):623-9.
14. Leung KK, Clarkson MJ, Bartlett JW, Clegg S, Jack Jr CR, Weiner MW, et al. Robust atrophy rate measurement in Alzheimer's disease using multi-site serial MRI: Tissue-specific intensity normalization and parameter selection. Neuroimage. 2010;50(2):516-23.
15. Bittner T, Zetterberg H, Teunissen CE, Ostlund Jr RE, Militello M, Andreasson U, et al. Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of beta-Amyloid (1-42) in human cerebrospinal fluid. Alzheimers Dement. 2016;12(5):517-26.
16. Davidsson P, Blennow K. Neurochemical dissection of synaptic pathology in Alzheimer's disease. Int Psychogeriatr. 1998;10(1):11-23.
17. Zetterberg H, Blennow K. Neurogranin levels in cerebrospinal fluid: A new addition to the Alzheimer disease diagnostic toolbox. JAMA Neurol. 2015;72(11):1237-8.
18. Kvartsberg H, Duits FH, Ingelsson M, Andreasen N, Ohrfelt A, Andersson K, et al. Cerebrospinal fluid levels of the synaptic protein neurogranin correlates with cognitive decline in prodromal Alzheimer's disease. Alzheimers Dement. 2015;11(10):1180-90.
19. Barkhof F, Daams M, Scheltens P, Brashear HR, Arrighi HM, Bechten A, et al. An MRI rating scale for amyloid-related imaging abnormalities with edema or effusion. AJNR Am J Neuroradiol. 2013;34(8):1550-5.
20. Delor I, Charoin JE, Gieschke R, Retout S, Jacqmin P. Modeling Alzheimer's disease progression using disease onset time and disease trajectory concepts applied to CDR-SOB scores from ADNI. CPT Pharmacometrics Syst Pharmacol. 2013;2, e78.
21. Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, et al. Two phase 3 trials of bapineuzumab in mild-To-moderate Alzheimer's disease. N Engl J Med. 2014;370(4):322-33.
22. Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, et al. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016;8(1):18.
23. Blennow K, Hampel H, Weiner M, Zetterberg H. Cerebrospinal fluid and plasma biomarkers in Alzheimer disease. Nat Rev Neurol. 2010;6(3):131-44.
24. Kester MI, Teunissen CE, Crimmins DL, Herries EM, Ladenson JH, Scheltens P, et al. Neurogranin as a cerebrospinal fluid biomarker for synaptic loss in symptomatic Alzheimer disease. JAMA Neurol. 2015;72(11):1275-80.
25. Sevigny J, Chiao P, Bussiere T, Weinreb PH, Williams L, Maier M, et al. The antibody aducanumab reduces Aβ plaques in Alzheimer's disease. Nature. 2016;537(7618):50-6.
26. Viglietta V, O'Gorman J, Williams L, Tian Y, Sandrock A, Doody R, Salloway S, Barkhof F, et al. Randomized, double-blind, placebo-controlled studies to evaluate treatment with aducanumab (BIIB037) in patients with early Alzheimer's disease: phase 3 study design [abstract]. Neurology. 2016;86(16 Suppl):S1.003.
27. Doody RS, Farlow M, Aisen PS, Alzheimer's Disease Cooperative Study Data Analysis and Publication Committee. Phase 3 trials of solanezumab and bapineuzumab for Alzheimer's disease. N Engl J Med. 2014;370(15):1460.
28. European Medicines Agency (EMA). Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer's disease and other dementias. London: EMA; 23 Oct 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/10/WC500176827.pdf. Accessed 7 July 2017.
29. Food and Drug Administration (FDA). Guidance for industry. Alzheimer's disease: developing drugs for the treatment of early stage disease Silver Spring, MD: Center for Drug Evaluation and Research, FDA; Feb 2013. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm338287.pdf. Accessed 7 July 2017.
30. Cedarbaum JM, Jaros M, Hernandez C, Coley N, Andrieu S, Grundman M, et al. Rationale for use of the Clinical Dementia Rating Sum of Boxes as a primary outcome measure for Alzheimer's disease clinical trials. Alzheimers Dement. 2013;9(1 Suppl):S45-55.
31. Coley N, Andrieu S, Jaros M, Weiner M, Cedarbaum J, Vellas B. Suitability of the Clinical Dementia Rating-Sum of Boxes as a single primary endpoint for Alzheimer's disease trials. Alzheimers Dement. 2011;7(6):602-10.e2.
32. Edgar C, Rylands A, Volz D, Mertes M, Gruendl E, Fontoura P, Santarelli L, Lasser R. Comparative traditional psychometrics of cognitive and functional endpoints in a prodromal Alzheimer's disease population. Presented at Clinical Trials on Alzheimer's Disease conference, Barcelona, Spain, November 2015
33. Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, et al. Targeting prodromal Alzheimer disease with avagacestat: A randomized clinical trial. JAMA Neurol. 2015;72(11):1324-33.
34. Williams MM, Storandt M, Roe CM, Morris JC. Progression of Alzheimer disease as measured by Clinical Dementia Rating Sum of Boxes scores. Alzheimers Dement. 2013;9(1 Suppl):S39-44.