Longitudinal head-to-head comparison of
18F-florbetapir
Dominantly inherited Alzheimer’s disease
Gantenerumab
Pittsburgh compound B
Journal
European journal of nuclear medicine and molecular imaging
ISSN: 1619-7089
Titre abrégé: Eur J Nucl Med Mol Imaging
Pays: Germany
ID NLM: 101140988
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
received:
08
12
2022
accepted:
18
03
2023
medline:
5
7
2023
pubmed:
6
4
2023
entrez:
5
4
2023
Statut:
ppublish
Résumé
Pittsburgh Compound-B ( Sixty-six mutation-positive participants enrolled in the gantenerumab and placebo arms of the first Dominantly Inherited Alzheimer Network Trials Unit clinical trial (DIAN-TU-001) underwent both In the placebo arm, the absolute rate of longitudinal change measured by global cortical Gantenerumab treatment induces longitudinal changes in Aβ PET, and the absolute rates of these longitudinal changes differ significantly between Aβ radiotracers. These differences were not seen in the placebo arm, suggesting that Aβ-clearing treatments may pose unique challenges when attempting to compare longitudinal results across different Aβ radiotracers. Our results suggest converting Aβ PET SUVR measurements to Centiloids (both globally and regionally) can harmonize these differences without losing sensitivity to drug effects. Nonetheless, until consensus is achieved on how to harmonize drug effects across radiotracers, and since using multiple radiotracers in the same trial may increase type I error, multisite studies should consider potential variability due to different radiotracers when interpreting Aβ PET biomarker data and, if feasible, use a single radiotracer for the best results. ClinicalTrials.gov NCT01760005. Registered 31 December 2012. Retrospectively registered.
Identifiants
pubmed: 37017737
doi: 10.1007/s00259-023-06209-0
pii: 10.1007/s00259-023-06209-0
pmc: PMC10330155
mid: NIHMS1894746
doi:
Substances chimiques
florbetapir
6867Q6IKOD
Amyloid beta-Peptides
0
Aniline Compounds
0
Ethylene Glycols
0
Banques de données
ClinicalTrials.gov
['NCT01760005']
Types de publication
Clinical Trial, Phase III
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2669-2682Subventions
Organisme : NIH HHS
ID : U19AG032438
Pays : United States
Organisme : NIH HHS
ID : U01AG042791
Pays : United States
Organisme : NIH HHS
ID : P30NS098577
Pays : United States
Organisme : NINDS NIH HHS
ID : P30 NS098577
Pays : United States
Organisme : NIH HHS
ID : R01AG046179
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG053267
Pays : United States
Organisme : NIA NIH HHS
ID : UF1 AG032438
Pays : United States
Organisme : NIH HHS
ID : R01AG53267-S1
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG052550
Pays : United States
Organisme : NIA NIH HHS
ID : U01 AG042791
Pays : United States
Organisme : NIH HHS
ID : U01AG042791-S1
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG046179
Pays : United States
Organisme : NIA NIH HHS
ID : T32 AG058518
Pays : United States
Organisme : NIA NIH HHS
ID : K01 AG080123
Pays : United States
Organisme : NIA NIH HHS
ID : U19 AG032438
Pays : United States
Organisme : NIH HHS
ID : R01AG052550-01A1
Pays : United States
Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Salloway S, Farlow M, McDade E, Clifford DB, Wang G, Llibre-Guerra JJ, et al. Dominantly inherited alzheimer network–trials unit. A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer's disease. Nat Med. 2021;27(7):1187–96. https://doi.org/10.1038/s41591-021-01369-8 .
Liu E, Schmidt ME, Margolin R, et al. Amyloid-β 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015;85:692–700.
doi: 10.1212/WNL.0000000000001877
pubmed: 26208959
pmcid: 4553028
Landen JW, Andreasen N, Cronenberger CL, et al. Ponezumab in mild-to-moderate Alzheimer’s disease: randomized phase II PET-PIB study. Alzheimers Dement (N Y). 2017;3:393–401.
doi: 10.1016/j.trci.2017.05.003
pubmed: 29067345
Sevigny J, Chiao P, Bussière T, et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature. 2016;537:50–6.
doi: 10.1038/nature19323
pubmed: 27582220
Mintun MA, Lo AC, Duggan Evans C, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. 2021;384:1691–704.
doi: 10.1056/NEJMoa2100708
pubmed: 33720637
Klein G, Delmar P, Voyle N, et al. Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer’s disease: a PET substudy interim analysis. Alzheimer’s Res Ther. 2019;11:101.
doi: 10.1186/s13195-019-0559-z
Swanson CJ, Zhang Y, Dhadda S, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody. Alz Res Ther. 2021;13:80.
doi: 10.1186/s13195-021-00813-8
Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, et al. Trial of solanezumab for mild dementia due to Alzheimer’s disease. N Engl J Med. 2018;378(4):321–30. https://doi.org/10.1056/NEJMoa1705971 .
Wolk DA, Zhang Z, Boudhar S, Clark CM, Pontecorvo MJ, Arnold SE. Amyloid imaging in Alzheimer’s disease: comparison of Florbetapir and Pittsburgh Compound-B PET. J Neurol Neurosurg Psychiatry. 2012;83:923–6.
doi: 10.1136/jnnp-2012-302548
pubmed: 22791901
Ni R, Gillberg P-G, Bergfors A, Marutle A, Nordberg A. Amyloid tracers detect multiple binding sites in Alzheimer’s disease brain tissue. Brain. 2013;136:2217–27.
doi: 10.1093/brain/awt142
pubmed: 23757761
Su Y, Flores S, Wang G, et al. Comparison of Pittsburgh compound B and florbetapir in cross-sectional and longitudinal studies. Alzheimer’s Dement Diagn Assess Dis Monit. 2019;11:180.
Landau SM, Thomas BA, Thurfjell L, et al. Amyloid PET imaging in Alzheimer’s disease: a comparison of three radiotracers. Eur J Nucl Med Mol Imaging. 2014;41:1398–407.
doi: 10.1007/s00259-014-2753-3
pubmed: 24647577
pmcid: 4055504
Thomas BA, Erlandsson K, Modat M, et al. The importance of appropriate partial volume correction for PET quantification in Alzheimer’s disease. Eur J Nucl Med Mol Imaging. 2011;38:1104–19.
doi: 10.1007/s00259-011-1745-9
pubmed: 21336694
Klunk WE, Koeppe RA, Price JC, et al. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015;11:1–15 (e1-4).
doi: 10.1016/j.jalz.2014.07.003
pubmed: 25443857
Benzinger TLS, Blazey T, Jack CR, et al. Regional variability of imaging biomarkers in autosomal dominant Alzheimer’s disease. Proc Natl Acad Sci U S A. 2013;110:E4502-4509.
doi: 10.1073/pnas.1317918110
pubmed: 24194552
pmcid: 3839740
Morris JC, Aisen PS, Bateman RJ, et al. Developing an international network for Alzheimer research: the Dominantly Inherited Alzheimer Network. Clin Investig (Lond). 2012;2:975–84.
doi: 10.4155/cli.12.93
pubmed: 23139856
McKay NS, Gordon BA, Hornbeck RC, et al. Neuroimaging within the Dominantly Inherited Alzheimer’s Network (DIAN): PET and MRI. March 2022:2022.03.25.485799.
Su Y, D’Angelo GM, Vlassenko AG, et al. Quantitative Analysis of PiB-PET with FreeSurfer ROIs. PLoS ONE. 2013;8:e73377.
doi: 10.1371/journal.pone.0073377
pubmed: 24223109
pmcid: 3819320
Su Y, Blazey TM, Snyder AZ, et al. Partial volume correction in quantitative amyloid imaging. Neuroimage. 2015;107:55–64.
doi: 10.1016/j.neuroimage.2014.11.058
pubmed: 25485714
Fischl B. FreeSurfer. NeuroImage. 2012;62:774–81.
doi: 10.1016/j.neuroimage.2012.01.021
pubmed: 22248573
Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J Roy Stat Soc: Ser B (Methodol). 1995;57:289–300.
R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2021.
Tentolouris-Piperas V, Ryan NS, Thomas DL, Kinnunen KM. Brain imaging evidence of early involvement of subcortical regions in familial and sporadic Alzheimer’s disease. Brain Res. 2017;1655:23–32.
doi: 10.1016/j.brainres.2016.11.011
pubmed: 27847196
Klunk WE, Price JC, Mathis CA, et al. Amyloid deposition begins in the striatum of presenilin-1 mutation carriers from two unrelated pedigrees. J Neurosci. 2007;27:6174–84.
doi: 10.1523/JNEUROSCI.0730-07.2007
pubmed: 17553989
pmcid: 3265970
Chen CD, Joseph-Mathurin N, Sinha N, et al. Comparing amyloid-β plaque burden with antemortem PiB PET in autosomal dominant and late-onset Alzheimer disease. Acta Neuropathol. 2021;142:689–706.
doi: 10.1007/s00401-021-02342-y
pubmed: 34319442
pmcid: 8815340
Annus T, Wilson LR, Hong YT, et al. The pattern of amyloid accumulation in the brains of adults with Down syndrome. Alzheimers Dement. 2016;12:538–45.
doi: 10.1016/j.jalz.2015.07.490
pubmed: 26362596
pmcid: 4867786
Rosenstiel P von, Gheuens S, Chen T, et al. Aducanumab titration dosing regimen: 24-month analysis from PRIME, a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease (S2.003). Neurology. 2018;90.
Lowe SL, Willis BA, Hawdon A, et al. Donanemab (LY3002813) dose-escalation study in Alzheimer’s disease. Alzheimers Dement (N Y). 2021;7:e12112.
doi: 10.1002/trc2.12112
pubmed: 33614890
Retout S, Gieschke R, Serafin D, Weber C, Frey N, Hofmann C. Disease modeling and model-based meta-analyses to define a new direction for a phase III program of gantenerumab in Alzheimer’s disease. Clin Pharmacol Ther. 2022;111:857–66.
doi: 10.1002/cpt.2535
pubmed: 35100444
pmcid: 9313867
Sweeney MD, Sagare AP, Zlokovic BV. Blood–brain barrier breakdown in Alzheimer disease and other neurodegenerative disorders. Nat Rev Neurol. 2018;14:133–50.
doi: 10.1038/nrneurol.2017.188
pubmed: 29377008
pmcid: 5829048
Potter R, Patterson BW, Elbert DL, et al. Increased in vivo amyloid-β42 production, exchange, and irreversible loss in presenilin mutations carriers. Sci Transl Med. 2013;5:189ra77. https://doi.org/10.1126/scitranslmed.3005615 .
doi: 10.1126/scitranslmed.3005615
pubmed: 23761040
Shah J, Gao F, Li B, Ghisays V, Luo J, Chen Y, et al. Deep residual inception encoder-decoder network for amyloid PET harmonization. Alzheimers Dement. 2022;18(12):2448–57. https://doi.org/10.1002/alz.12564 .
doi: 10.1002/alz.12564
pubmed: 35142053
pmcid: 9360199
Su Y, Flores S, Hornbeck RC, et al. Utilizing the Centiloid scale in cross-sectional and longitudinal PiB PET studies. Neuroimage Clin. 2018;19:406–16.
doi: 10.1016/j.nicl.2018.04.022
pubmed: 30035025
pmcid: 6051499
Tolboom N, Yaqub M, Boellaard R, et al. Test-retest variability of quantitative [11C]PIB studies in Alzheimer’s disease. Eur J Nucl Med Mol Imaging. 2009;36:1629–38.
doi: 10.1007/s00259-009-1129-6
pubmed: 19384547
pmcid: 2758198
Joshi AD, Pontecorvo MJ, Clark CM, et al. Performance characteristics of amyloid PET with florbetapir F 18 in patients with Alzheimer’s disease and cognitively normal subjects. J Nucl Med. 2012;53:378–84.
doi: 10.2967/jnumed.111.090340
pubmed: 22331215
Johnson KA, Sperling RA, Gidicsin CM, et al. Florbetapir (F18-AV-45) PET to assess amyloid burden in Alzheimer’s disease dementia, mild cognitive impairment, and normal aging. Alzheimer’s Dement. 2013;9:S72–83.
doi: 10.1016/j.jalz.2012.10.007