% IMPORTANT: The following is UTF-8 encoded. This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.
@ARTICLE{Wagemann:269526,
author = {Wagemann, Olivia and Liu, Haiyan and Wang, Guoqiao and Shi,
Xinyu and Bittner, Tobias and Scelsi, Marzia A. and Farlow,
Martin R. and Clifford, David B. and Supnet-Bell, Charlene
and Santacruz, Anna M. and Aschenbrenner, Andrew J. and
Hassenstab, Jason J. and Benzinger, Tammie L. S. and Gordon,
Brian A. and Coalier, Kelley A. and Cruchaga, Carlos and
Ibanez, Laura and Perrin, Richard J. and Xiong, Chengjie and
Li, Yan and Morris, John C. and Lah, James J. and Berman,
Sarah B. and Roberson, Erik D. and van Dyck, Christopher H.
and Galasko, Douglas and Gauthier, Serge and Hsiung,
Ging-Yuek R. and Brooks, William S. and Pariente, Jérémie
and Mummery, Catherine J. and Day, Gregory S. and Ringman,
John M. and Mendez, Patricio Chrem and St. George-Hyslop,
Peter and Fox, Nick C. and Suzuki, Kazushi and Okhravi,
Hamid R. and Chhatwal, Jasmeer and Levin, Johannes and
Jucker, Mathias and Sims, John R. and Holdridge, Karen C.
and Proctor, Nicholas K. and Yaari, Roy and Andersen, Scott
W. and Mancini, Michele and Llibre-Guerra, Jorge and
Bateman, Randall J. and McDade, Eric and Daniels, Alisha J.
and Courtney, Laura and Xu, Xiong and Lu, Ruijin and
Gremminger, Emily and Franklin, Erin and Ibanez, Laura and
Jerome, Gina and Herries, Elizabeth and Stauber, Jennifer
and Baker, Bryce and Minton, Matthew and Goate, Alison M.
and Renton, Alan E. and Picarello, Danielle M. and Hornbeck,
Russ and Chen, Allison and Chen, Charles and Flores, Shaney
and Joseph-Mathurin, Nelly and Jarman, Steve and Jackson,
Kelley and Keefe, Sarah and Koudelis, Deborah and
Massoumzadeh, Parinaz and McCullough, Austin and McKay,
Nicole and Nicklaus, Joyce and Pulizos, Christine and Wang,
Qing and Sabaredzovic, Edita and Smith, Hunter and Scott,
Jalen and Simmons, Ashlee and Rizzo, Jacqueline and Smith,
Jennifer and Stout, Sarah and Karch, Celeste M. and Marsh,
Jacob and Holtzman, David M. and Barthelemy, Nicolas and Xu,
Jinbin and Noble, James M. and Ikonomovic, Snezana and
Nadkarni, Neelesh K. and Graff-Radford, Neill R. and
Ikeuchi, Takeshi and Kasuga, Kensaku and Niimi, Yoshiki and
Huey, Edward D. and Salloway, Stephen and Schofield, Peter
R. and Bechara, Jacob A. and Martins, Ralph and Cash, David
M. and Ryan, Natalie S. and Laske, Christoph and Hofmann,
Anna and Kuder-Buletta, Elke and Gräber-Sultan, Susanne and
Obermueller, Ulrike and Rödenbeck, Yvonne Esther and
Vӧglein, Jonathan and Lee, Jae-Hong and Roh, Jee Hoon and
Sanchez-Valle, Raquel and Rosa-Neto, Pedro and Allegri,
Ricardo F. and Surace, Ezequiel and Vazquez, Silvia and
Lopera, Francisco and Leon, Yudy Milena and Ramirez, Laura
and Aguillon, David and Levey, Allan I. and Johnson, Erik C.
B and Seyfried, Nicholas T. and Fagan, Anne M. and Mori,
Hiroshi and Masters, Colin},
title = {{D}ownstream {B}iomarker {E}ffects of {G}antenerumab or
{S}olanezumab in {D}ominantly {I}nherited {A}lzheimer
{D}isease},
journal = {JAMA neurology},
volume = {81},
number = {6},
issn = {2168-6149},
address = {Chicago, Ill.},
publisher = {American Medical Association},
reportid = {DZNE-2024-00567},
pages = {582 - 593},
year = {2024},
abstract = {Importance Effects of antiamyloid agents, targeting either
fibrillar or soluble monomeric amyloid peptides, on
downstream biomarkers in cerebrospinal fluid (CSF) and
plasma are largely unknown in dominantly inherited Alzheimer
disease (DIAD).Objective To investigate longitudinal
biomarker changes of synaptic dysfunction,
neuroinflammation, and neurodegeneration in individuals with
DIAD who are receiving antiamyloid treatment.Design,
Setting, and Participants From 2012 to 2019, the Dominantly
Inherited Alzheimer Network Trial Unit (DIAN-TU-001) study,
a double-blind, placebo-controlled, randomized clinical
trial, investigated gantenerumab and solanezumab in DIAD.
Carriers of gene variants were assigned 3:1 to either drug
or placebo. The present analysis was conducted from April to
June 2023. DIAN-TU-001 spans 25 study sites in 7 countries.
Biofluids and neuroimaging from carriers of DIAD gene
variants in the gantenerumab, solanezumab, and placebo
groups were analyzed.Interventions In 2016, initial dosing
of gantenerumab, 225 mg (subcutaneously every 4 weeks) was
increased every 8 weeks up to 1200 mg. In 2017, initial
dosing of solanezumab, 400 mg (intravenously every 4 weeks)
was increased up to 1600 mg every 4 weeks.Main Outcomes and
Measures Longitudinal changes in CSF levels of neurogranin,
soluble triggering receptor expressed on myeloid cells 2
(sTREM2), chitinase 3–like 1 protein (YKL-40), glial
fibrillary acidic protein (GFAP), neurofilament light
protein (NfL), and plasma levels of GFAP and NfL.Results Of
236 eligible participants screened, 43 were excluded. A
total of 142 participants (mean [SD] age, 44 [10] years; 72
female $[51\%])$ were included in the study (gantenerumab,
52 $[37\%];$ solanezumab, 50 $[35\%];$ placebo, 40
$[28\%]).$ Relative to placebo, gantenerumab significantly
reduced CSF neurogranin level at year 4 (mean [SD]
β = −242.43 [48.04] pg/mL; P < .001); reduced
plasma GFAP level at year 1 (mean [SD]
β = −0.02 [0.01] ng/mL; P = .02), year 2 (mean
[SD] β = −0.03 [0.01] ng/mL; P = .002), and
year 4 (mean [SD] β = −0.06 [0.02] ng/mL;
P < .001); and increased CSF sTREM2 level at year 2
(mean [SD] β = 1.12 [0.43] ng/mL; P = .01) and
year 4 (mean [SD] β = 1.06 [0.52] ng/mL;
P = .04). Solanezumab significantly increased CSF NfL
(log) at year 4 (mean [SD] β = 0.14 [0.06];
P = .02). Correlation analysis for rates of change found
stronger correlations between CSF markers and fluid markers
with Pittsburgh compound B positron emission tomography for
solanezumab and placebo.Conclusions and Relevance This
randomized clinical trial supports the importance of
fibrillar amyloid reduction in multiple AD-related processes
of neuroinflammation and neurodegeneration in CSF and plasma
in DIAD. Additional studies of antiaggregated amyloid
therapies in sporadic AD and DIAD are needed to determine
the utility of nonamyloid biomarkers in determining disease
modification.</br><b>Key Points</b>Question How do
antiamyloid agents affect downstream biomarkers of
Alzheimer-related pathophysiology regarding their target
engagement with either soluble (solanezumab) or fibrillar
(gantenerumab) amyloid?Findings This phase 2/3 double-blind,
placebo-controlled, randomized clinical trial including 142
participants investigated gantenerumab and solanezumab in
individuals with gene variants for dominantly inherited
Alzheimer disease. Gantenerumab decreased cerebrospinal
fluid (CSF) neurogranin and plasma glial fibrillary acidic
protein levels while increasing CSF levels of soluble
triggering receptor expressed on myeloid cells 2; in
contrast, solanezumab treatment was associated with
increased CSF neurofilament light protein levels.Meaning
Antiamyloid agents removing fibrillar amyloid plaques
demonstrated effects on glial and postsynaptic fluid
biomarkers downstream of initial amyloid deposition, whereas
binding soluble amyloid-β was associated with increased
measures of neurodegeneration.},
cin = {AG Levin / AG Jucker / Clinical Research (Munich)},
ddc = {610},
cid = {I:(DE-2719)1111016 / I:(DE-2719)1210001 /
I:(DE-2719)1111015},
pnm = {353 - Clinical and Health Care Research (POF4-353) / 352 -
Disease Mechanisms (POF4-352)},
pid = {G:(DE-HGF)POF4-353 / G:(DE-HGF)POF4-352},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:38683602},
doi = {10.1001/jamaneurol.2024.0991},
url = {https://pub.dzne.de/record/269526},
}