A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer’s disease
Open accessAbstract
Dominantly inherited Alzheimer's disease (DIAD) causes predictable biological changes decades before the onset of clinical symptoms, enabling testing of interventions in the asymptomatic and symptomatic stages to delay or slow disease progression. We conducted a randomized, placebo-controlled, multi-arm trial of gantenerumab or solanezumab in participants with DIAD across asymptomatic and symptomatic disease stages. Mutation carriers were assigned 3:1 to either drug or placebo and received treatment for 4-7 years. The primary outcome was a cognitive end point; secondary outcomes included clinical, cognitive, imaging and fluid biomarker measures. Fifty-two participants carrying a mutation were assigned to receive gantenerumab, 52 solanezumab and 40 placebo. Both drugs engaged their Aβ targets but neither demonstrated a beneficial effect on cognitive measures compared to controls. The solanezumab-treated group showed a greater cognitive decline on some measures and did not show benefits on downstream biomarkers. Gantenerumab significantly reduced amyloid plaques, cerebrospinal fluid total tau, and phospho-tau181 and attenuated increases of neurofilament light chain. Amyloid-related imaging abnormalities edema was observed in 19.2% (3 out of 11 were mildly symptomatic) of the gantenerumab group, 2.5% of the placebo group and 0% of the solanezumab group. Gantenerumab and solanezumab did not slow cognitive decline in symptomatic DIAD. The asymptomatic groups showed no cognitive decline; symptomatic participants had declined before reaching the target doses.
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Prevention trials in dominantly inherited Alzheimer's disease have been helped by fluid and molecular PET biomarkers that measure treatment-related changes in AD pathology and neurodegeneration.
“Prevention trials in DIAD have also been facilitated by fluid and molecular PET imaging biomarkers that allow for the measurement of treatment-related changes in AD pathologies and neurodegeneration.8”
From Temporal order of clinical and biomarker changes in familial frontotemporal dementia (2022) · cites this paper as [8]
Two articles reported the results of NCT03887455, and the other two reported the results of NCT01760005.
“Two articles reported the results of NCT03887455 [43, 84], and the other two reported the results of NCT01760005 [53, 83].”
From Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update (2023) · cites this paper as [53]
Both trials NCT03887455 and NCT01760005 had an overall low risk of bias.
“Both trials (NCT03887455 and NCT01760005) had a overall low risk of bias [43, 53, 83, 84].”
From Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update (2023) · cites this paper as [53]
In the DIAN-TU-001 trial, gantenerumab significantly reduced amyloid plaques, CSF total tau, and phospho-tau181 and attenuated increases in neurofilament light chain.
“whereas gantenerumab significantly reduced amyloid plaques, CSF total tau, and phospho-tau181 and attenuated increases in neurofilament light chain [53].”
From Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update (2023) · cites this paper as [53]
In the DIAN-TU-001 trial, solanezumab treatment did not exert any beneficial effects on downstream biomarkers.
“and that solanezumab treatment did not exert any beneficial effects on downstream biomarkers”
From Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update (2023) · cites this paper as [53]
In the DIAN-TU-001 trial, the solanezumab-treated group had greater cognitive decline on some measures relative to placebo.
“The results indicated that the solanezumab-treated group had greater cognitive decline on some measures relative to placebo”
From Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update (2023) · cites this paper as [53]
Gantenerumab treatment significantly reduced amyloid loads and normalized CSF Aβ42 levels.
“Gantenerumab treatment significantly reduced the amyloid loads and normalized CSF Aβ42 levels.338”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [338]
Gantenerumab had a positive impact on reduction of cortical amyloid, leading to further study by an exploratory open-label extension.
“The data showed that gantenerumab had a positive impact on the reduction of cortical amyloid, leading to its further study by an exploratory open-label extension (OLE).338”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [338]
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- Authors
- Salloway, S., Farlow, M., McDade, E., Clifford, D. B., Wang, G., Llibre-Guerra, J. J., Hitchcock, J. M., Mills, S. L., Santacruz, A. M., Aschenbrenner, A. J., Hassenstab, J., Benzinger, T. L. S., Gordon, B. A., Fagan, A. M., Coalier, K. A., Cruchaga, C., Goate, A. A., Perrin, R. J., Xiong, C., Li, Y., Morris, J. C., Snider, B. J., Mummery, C., Surti, G. M., Hannequin, D., Wallon, D., Berman, S. B., Lah, J. J., Jimenez-Velazquez, I. Z., Roberson, E. D., van Dyck, C. H., Honig, L. S., Sánchez-Valle, R., Brooks, W. S., Gauthier, S., Galasko, D. R., Masters, C. L., Brosch, J. R., Hsiung, G.-Y. R., Jayadev, S., Formaglio, M., Masellis, M., Clarnette, R., Pariente, J., Dubois, B., Pasquier, F., Jack, C. R., Koeppe, R., Snyder, P. J., Aisen, P. S., Thomas, R. G., Berry, S. M., Wendelberger, B. A., Andersen, S. W., Holdridge, K. C., Mintun, M. A., Yaari, R., Sims, J. R., Baudler, M., Delmar, P., Doody, R. S., Fontoura, P., Giacobino, C., Kerchner, G. A., Bateman, R. J., the Dominantly Inherited Alzheimer Network–Trials Unit, Formaglio, M., Mills, S. L., Pariente, J., & van Dyck, C. H.
- Affiliations
- Brown University (US)
- Indiana University School of Medicine (US)
- Washington University in St. Louis (US)
- Icahn School of Medicine at Mount Sinai (US)
- University College London (GB)
- Centre Hospitalier Universitaire de Rouen (FR)
- University of Pittsburgh Medical Center (US)
- Emory University (US)
- University of Alabama at Birmingham (US)
- Columbia University Irving Medical Center (US)
- UNSW Sydney (AU)
- McGill University (CA)
- University of California San Diego (US)
- The University of Melbourne (AU)
- University of British Columbia (CA)
- University of Washington (US)
- Sunnybrook Health Science Centre (CA)
- The University of Western Australia (AU)
- Pitié-Salpêtrière Hospital (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Mayo Clinic (US)
- University of Michigan (US)
- University of Rhode Island (US)
- University of Southern California (US)
- Berry Consultants, LLC (United States) (US)
- Eli Lilly (United States) (US)
- F. Hoffmann-La Roche AG (CH)
- Hospices Civils de Lyon (FR)
- Corresponding author
- Bateman, Randall J.
- ORCID
- Salloway, Stephen
- Farlow, Martin
- McDade, Eric
- Clifford, David B.
- Wang, Guoqiao
- Llibre-Guerra, Jorge J.
- Santacruz, Anna M.
- Aschenbrenner, Andrew J.
- Hassenstab, Jason
- Benzinger, Tammie L. S.
- Gordon, Brian A.
- Fagan, Anne M.
- Cruchaga, Carlos
- Goate, Alison A.
- Perrin, Richard J.
- Xiong, Chengjie
- Li, Yan
- Morris, John C.
- Mummery, Catherine
- Hannequin, Didier
- Wallon, David
- Berman, Sarah B.
- Lah, James J.
- Roberson, Erik D.
- Honig, Lawrence S.
- Sánchez-Valle, Raquel
- Brooks, William S.
- Gauthier, Serge
- Galasko, Douglas R.
- Masters, Colin L.
- Brosch, Jared R.
- Hsiung, Ging-Yuek Robin
- Jayadev, Suman
- Masellis, Mario
- Dubois, Bruno
- Pasquier, Florence
- Jack, Clifford R.
- Koeppe, Robert
- Snyder, Peter J.
- Thomas, Ronald G.
- Berry, Scott M.
- Wendelberger, Barbara A.
- Andersen, Scott W.
- Holdridge, Karen C.
- Sims, John R.
- Delmar, Paul
- Fontoura, Paulo
- Kerchner, Geoffrey A.
- Bateman, Randall J.
- Venue
- Nature Medicine
- Published
- 2021-06-21
- Volume
- 27
- Issue
- 7
- Pages
- 1187-1196
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- PMC
- PMC8988051
- OpenAlex
- W3176983361
- Cited by
- 359
- References
- 59
- Citations by year
- 2026: 25 · 2025: 72 · 2024: 74 · 2023: 79 · 2022: 96 · 2021: 13
- FWCI
- 41.26
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Nature Medicine (publishedVersion)
- UWA Profiles and Research Repository (UWA) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- HAL (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- U.S. Department of Health & Human Services | NIH | National Institute on Aging (U01AG042791, U01AG042791-S1, R01AG046179, R01AG053267-S1, U19AG032438)
- Alzheimer’s Association
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Neurology › Amyotrophic Lateral Sclerosis Research
- Keywords
- gantenerumab, solanezumab, cognitive decline, amyloid plaques, cerebrospinal fluid biomarkers, tau protein, neurofilament light chain, amyloid-related imaging abnormalities, asymptomatic mutation carriers, early intervention
- MeSH terms
- Adult, Alzheimer Disease, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Placebos, Biomarkers, Amyloid beta-Peptides, Disease Progression, Antibodies, Monoclonal, Humanized
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