A phase III randomized trial of gantenerumab in prodromal Alzheimer’s disease
Open accessAbstract
BACKGROUND: Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). METHODS: In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection. The primary endpoint was the change from baseline to week 104 in Clinical Dementia Rating Sum of Boxes (CDR-SB) score. We evaluated treatment effects on cerebrospinal fluid biomarkers (all patients) and amyloid positron emission tomography (substudy). A futility analysis was performed once 50% of patients completed 2 years of treatment. Safety was assessed in patients who received at least one dose. RESULTS: Of the 3089 patients screened, 797 were randomized. The study was halted early for futility; dosing was discontinued; and the study was unblinded. No differences between groups in the primary (least squares mean [95% CI] CDR-SB change from baseline 1.60 [1.28, 1.91], 1.69 [1.37, 2.01], and 1.73 [1.42, 2.04] for placebo, gantenerumab 105 mg, and gantenerumab 225 mg, respectively) or secondary clinical endpoints were observed. The incidence of generally asymptomatic amyloid-related imaging abnormalities increased in a dose- and APOE ε4 genotype-dependent manner. Exploratory analyses suggested a dose-dependent drug effect on clinical and biomarker endpoints. CONCLUSIONS: The study was stopped early for futility, but dose-dependent effects observed in exploratory analyses on select clinical and biomarker endpoints suggest that higher dosing with gantenerumab may be necessary to achieve clinical efficacy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01224106 . Registered on October 14, 2010.
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In a small exploratory study, gantenerumab at 200 mg showed evidence of amyloid removal of about 20 centiloids compared with baseline.
“In this small exploratory study, there was evidence for the removal of amyloid compared to baseline (~20 CL) at the 200 mg dose”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [63]
Open-label gantenerumab produced a dramatic decline in Aβ deposition, with some participants becoming amyloid negative on imaging.
“Follow-up analyses demonstrated a dramatic decline in Aβ deposition in participants in the open extension, such that some became amyloid negative on imaging.”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Ostrowitzki et al., 2017
A new high-dose gantenerumab phase 3 trial was initiated in very mild to mild Alzheimer disease.
“Based on this, a new high dose phase 3 trial has been initiated in very mild to mild AD (Ostrowitzki et al., 2017).”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Ostrowitzki et al., 2017
Many ongoing mAbs trials are in phase 3, including aducanumab, gantenerumab, and BAN2401 in prodromal and very mild AD.
“Many ongoing mAbs trials are in phase 3, including aducanumab,67 gantenerumab,68 and BAN240169 in prodromal and very mild AD”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [69]
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Alzheimer’s Disease Clinical Trials: Moving Toward Successful Prevention
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- Authors
- for the SCarlet RoAD Investigators, Ostrowitzki, S., Lasser, R. A., Dorflinger, E., Scheltens, P., Barkhof, F., Nikolcheva, T., Ashford, E., Retout, S., Hofmann, C., Delmar, P., Klein, G., Andjelkovic, M., Dubois, B., Boada, M., Blennow, K., Santarelli, L., & Fontoura, P.
- Affiliations
- Genentech (US)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- UCL Queen Square Institute of Neurology (GB)
- F. Hoffmann-La Roche AG (CH)
- Assistance Publique – Hôpitaux de Paris (FR)
- Corresponding author
- Fontoura, Paulo
- ORCID
- Venue
- Alzheimer's Research & Therapy
- Published
- 2017-12
- Volume
- 9
- Issue
- 1
- Pages
- 95-95
- ISSN
- 1758-9193 (ISSN-L)
- PMC
- PMC5723032
- OpenAlex
- W2772872651
- Cited by
- 567
- References
- 31
- Citations by year
- 2026: 23 · 2025: 52 · 2024: 82 · 2023: 72 · 2022: 84 · 2021: 83 · 2020: 96 · 2019: 50 · 2018: 23 · 2017: 1
- FWCI
- 34.41
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-09-27)
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Alzheimer s Research & Therapy (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- HAL (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UCL Discovery (University College London) (submittedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- F. Hoffmann-La Roche
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- gantenerumab, prodromal Alzheimer's disease, amyloid plaques, anti-amyloid monoclonal antibodies, Fc receptor-mediated phagocytosis, amyloid-related imaging abnormalities, APOE ε4, dose-dependent effects, cerebrospinal fluid biomarkers, amyloid PET, CDR-SB
- MeSH terms
- Aged, Alzheimer Disease, Antibodies, Monoclonal, Dose-Response Relationship, Drug, Double-Blind Method, Humans, Immunologic Factors, Longitudinal Studies, Magnetic Resonance Imaging, Middle Aged, Neuropsychological Tests, Psychiatric Status Rating Scales, Amyloid beta-Peptides, Treatment Outcome, Positron-Emission Tomography, Apolipoprotein E4, Antibodies, Monoclonal, Humanized, Prodromal Symptoms
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