2020
DOI: 10.14283/jpad.2020.68
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Abstract: Previous findings from the positron emission tomography (PET) substudy of the SCarlet RoAD and Marguerite RoAD open-label extension (OLE) showed gantenerumab doses up to 1200 mg every 4 weeks administered subcutaneously resulted in robust beta-amyloid (Aβ) plaque removal over 24 months in people with prodromal-to-moderate Alzheimer’s disease (AD). In this 36-month update, we demonstrate continued reduction, with mean (standard error) centiloid values at 36 months of -4.3 (7.5), 0.8 (6.7), and 4.7 (8.0) in the… Show more

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Cited by 20 publications
(21 citation statements)
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“…Gantenerumab demonstrated the capacity to lower brain amyloid plaques in patients with prodromal-to-moderate AD in the Phase 3 SCarlet RoAD (NCT01224106) and Marguerite RoAD (NCT02051608) open-label extension (OLE) studies, with continuous reduction of amyloid plaque levels below the amyloid positivity threshold at 36 months. 143 Patients received SC doses of up to 1200 mg gantenerumab every 4 weeks in the OLE studies, and the results informed the design of the GRADUATE 1 and 2 studies (NCT03444870 and NCT03443973, respectively), which are two parallel, global, placebo-controlled and randomized Phase 3 trials evaluating the safety and efficacy of gantenerumab in patients with early (prodromal to mild) AD. The primary endpoint of the studies is the change from baseline to Week 116 in Global Outcome, as measured by Clinical Dementia Rating-Sum of Boxes.…”
Section: Antibodies To Watch In 2022: Noncancer Indicationsmentioning
confidence: 99%
“…Gantenerumab demonstrated the capacity to lower brain amyloid plaques in patients with prodromal-to-moderate AD in the Phase 3 SCarlet RoAD (NCT01224106) and Marguerite RoAD (NCT02051608) open-label extension (OLE) studies, with continuous reduction of amyloid plaque levels below the amyloid positivity threshold at 36 months. 143 Patients received SC doses of up to 1200 mg gantenerumab every 4 weeks in the OLE studies, and the results informed the design of the GRADUATE 1 and 2 studies (NCT03444870 and NCT03443973, respectively), which are two parallel, global, placebo-controlled and randomized Phase 3 trials evaluating the safety and efficacy of gantenerumab in patients with early (prodromal to mild) AD. The primary endpoint of the studies is the change from baseline to Week 116 in Global Outcome, as measured by Clinical Dementia Rating-Sum of Boxes.…”
Section: Antibodies To Watch In 2022: Noncancer Indicationsmentioning
confidence: 99%
“…The only trial currently enrolling participants is the DIAN-TU trial, a phase II/III randomized, double-blind, placebo-controlled study which aims to assess whether IV infusion of solanezumab slows the rate of progression of cognitive impairment and improves disease-related biomarkers in individuals with mutations causing dominantly inherited AD (NCT01760005). In this parallel assignment study, solanezumab administered every 4 weeks at escalating doses will be compared with gantenerumab, which is a fully humanized IgG1 that has demonstrated high-affinity binding to cerebral Aβ and to significantly reduce Aβ plaques in both AD transgenic mouse models [ 68 ••] and after 2 years of treatment in humans [ 69 •]. Efficacy will be measured by the change from baseline in the DIAN-multivariate cognitive endpoint which consists of four measures: Wechsler Memory Scale-Revised Logical Memory Delayed Recall Test, Wechsler Adult Intelligence Sale Digit Symbol Substitution Test (WAIS), International Shopping List Task (ISLT), and MMSE.…”
Section: Introductionmentioning
confidence: 99%
“…Florbetapir PET was used to assess the efficacy of gantenerumab in Aβ plaque reduction. Earlier this year, Klein et al reported that subcutaneous gantenerumab doses up to 1200 mg continued to reduce Aβ plaque burden at 36 months following treatment initiation [ 68 ••].…”
Section: Introductionmentioning
confidence: 99%
“…AD is characterized by aggregation of amyloid beta (Aβ) plaques and tau neurofibrillary tangles (NFT). Clinical trials have attempted to reduce accumulation of these proteins in the brain and prevent further cognitive decline; however, although some amyloid antibody trials have successfully reduced plaque load, none have been successful to date in halting the progression of AD symptoms (2,3). Positron Emission Tomography (PET) measures AD pathology by quantifying the load of Aβ and NFT in the brain, and a number of studies have demonstrated relationships between PET measures and concentrations of these proteins in cerebral spinal fluid (CSF) (4,5).…”
mentioning
confidence: 99%