Background: Gantenerumab is a fully human anti-amyloid-β (Aβ) immunoglobulin G1 monoclonal antibody for subcutaneous (SC) administration. The efficacy and safety of low-dose (105 mg or 225 mg) gantenerumab were investigated in SCarlet RoAD (SR; NCT01224106), a Phase III, double-blind (DB), placebo-controlled study in participants with prodromal Alzheimer's disease. Following a pre-planned futility analysis, SR was converted into an open-label extension (OLE) study.
View Article and Find Full Text PDFBackground: Second-generation tau tracers for positron emission tomography (PET) show high affinity for paired helical filaments tau deposits characteristic of Alzheimer´s disease and low off-target binding. Differences in their chemical structure though may lead to variations in their regional tau uptake and off-target signal. In this work, we aimed to compare the in-vivo uptake of tau tracers [F]PI-2620 and [F]RO948 in the early stages of the AD continuum.
View Article and Find Full Text PDFJ Biomed Mater Res B Appl Biomater
December 2024
Previous studies report rare occurrences of tibial baseplate fractures following primary total knee arthroplasty (TKA). However, at a microstructural scale, it remains unclear how fatigue models developed in vitro apply to fractures in vivo. In this study, we asked: (1) do any clinical factors differentiate fracture patients from a broader revision sample; and (2) in vivo, how does microstructure influence fatigue crack propagation? We identified three fractured tibial baseplates from an institutional review board exempt implant retrieval program.
View Article and Find Full Text PDFImportance: Data from 2 phase 3 studies of gantenerumab, GRADUATE I/II, and their open-label extensions represent a resource to further characterize amyloid-related imaging abnormalities (ARIA), including long-term sequelae.
Objectives: To describe the characteristics of ARIA and risk factors and clinical consequences of ARIA-edema (ARIA-E).
Design, Setting, And Participants: Secondary data collection from the GRADUATE I/II phase 3 randomized, double-blind, placebo-controlled, 116-week parallel-group studies and their open-label extensions, including PostGraduate, with up to 210 (mean, 125) weeks of total gantenerumab treatment were conducted between 2018 and 2023.
Aims: To evaluate a mobile app that delivers mental health support to adults with type 1 diabetes (T1D) living in rural and remote communities using the Reach, Effectiveness, Adoption, Intervention fidelity, Maintenance (RE-AIM) framework.
Methods: This study recruited 46 adults to participate in a 6-month intervention using REACHOUT, a mobile app that delivers peer-led mental health support (one-on-one, group-based texting and face-to-face virtual). Baseline and 6-month assessments measured diabetes distress (DD), depressive symptoms and perceived support (from family/friends, health care team and peers) along with other RE-AIM metrics.