Delayed-start analysis: Mild Alzheimer’s disease patients in solanezumab trials, 3.5 years
نویسندگان
چکیده
Introduction: Solanezumab is an anti-amyloid monoclonal antibody in clinical testing for treatment H.L.-S., E.S., K.C ployees and minor sha the Alzheimer’s Assoc for the Alzheimer’s A Lilly and Company an full-time employee of Therapies, Biogen, Bi Hoffman LaRoche, M ences, Suven, Transiti imental agents and rec CME program; she has entech, Lilly/NIA, Me http://dx.doi.org/10.1
منابع مشابه
A Novel Approach to Delayed-Start Analyses for Demonstrating Disease-Modifying Effects in Alzheimer’s Disease
One method for demonstrating disease modification is a delayed-start design, consisting of a placebo-controlled period followed by a delayed-start period wherein all patients receive active treatment. To address methodological issues in previous delayed-start approaches, we propose a new method that is robust across conditions of drug effect, discontinuation rates, and missing data mechanisms. ...
متن کاملQuantile regression to characterize solanezumab effects in Alzheimer's disease trials
INTRODUCTION In two solanezumab trials for mild-to-moderate Alzheimer's disease (AD) dementia, 27% of patients had biomarker confirmation of amyloid status. Of these, approximately 25% of mild patients and approximately 10% of moderate patients were amyloid negative and, as a group, did not exhibit clinical progression typical of AD. This post-hoc analysis describes a statistical surrogate for ...
متن کاملA Fresh Look at the Alzheimer’s Disease Clinical Research Year
The world’s leading Alzheimer’s disease (AD) clinical researchers wrapped up the fifth international conference in Clinical Trials on Alzheimer’s Disease (CTAD) today in Monaco after identifying several pathways to possible interventions. In particular, a pair of complementary and dynamic talks centered around the phase III clinical trials of the compounds bapineuzemab (Pfizer) and solanezumab ...
متن کاملRight lateral prefrontal cortex — specificity for inhibition or strategy use ?
Cohen AD, Price JC, Weissfeld LA, James J, Rosario BL, Bi W, et al. Basal cerebral metabolism may modulate the cognitive effects of Abeta in mild cognitive impairment: an example of brain reserve. J Neurosci 2009; 29: 14770–8. Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, et al. Phase 3 trials of solanezumab for mild-tomoderate Alzheimer’s disease. N Engl J Med 2014; 370: 311–21...
متن کاملPhase 3 solanezumab trials: Secondary outcomes in mild Alzheimer's disease patients
INTRODUCTION EXPEDITION and EXPEDITION2 were identically designed placebo-controlled phase 3 studies assessing effects of solanezumab, an antiamyloid monoclonal antibody binding soluble amyloid-β peptide, on cognitive and functional decline over 80 weeks in patients with mild-to-moderate Alzheimer's disease (AD). Primary findings for both studies have been published. METHODS Secondary analyse...
متن کامل