Delayed-start analysis: Mild Alzheimer's disease patients in solanezumab trials, 3.5 years
| Autor: | Ilya Lipkovich, Christopher Carlson, Gopalan Sethuraman, Paul S. Aisen, Hong Liu-Seifert, Karen C. Holdridge, Sharon L. Hoog, Rachelle S. Doody, Roza Hayduk, Scott W. Andersen, Eric Siemers |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Gerontology
medicine.medical_specialty Activities of daily living business.industry Disease Delayed-start Featured Article Alzheimer's disease Placebo Placebo group 3. Good health Clinical trial Psychiatry and Mental health Clinical trials Secondary analysis Internal medicine medicine Solanezumab Neurology (clinical) Disease assessment Anti-amyloid-β antibody business medicine.drug |
| Zdroj: | Alzheimer's & Dementia : Translational Research & Clinical Interventions |
| ISSN: | 2352-8737 |
| Popis: | Introduction Solanezumab is an anti-amyloid monoclonal antibody in clinical testing for treatment of Alzheimer's disease (AD). Its mechanism suggests the possibility of slowing the progression of AD. Methods A possible disease-modifying effect of solanezumab was assessed using a new statistical method including noninferiority testing. Performance differences were compared during the placebo-controlled period with performance differences after the placebo patients crossed over to solanezumab in the delayed-start period. Results Noninferiority of the 14-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 14 ) and Alzheimer's Disease Cooperative Study Activities of Daily Living inventory instrumental items (ADCS-iADL) differences was met through 132 weeks, indicating that treatment differences observed in the placebo-controlled period remained, within a predefined margin, after the placebo group initiated solanezumab. Solanezumab was well tolerated, and no new safety concerns were identified. Discussion The results of this secondary analysis show that the mild subgroup of solanezumab-treated patients who initiated treatment early, at the start of the placebo-controlled period, retained an advantage at most time points in the delayed-start period. |
| Databáze: | OpenAIRE |
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