An alternative method for estimating efficacy of the AN1792 vaccine for Alzheimer disease
| Autor: | M. Grundman, S. Gilman, R. S. Black, N. C. Fox, M. Koller, T.D. Koepsell, Y.-Y. Chi, E.M. Ramos, W.W. Lee, W.A. Kukull |
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| Přispěvatelé: | Neurology, Neuroscience Campus Amsterdam 2008 |
| Rok vydání: | 2008 |
| Předmět: |
Endpoint Determination
Placebo group Antibodies Central nervous system disease Alzheimer Disease Outcome Assessment Health Care Medicine Humans Alternative methods Clinical Trials as Topic Vaccines biology business.industry Antibody titer Immunotherapy Active medicine.disease Placebo Effect Titer Antibody response Treatment Outcome Data Interpretation Statistical Immunology biology.protein Neurology (clinical) Antibody Alzheimer's disease business |
| Zdroj: | Grundman, M, Gilman, S, Black, R S, Fox, N C & Koller, M 2008, ' An alternative method for estimating efficacy of the AN1792 vaccine for Alzheimer disease ', Neurology, vol. 71, no. 9, pp. 697-698 . https://doi.org/10.1212/01.wnl.0000325484.81127.15 Neurology, 71(9), 697-698. Lippincott Williams and Wilkins |
| ISSN: | 0028-3878 |
| Popis: | Koepsell et al.1 suggest an alternative method for analyzing the phase 2a AN1792 studies.2,3 The original analysis compared immunized patients who mounted a prospectively defined antibody response (titer greater than or equal to 1:2,200) to all placebo-treated patients. The authors propose that these immunized antibody responders be compared to hypothetical responders in the placebo group (patients who would have responded to therapy if treated with AN1792). In this comparison, the authors assumed that the mean outcome among the hypothetical nonresponders in the placebo-treated group is equivalent to the mean outcome in immunized nonresponders (immunized patients with antibody titers less than 1:2,200). This assumption requires that there were no biological treatment effects in the immunized nonresponders on the outcomes being compared. However, as the authors acknowledge, the assumption of no biological effects in the immunized nonresponders is questionable. Based upon preclinical and early clinical data, patients in the original phase 2a study were defined as antibody responders if a titer of at least 1:2,200 occurred, but it cannot be assumed that lower titers yielded no biological activity in immunized patients.2 We reported significant correlations of neuropsychological tests and measures of brain volume with antibody titers below 1:2,200 (dose-response).2–3 Moreover, some … |
| Databáze: | OpenAIRE |
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