Post Hoc Evidence for an Additive Effect of Memantine and Donepezil: Consistent Findings from DOMINO-AD Study and Memantine Clinical Trial Program.
J Prev Alzheimers Dis
; 2(3): 165-171, 2015.
Article
em En
| MEDLINE
| ID: mdl-29226942
ABSTRACT
BACKGROUND:
Several randomized trials have demonstrated superiority of memantine-cholinesterase inhibitor combination therapy in patients with moderate to severe Alzheimer's disease, yet a recent publication reported no additional benefit of add-on memantine therapy compared to donepezil alone.OBJECTIVES:
In this post hoc analysis, we sought to re-evaluate the results from the DOMINO study using common statistical tools and to apply the statistical models used in the DOMINO study to a pooled data set of 24- to 28-week randomized trials of memantine in patients with moderate to severe AD in order to explore the robustness of the primary findings from the DOMINO study.DESIGN:
DOMINO study Randomized, double-blind, placebo-controlled trial (Current Controlled Trial number, ISRCTN49545035); Memantine Clinical Trial Program Pooled analysis from four randomized, double-blind, placebo-controlled trials.SETTING:
DOMINO study United Kingdom; Memantine Clinical Trial Program Multinational.PARTICIPANTS:
DOMINO study 295 participants enrolled during the period of February 2008 to March 2010; Memantine Clinical Trial Program 1417 participants enrolled between August 1998 and January 2008. MEASUREMENTS In the DOMINO study, the co-primary outcome measures were scores on the Standardized Mini-Mental State Examination and the Bristol Activities of Daily Living Scale; Neuropsychiatric Inventory was a secondary measure. In the Memantine Clinical Trial Program, outcome measures included the Severe Impairment Battery, the 19-item Alzheimer's Disease Cooperative Study - Activities of Daily Living scale, Neuropsychiatric Inventory, and a 4-Domain Composite Index (Z-score; a post hoc assessment).RESULTS:
Both the pooled analysis of the Memantine Clinical Trial Program and the re-assessment of the DOMINO study with common statistical tools showed that adding memantine to donepezil therapy is associated with benefits across multiple clinical domains.CONCLUSIONS:
The current analyses suggest that the results of the DOMINO study do not contradict previous studies which investigated the combined effects of memantine-cholinesterase inhibitor treatment.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Prognostic_studies
Idioma:
En
Revista:
J Prev Alzheimers Dis
Ano de publicação:
2015
Tipo de documento:
Article