Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease
Por:
Cummings, J, Scheltens, P, McKeith, I, Blesa, R, Harrison, JE, Bertolucci, PHF, Rockwood, K, Wilkinson, D, Wijker, W, Bennett, DA, Shah, RC
Publicada:
1 ene 2017
Resumen:
Background: Souvenaid (R) (uridine monophosphate, docosahexaenoic acid, eicosapentaenoic acid, choline, phospholipids, folic acid, vitamins B12, B6, C, and E, and selenium), was developed to support the formation and function of neuronal membranes.
Objective: To determine effect sizes observed in clinical trials of Souvenaid and to calculate the number needed to treat to show benefit or harm.
Methods: Data from all three reported randomized controlled trials of Souvenaid in Alzheimer's disease (AD) dementia (Souvenir I, Souvenir II, and S-Connect) and an open-label extension study were included in analyses of effect size for cognitive, functional, and behavioral outcomes. Effect size was determined by calculating Cohen's d statistic (or Cramer's V method for nominal data), number needed to treat and number needed to harm. Statistical calculations were performed for the intent-to-treat populations.
Results: In patients with mild AD, effect sizes were 0.21 (95% confidence intervals: -0.06, 0.49) for the primary outcome in Souvenir II (neuropsychological test battery memory z-score) and 0.20 (0.10, 0.34) for the co-primary outcome of Souvenir I (Wechsler memory scale delayed recall). No effect was shown on cognition in patients with mild-to-moderate AD (S-Connect). The number needed to treat (6 and 21 for Souvenir I and II, respectively) and high number needed to harm values indicate a favorable harm: benefit ratio for Souvenaid versus control in patients with mild AD.
Conclusions: The favorable safety profile and impact on outcome measures converge to corroborate the putative mode of action and demonstrate that Souvenaid can achieve clinically detectable effects in patients with early AD.
Filiaciones:
Cummings, J:
Cleveland Clin, Lou Ruvo Ctr Brain Hlth, 888W Bonneville Ave, Las Vegas, NV 89106 USA
Scheltens, P:
Vrije Univ Amsterdam, Med Ctr, Alzheimer Ctr, Neurosci Campus Amsterdam, Amsterdam, Netherlands
Vrije Univ Amsterdam, Med Ctr, Dept Neurol, Neurosci Campus Amsterdam, Amsterdam, Netherlands
McKeith, I:
Newcastle Univ, Biomed Res Bldg,Campus Ageing & Vital, Newcastle Upon Tyne, Tyne & Wear, England
Blesa, R:
Autonomous Univ Barcelona, Hosp Santa Creu & St Pau, Dept Neurol, Barcelona, Spain
Harrison, JE:
Vrije Univ Amsterdam, Med Ctr, Alzheimer Ctr, Neurosci Campus Amsterdam, Amsterdam, Netherlands
Vrije Univ Amsterdam, Med Ctr, Dept Neurol, Neurosci Campus Amsterdam, Amsterdam, Netherlands
Metis Cognit Ltd, Pk House, Kilmington Common, Wilts, England
Bertolucci, PHF:
Univ Fed Sao Paulo, Behav Neurol Sect, Sao Paulo, SP, Brazil
Rockwood, K:
Dalhousie Univ, Dept Med, Halifax, NS, Canada
Dalhousie Univ, Div Geriatr Med, Halifax, NS, Canada
Dalhousie Univ, Dept Neurol, Halifax, NS, Canada
Univ Manchester, Dept Geriatr Med, Oxford Rd, Oxford, England
Univ Manchester, Inst Brain Behav & Neurosci, Oxford Rd, Oxford, England
DGI Clin, Halifax, NS, Canada
Wilkinson, D:
Univ Southampton, MARC, Southampton, Hants, England
Wijker, W:
Auxiliis BV, Amsterdam, Netherlands
Bennett, DA:
Rush Univ, Dept Neurol Sci, Med Ctr, Chicago, IL 60612 USA
Rush Univ, Rush Alzheimers Dis Ctr, Med Ctr, Chicago, IL 60612 USA
Shah, RC:
Rush Univ, Rush Alzheimers Dis Ctr, Med Ctr, Chicago, IL 60612 USA
Rush Univ, Dept Family Med, Med Ctr, Chicago, IL 60612 USA
Green Published, Bronze
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