Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease
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 cl...
| Published in: | Journal of Alzheimer's Disease |
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| Main Authors: | , , , , , , , , , , |
| Format: | Article in Journal/Newspaper |
| Language: | English |
| Published: |
Ios Press
2017
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| Subjects: | |
| Online Access: | https://repositorio.unifesp.br/handle/11600/56518 https://doi.org/10.3233/JAD-160745 |
| Summary: | 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. National Institute of General Medical Sciences Keep Memory Alive Nutricia Research, on behalf of Nutricia Advanced Medical Nutrition NL Food & Nutrition Delta project, FND Cleveland Clin, Lou Ruvo Ctr Brain Hlth, 888W Bonneville Ave, Las Vegas, NV 89106 USA Vrije Univ Amsterdam, Med Ctr, Alzheimer Ctr, Neurosci Campus Amsterdam, Amsterdam, Netherlands Vrije Univ Amsterdam, Med Ctr, Dept Neurol, Neurosci Campus Amsterdam, Amsterdam, Netherlands Newcastle Univ, Biomed Res Bldg,Campus Ageing & Vital, Newcastle Upon Tyne, Tyne & Wear, England Autonomous Univ Barcelona, Hosp Santa Creu & St Pau, Dept Neurol, Barcelona, Spain Metis Cognit Ltd, Pk House, Kilmington Common, Wilts, England Univ Fed Sao Paulo, Behav Neurol Sect, Sao Paulo, SP, Brazil 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 Univ Southampton, MARC, Southampton, Hants, England Auxiliis BV, Amsterdam, Netherlands Rush Univ, Dept Neurol Sci, Med Ctr, Chicago, IL 60612 USA Rush Univ, Rush Alzheimers Dis Ctr, Med Ctr, Chicago, IL 60612 USA Rush Univ, Dept Family Med, Med Ctr, Chicago, IL 60612 USA Behaviour Neurology Section – Universidade Federal de São Paulo, São Paulo Sp, Brazil National Institute of General Medical Sciences: P20GM109025 NL Food & Nutrition Delta project, FND: 10003 Web of Science |
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