title: Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease.
abstract: Souvenaid® (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.
  
  
  
  To determine effect sizes observed in clinical trials of Souvenaid and to calculate the number needed to treat to show benefit or harm.
  
  
  
  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 Cramér'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.
  
  
  
  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.
  
  
  
  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.
authors: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
authors: Jeffrey
authors: J
authors: Cummings
authors: Alzheimer Center and Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
authors: Philip
authors: P
authors: Scheltens
authors: Biomedical Research Building, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.
authors: Ian
authors: I
authors: McKeith
authors: Department of Neurology, Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Sant Antoni M. Claret, Barcelona, Spain.
authors: Rafael
authors: R
authors: Blesa
authors: Alzheimer Center and Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.|Metis Cognition Ltd, Park House, Kilmington Common, Wiltshire, UK.
authors: John E
authors: JE
authors: Harrison
authors: Behaviour Neurology Section - Universidade Federal de São Paulo, São Paulo Sp, Brazil.
authors: Paulo H F
authors: PH
authors: Bertolucci
authors: Department of Medicine, Dalhousie University, Halifax, NS, Canada.|Divisions of Geriatric Medicine and Neurology, Dalhousie University, Halifax, NS, Canada.|Department of Geriatric Medicine and Institute of Brain, Behaviour and Neurosciences, University of Manchester, Oxford Road, Manchester, UK.|DGI Clinical, Halifax, NS, Canada.
authors: Kenneth
authors: K
authors: Rockwood
authors: MARC, University of Southampton, Southampton, UK.
authors: David
authors: D
authors: Wilkinson
authors: Auxiliis BV, Amsterdam, The Netherlands.
authors: Wouter
authors: W
authors: Wijker
authors: Department of Neurologic Sciences and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.
authors: David A
authors: DA
authors: Bennett
authors: Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.
authors: Raj C
authors: RC
authors: Shah
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000178:diet therapy* / Q000503:physiopathology; D014150:Antipsychotic Agents / Q000008:administration & dosage; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; D005260:Female; D005500:Follow-Up Studies; D055951:Functional Food; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011569:Psychiatric Status Rating Scales; D012044:Regression Analysis; D012643:Selenium; D016896:Treatment Outcome; D014815:Vitamins
chemical_list: D014150:Antipsychotic Agents; D014815:Vitamins; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; D012643:Selenium
keywords: Alzheimer’s disease; Souvenaid; effect size; number-needed-to-treat