title: A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease.
abstract: BACKGROUND
  Increasing evidence points toward the efficacy of nutritional modifications in delaying cognitive decline and mood/behavioral difficulties in Alzheimer's disease (AD). Nutritional supplementation with individual agents has shown varied results suggesting the need for combinatorial intervention.
  
  
  OBJECTIVE
  We set out to determine whether nutritional intervention could positively impact cognitive performance and behavioral difficulties for individuals diagnosed with AD.
  
  
  METHODS
  A double-blind, multi-site, phase II study (ClinicalTrials.gov NCT01320527; Alzheimer's Association Trialmatch) was conducted in which 106 individuals with AD were randomized to a nutraceutical formulation (NF; folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or placebo for 3 or 6 months, followed by an open-label extension where participants received NF for 6 additional months.
  
  
  RESULTS
  The NF cohort improved versus the placebo cohort within 3 months (Clox-1 p = 0.0083, 95%CI [0.4481, 2.9343]; Dementia Rating Scale p = 0.0266, 95%CI [0.1722, 2.7171]). Caregivers reported non-significant improvements in Neuropsychiatric Inventory. Both cohorts improved or maintained baseline performance during open-label extensions. Activities of Daily Living did not change for either cohort.
  
  
  CONCLUSIONS
  These findings extend phase I studies where NF maintained or improved cognitive performance and mood/behavior.
authors.affiliation: University of Massachusetts Lowell, Lowell, MA, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Remington
authors.affiliation: Framingham State University, Framingham, MA, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Bechtel
authors.affiliation: Advanced Memory Dynamics, Layton, UT, USA.
authors.forename: David
authors.initials: D
authors.lastname: Larsen
authors.affiliation: Worcester State University, Worcester, MA, USA.
authors.forename: Annemarie
authors.initials: A
authors.lastname: Samar
authors.affiliation: Loyola University Maryland, Baltimore, MD, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Doshanjh
authors.affiliation: University of Maryland, College Park, MD, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Fishman
authors.affiliation: University of Maryland, College Park, MD, USA.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Luo
authors.affiliation: University of Massachusetts Lowell, Lowell, MA, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Smyers
authors.affiliation: Framingham State University, Framingham, MA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Page
authors.affiliation: Loyola University Maryland, Baltimore, MD, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Morrell
authors.affiliation: University of Massachusetts Lowell, Lowell, MA, USA.
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Shea
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications*; D017028:Caregivers / Q000523:psychology; D003072:Cognition Disorders / Q000178:diet therapy* / Q000209:etiology*; D015331:Cohort Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000178:diet therapy* / Q000209:etiology*; D013997:Time Factors; D014805:Vitamin B 12 / Q000008:administration & dosage; D024502:alpha-Tocopherol / Q000008:administration & dosage
chemical_list: D005492:Folic Acid; D024502:alpha-Tocopherol; D014805:Vitamin B 12
keywords: Acetyl-L-carnitine; Alzheimer's disease; B vitamins; N-acetyl cysteine; S-adenosyl methionine; behavioral difficulties; cognitive decline; nutrition; supplement; vitamin E