A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease

作者：Remington Ruth; Bechtel Cynthia; Larsen David; Samar Annemarie; Doshanjh Laura; Fishman Paul; Luo Yuan; Smyers Kathleen; Page Robert; Morrell Christopher; Shea Thomas B^*

来源：Journal of Alzheimer's Disease, 2015, 45(2): 395-405.

DOI：10.3233/JAD-142499

• Acetyl-L-carnitine
• Alzheimer's disease
• B vitamins
• behavioral difficulties
• cognitive decline
• N-acetyl cysteine
• nutrition
• supplement
• S-adenosyl methionine
• vitamin E

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.

• 出版日期2015