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Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial.

ABSTRACT: Docosahexaenoic acid (DHA) is the most abundant long-chain polyunsaturated fatty acid in the brain. Epidemiological studies suggest that consumption of DHA is associated with a reduced incidence of Alzheimer disease. Animal studies demonstrate that oral intake of DHA reduces Alzheimer-like brain pathology.To determine if supplementation with DHA slows cognitive and functional decline in individuals with Alzheimer disease.A randomized, double-blind, placebo-controlled trial of DHA supplementation in individuals with mild to moderate Alzheimer disease (Mini-Mental State Examination scores, 14-26) was conducted between November 2007 and May 2009 at 51 US clinical research sites of the Alzheimer's Disease Cooperative Study.Participants were randomly assigned to algal DHA at a dose of 2 g/d or to identical placebo (60% were assigned to DHA and 40% were assigned to placebo). Duration of treatment was 18 months.Change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog) and change in the Clinical Dementia Rating (CDR) sum of boxes. Rate of brain atrophy was also determined by volumetric magnetic resonance imaging in a subsample of participants (n = 102).A total of 402 individuals were randomized and a total of 295 participants completed the trial while taking study medication (DHA: 171; placebo: 124). Supplementation with DHA had no beneficial effect on rate of change on ADAS-cog score, which increased by a mean of 7.98 points (95% confidence interval [CI], 6.51-9.45 points) for the DHA group during 18 months vs 8.27 points (95% CI, 6.72-9.82 points) for the placebo group (linear mixed-effects model: P = .41). The CDR sum of boxes score increased by 2.87 points (95% CI, 2.44-3.30 points) for the DHA group during 18 months compared with 2.93 points (95% CI, 2.44-3.42 points) for the placebo group (linear mixed-effects model: P = .68). In the subpopulation of participants (DHA: 53; placebo: 49), the rate of brain atrophy was not affected by treatment with DHA. Individuals in the DHA group had a mean decline in total brain volume of 24.7 cm(3) (95% CI, 21.4-28.0 cm(3)) during 18 months and a 1.32% (95% CI, 1.14%-1.50%) volume decline per year compared with 24.0 cm(3) (95% CI, 20-28 cm(3)) for the placebo group during 18 months and a 1.29% (95% CI, 1.07%-1.51%) volume decline per year (P = .79).Supplementation with DHA compared with placebo did not slow the rate of cognitive and functional decline in patients with mild to moderate Alzheimer disease.clinicaltrials.gov Identifier: NCT00440050.

SUBMITTER: Quinn JF

PROVIDER: S-EPMC3259852 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial.

Quinn Joseph F JF Raman Rema R Thomas Ronald G RG Yurko-Mauro Karin K Nelson Edward B EB Van Dyck Christopher C Galvin James E JE Emond Jennifer J Jack Clifford R CR Weiner Michael M Shinto Lynne L Aisen Paul S PS

JAMA 20101101 17

<h4>Context</h4>Docosahexaenoic acid (DHA) is the most abundant long-chain polyunsaturated fatty acid in the brain. Epidemiological studies suggest that consumption of DHA is associated with a reduced incidence of Alzheimer disease. Animal studies demonstrate that oral intake of DHA reduces Alzheimer-like brain pathology.<h4>Objective</h4>To determine if supplementation with DHA slows cognitive and functional decline in individuals with Alzheimer disease.<h4>Design, setting, and patients</h4>A r ...[more]

PMID: 21045096

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Project description:Blood levels of homocysteine may be increased in Alzheimer disease (AD) and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Even in the absence of vitamin deficiency, homocysteine levels can be reduced by administration of high-dose supplements of folic acid and vitamins B(6) and B(12). Prior studies of B vitamins to reduce homocysteine in AD have not had sufficient size or duration to assess their effect on cognitive decline.To determine the efficacy and safety of B vitamin supplementation in the treatment of AD.A multicenter, randomized, double-blind controlled clinical trial of high-dose folate, vitamin B(6), and vitamin B(12) supplementation in 409 (of 601 screened) individuals with mild to moderate AD (Mini-Mental State Examination scores between 14 and 26, inclusive) and normal folic acid, vitamin B(12), and homocysteine levels. The study was conducted between February 20, 2003, and December 15, 2006, at clinical research sites of the Alzheimer Disease Cooperative Study located throughout the United States.Participants were randomly assigned to 2 groups of unequal size to increase enrollment (60% treated with high-dose supplements [5 mg/d of folate, 25 mg/d of vitamin B(6), 1 mg/d of vitamin B(12)] and 40% treated with identical placebo); duration of treatment was 18 months.Change in the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog).A total of 340 participants (202 in active treatment group and 138 in placebo group) completed the trial while taking study medication. Although the vitamin supplement regimen was effective in reducing homocysteine levels (mean [SD], -2.42 [3.35] in active treatment group vs -0.86 [2.59] in placebo group; P < .001), it had no beneficial effect on the primary cognitive measure, rate of change in ADAS-cog score during 18 months (0.372 points per month for placebo group vs 0.401 points per month for active treatment group, P = .52; 95% confidence interval of rate difference, -0.06 to 0.12; based on the intention-to-treat generalized estimating equations model), or on any secondary measures. A higher quantity of adverse events involving depression was observed in the group treated with vitamin supplements.This regimen of high-dose B vitamin supplements does not slow cognitive decline in individuals with mild to moderate AD.clinicaltrials.gov Identifier: NCT00056225.

Project description:Study objectivesThis secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.MethodsOmega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.ResultsEighty-one percent (ntx = 156; nplacebo = 150) of children had 180-day trial outcome data; 68% (ntx = 134; nplacebo = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.ConclusionsAlthough there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.Clinical trial registrationRegistry: ClinicalTrials.gov; Identifier: NCT01576783.CitationBoone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.

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Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial.

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Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial.

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