ω-3 Fatty Acid Treatment in 174 Patients With Mild to Moderate Alzheimer Disease: OmegAD Study: A Randomized Double-blind Trial
Abstract
BACKGROUND: Epidemiologic and animal studies have suggested that dietary fish or fish oil rich in omega-3 fatty acids, for example, docosahexaenoic acid and eicosapentaenoic acid, may prevent Alzheimer disease (AD). OBJECTIVE: To determine effects of dietary omega-3 fatty acid supplementation on cognitive functions in patients with mild to moderate AD. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. PARTICIPANTS: Two hundred four patients with AD (age range [mean +/- SD], 74 +/- 9 years) whose conditions were stable while receiving acetylcholine esterase inhibitor treatment and who had a Mini-Mental State Examination (MMSE) score of 15 points or more were randomized to daily intake of 1.7 g of docosahexaenoic acid and 0.6 g of eicosapentaenoic acid (omega-3 fatty acid-treated group) or placebo for 6 months, after which all received omega-3 fatty acid supplementation for 6 months more. MAIN OUTCOME MEASURES: The primary outcome was cognition measured with the MMSE and the cognitive portion of the Alzheimer Disease Assessment Scale. The secondary outcome was global function as assessed with the Clinical Dementia Rating Scale; safety and tolerability of omega-3 fatty acid supplementation; and blood pressure determinations. RESULTS: One hundred seventy-four patients fulfilled the trial. At baseline, mean values for the Clinical Dementia Rating Scale, MMSE, and cognitive portion of the Alzheimer Disease Assessment Scale in the 2 randomized groups were similar. At 6 months, the decline in cognitive functions as assessed by the latter 2 scales did not differ between the groups. However, in a subgroup (n = 32) with very mild cognitive dysfunction (MMSE >27 points), a significant (P<.05) reduction in MMSE decline rate was observed in the omega-3 fatty acid-treated group compared with the placebo group. A similar arrest in decline rate was observed between 6 and 12 months in this placebo subgroup when receiving omega-3 fatty acid supplementation. The omega-3 fatty acid treatment was safe and well tolerated. CONCLUSIONS: Administration of omega-3 fatty acid in patients with mild to moderate AD did not delay the rate of cognitive decline according to the MMSE or the cognitive portion of the Alzheimer Disease Assessment Scale. However, positive effects were observed in a small group of patients with very mild AD (MMSE >27 points).
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A subgroup of patients with very mild impairment experienced a significant reduction in the rate of cognitive decline.
“However, a subgroup of patients with very mild impairment experienced a significant reduction in the rate of cognitive decline.”
From Role of n-3 long-chain polyunsaturated fatty acids in human nutrition and health: Review of recent studies and recommendations (2021) · cites this paper as [85]
In the OmegaAD trial, daily supplementation with 1,700 mg DHA and 600 mg EPA for 6 months in 174 older adults with mild to moderate Alzheimer's disease failed to slow down the rate of cognitive decline from placebo.
“In the OmegaAD trial, daily supplementation with 1,700 mg DHA and 600 mg EPA for 6 months in 174 older adults with mild to moderate AD also failed to slow down the rate of cognitive decline from that obtained in the placebo group [85].”
From Role of n-3 long-chain polyunsaturated fatty acids in human nutrition and health: Review of recent studies and recommendations (2021) · cites this paper as [85]
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- Authors
- Freund-Levi, Y., Eriksdotter-Jönhagen, M., Cederholm, T., Basun, H., Faxén-Irving, G., Garlind, A., Vedin, I., Vessby, B., Wahlund, L.-O., & Palmblad, J.
- Venue
- Archives of Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2006-10-01
- Volume
- 63
- Issue
- 10
- Pages
- 1402
- ISSN
- 0003-9942 (ISSN-L)
- OpenAlex
- W2109348896
- Cited by
- 751
- References
- 29
- Citations by year
- 2026: 12 · 2025: 31 · 2024: 24 · 2023: 19 · 2022: 32 · 2021: 32 · 2020: 44 · 2019: 41 · 2018: 31 · 2017: 47 · 2016: 37 · 2015: 49 · 2014: 53 · 2013: 44 · 2012: 42
- FWCI
- 34.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Neurology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Keywords
- omega-3 fatty acids, docosahexaenoic acid, eicosapentaenoic acid, fish oil supplementation, Alzheimer's disease, cognitive decline, dietary supplementation, acetylcholinesterase inhibitors, Clinical Dementia Rating, Mini-Mental State Examination, tolerability
- MeSH terms
- Aged, Alzheimer Disease, Blood Pressure, Brain, Cognition Disorders, Double-Blind Method, Female, Humans, Male, Middle Aged, Fatty Acids, Omega-3, Placebo Effect, Treatment Outcome, Disease Progression, Neuroprotective Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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