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Sponsors and Collaborators: |
National Institute on Aging (NIA) National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00090402 |
The purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of Alzheimer's Disease (AD).
Condition | Intervention | Phase |
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Alzheimer's Disease Oxidative Stress Dementia Hyperlipidemia Inflammation |
Drug: Fish oil Drug: Alpha lipoic acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease |
Estimated Enrollment: | 39 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | February 2007 |
AD is a serious condition associated with increased inflammation, cholesterol, and oxidative stress (a condition involving an excess of free radicals and a decrease in antioxidant levels). Fish oil and alpha lipoic acid, which have few side effects, may help relieve these problems; therefore, these supplements may slow the progression of AD, particularly when given in combination. This study will evaluate the effect of fish oil and alpha lipoic acid on inflammation, lipid levels, and oxidative stress.
Participants in this study will be randomly assigned to receive fish oil alone, fish oil and alpha lipoic acid, or placebo for 1 year. AD rating scales as well as urine and blood tests will be used to assess participants. Participants will have monthly clinic visits during the study to monitor adverse events and to undergo various laboratory tests.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Lynne H. Shinto, ND | Oregon Health and Science University |
Study ID Numbers: | IA0062, 5R21AG023805-02 |
Study First Received: | August 25, 2004 |
Last Updated: | September 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00090402 |
Health Authority: | United States: Federal Government |
Fish Oils Thioctic Acid Antioxidants Dietary Supplements |
Metabolic Diseases Hyperlipidemias Alzheimer Disease Stress Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Inflammation |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Metabolic disorder Dementia Thioctic Acid Dyslipidemias Lipid Metabolism Disorders Delirium |
Antioxidants Vitamin B Complex Pathologic Processes Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Nervous System Diseases Micronutrients Tauopathies Protective Agents Pharmacologic Actions |