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| Descriptive Information Fields | |||||
| Brief Title † | Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease | ||||
| Official Title † | Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Alzheimer's Disease Oxidative Stress Dementia Hyperlipidemia Inflammation |
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| Intervention † | Drug: Fish oil Drug: Alpha lipoic acid |
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| MEDLINE PMIDs | 15339646, 12873849, 12897407 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 39 | ||||
| Start Date † | April 2004 | ||||
| Completion Date | February 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00090402 | ||||
| Organization ID | IA0062 | ||||
| Secondary IDs †† | 5R21AG023805-02 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | August 25, 2004 | ||||
| Last Updated Date | September 26, 2007 | ||||