Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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Alzheimer's disease (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.

Official Title
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Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease

Conditions
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Alzheimer's Disease, Oxidative Stress, Dementia, Hyperlipidemia, Inflammation

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Lipoic Acid
* Other: Fish Oil Placebo
* Other: Lipoic Acid Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable Alzheimer's Disease or mild cognitive impairment Mini Mental State Examination (MMSE) score between 18 and 26 Clinical Dementia Rating (CDR) of 0.5 or 1.0 Fluent in English Exclusion Criteria: Use of lipid lowering medications Consumption of fish of more than twice a week Use of omega and alpha lipoic acid supplements Use of systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, or narcotic analgesics Depression Any other serious health conditions that may interfere with the study Enrollment in another clinical trial

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fish Oil Placebo & Lipoic Acid Placebo<br>Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram placebo-lipoic acid per day. Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil capsules. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate. | Other: Fish Oil Placebo<br>* Soybean oil placebo capsule<br>* Other names: Placebo (for fish oil);Other: Lipoic Acid Placebo<br>* Lipoic acid (LA) placebo capsule containing no LA<br>* Other names: Placebo (for lipoic acid);|
| Active Comparator: Fish Oil Only<br>Three 1-gram fish oil concentrate capsules in triglyceride form (675 milligrams DHA and 975 milligrams EPA), 2 in the morning and 1 in the evening, plus one 600 milligram placebo-lipoic acid (containing no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate) per day. | Dietary Supplement: Fish Oil<br>* Fish oil capsule<br>* Other names: Fish oil concentrate, omega-3 fatty acids;Other: Lipoic Acid Placebo<br>* Lipoic acid (LA) placebo capsule containing no LA<br>* Other names: Placebo (for lipoic acid);|
| Experimental: Fish Oil Plus Lipoic Acid<br>Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram lipoic acid (LA) capsule in the racemic form per day. | Dietary Supplement: Fish Oil<br>* Fish oil capsule<br>* Other names: Fish oil concentrate, omega-3 fatty acids;Dietary Supplement: Lipoic Acid<br>* Lipoic acid capsule<br>* Other names: thiotic acid, alpha lipoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F2-isoprostane Level Urine F2-Isoprostanes | F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples. | baseline, 12 months | 
| Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months | The MMSE is a measure of global cognitive function, and scores range from 0-30, with a lower score indicates greater cognitive impairment. | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months | The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks. | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish Oils, Thioctic Acid, Antioxidants, Dietary Supplements