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

Phase 1

Completed

Conditions: Dementia
Oxidative Stress
Inflammation
Alzheimer's Disease
Hyperlipidemia

Interventions: Other: Fish Oil Placebo
Dietary Supplement: Fish Oil
Other: Lipoic Acid Placebo
Dietary Supplement: Lipoic Acid

Registration Number: NCT00090402

Lead Sponsor: Oregon Health and Science University

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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish Oil Placebo & Lipoic Acid Placebo	Fish Oil Placebo	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.
Fish Oil Only	Fish Oil	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.
Fish Oil Plus Lipoic Acid	Fish Oil	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.
Fish Oil Placebo & Lipoic Acid Placebo	Lipoic Acid Placebo	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.
Fish Oil Plus Lipoic Acid	Lipoic Acid	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.
Fish Oil Only	Lipoic Acid Placebo	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.

Primary Outcome Measures

Name	Time	Method
F2-isoprostane Level Urine F2-Isoprostanes	baseline, 12 months	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.
Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months	baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months	baseline, 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.