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

Oregon Health and Science University39 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease Oxidative Stress Dementia Hyperlipidemia Inflammation

Interventions

Fish OilDIETARY_SUPPLEMENT

Fish oil capsule

Lipoic AcidDIETARY_SUPPLEMENT

Lipoic acid capsule

Fish Oil PlaceboOTHER

Soybean oil placebo capsule

Lipoic Acid Placebo

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: baseline, 12 months

Secondary Outcomes

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.

Time frame: baseline, 12 months

Data from ClinicalTrials.gov

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