Completed

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

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What is being tested

Fish Oil

+ Lipoic Acid Placebo

+ Lipoic Acid

Dietary SupplementOther
Who is being recruted

Alzheimer Disease+12

+ Mental Disorders

+ Brain Diseases

Over 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorOregon Health and Science University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

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 TitleFish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease 
NCT00090402
Principal SponsorOregon Health and Science University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaHyperlipidemiasInflammationMetabolic DiseasesNervous System DiseasesPathologic ProcessesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesDyslipidemiasLipid Metabolism Disorders

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
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.

Group II

Experimental
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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Oregon Health and Science University

Portland, United StatesSee the location
CompletedOne Study Center