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NCT Number: NCT00090402

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

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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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Dyslipidemias Hyperlipidemia Hyperlipidemias Inflammation Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Fish oil capsule

Other names: Fish oil concentrate, omega-3 fatty acids

Lipoic Acid

Dietary Supplement

Lipoic acid capsule

Other names: thiotic acid, alpha lipoic acid

Fish Oil Placebo

Other

Soybean oil placebo capsule

Other names: Placebo (for fish oil)

Lipoic Acid Placebo

Other

Lipoic acid (LA) placebo capsule containing no LA

Other names: Placebo (for lipoic acid)

Primary outcomes

  1. F2-isoprostane Level Urine F2-Isoprostanes

    Time frame: 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.

  2. Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months

    Time frame: 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 outcomes

  1. Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Aug 26, 2004
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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