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Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
This study has been completed.
Sponsors and Collaborators: National Institute on Aging (NIA)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00090402
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation
Drug: Fish oil
Drug: Alpha lipoic acid
Phase I
Phase II

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Antioxidants Dementia
Drug Information available for: Thioctic acid Fish oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 39
Study Start Date: April 2004
Estimated Study Completion Date: February 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090402

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
Principal Investigator: Lynne H. Shinto, ND Oregon Health and Science University
  More Information

Publications:
Study ID Numbers: IA0062, 5R21AG023805-02
Study First Received: August 25, 2004
Last Updated: September 26, 2007
ClinicalTrials.gov Identifier: NCT00090402  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Fish Oils
Thioctic Acid
Antioxidants
Dietary Supplements

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Alzheimer Disease
Stress
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Inflammation
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Metabolic disorder
Dementia
Thioctic Acid
Dyslipidemias
Lipid Metabolism Disorders
Delirium

Additional relevant MeSH terms:
Antioxidants
Vitamin B Complex
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Tauopathies
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009