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

This study has been completed.

First Received: August 25, 2004 Last Updated: September 26, 2007 History of Changes

Sponsor:	National Institute on Aging (NIA)
Collaborator:	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

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

Resource links provided by NLM:

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

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

National Institute on Aging (NIA)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Lynne H. Shinto, ND

Oregon Health and Science University

More Information

Publications:

Calon F, Lim GP, Yang F, Morihara T, Teter B, Ubeda O, Rostaing P, Triller A, Salem N Jr, Ashe KH, Frautschy SA, Cole GM. Docosahexaenoic acid protects from dendritic pathology in an Alzheimer's disease mouse model. Neuron. 2004 Sep 2;43(5):633-45.

Morris MC, Evans DA, Bienias JL, Tangney CC, Bennett DA, Wilson RS, Aggarwal N, Schneider J. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol. 2003 Jul;60(7):940-6.

Lovell MA, Xie C, Xiong S, Markesbery WR. Protection against amyloid beta peptide and iron/hydrogen peroxide toxicity by alpha lipoic acid. J Alzheimers Dis. 2003 Jun;5(3):229-39.

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

Keywords provided by National Institute on Aging (NIA):

Fish Oils
Thioctic Acid
Antioxidants
Dietary Supplements

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurodegenerative Diseases
Brain Diseases
Pathologic Processes
Mental Disorders
Vitamins
Micronutrients
Dementia
Dyslipidemias
Hyperlipidemias
Metabolic Diseases

Vitamin B Complex
Growth Substances
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Protective Agents
Pharmacologic Actions
Inflammation
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Thioctic Acid
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010