Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease - Full Text View

Sponsor:	Oregon Health and Science University
Collaborators:	National Institute on Aging (NIA) National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	Oregon Health and Science University
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	Dietary Supplement: Fish Oil Dietary Supplement: Fish Oil and Lipoic acid Other: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Dietary Supplements

Drug Information available for: Thioctic Acid Docosahexaenoic acids Eicosapentaenoic acid Fish oil

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

F2-isoprostane Level Urine F2-Isoprostanes Were Collected. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Activities of Daily Living [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Placebo Comparator: Placebo	Other: Placebo Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months.
Experimental: Fish Oil Fish oil concentrate	Dietary Supplement: Fish Oil Fish oil concentrate (daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) taken for 12 months. Other Name: Fish oil concentrate, omega-3 fatty acids
Experimental: Fish Oil and Lipoic Acid	Dietary Supplement: Fish Oil and Lipoic acid Fish oil concentrate(daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) plus lipoic acid (daily dose 600 milligrams)taken for 12 months Other Name: thiotic acid, alpha lipoic acid

Detailed Description:

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.

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

Oregon Health and Science University

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.

ClinicalTrials.gov Identifier:	NCT00090402 History of Changes
Other Study ID Numbers:	IA0062, 5R21AG023805, 5R21AG023805-02
Study First Received:	August 25, 2004
Results First Received:	December 2, 2009
Last Updated:	February 3, 2010
Health Authority:	United States: Federal Government

Keywords provided by Oregon Health and Science University:

Fish Oils
Thioctic Acid
Antioxidants
Dietary Supplements

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Hyperlipidemias
Inflammation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Pathologic Processes
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012