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

Tracking Information

First Received Date ^ICMJE

August 25, 2004

Last Updated Date

September 26, 2007

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00090402 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alzheimer's Disease
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation

Intervention ^ICMJE

Drug: Fish oil
Drug: Alpha lipoic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00090402

Responsible Party

Study ID Numbers ^ICMJE

IA0062, 5R21AG023805-02

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Lynne H. Shinto, ND

Oregon Health and Science University

Information Provided By

National Institute on Aging (NIA)

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP