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

Phase 1

Completed

• Conditions: Dementia; Oxidative Stress; Inflammation; Alzheimer's Disease; Hyperlipidemia

• Registration Number: NCT00090402
• Lead Sponsor: Oregon Health and Science University

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

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-25
• Study First Posted: 2004-08-26
• Primary Completion: 2006-01-03
• Study Completion: 2007-08
• Results First Submitted: 2009-12-02
• Results First Submitted QC: 2010-02-03
• Results First Posted: 2010-02-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
F2-isoprostane Level Urine F2-Isoprostanes	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.
Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months	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 Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States