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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090402
• Other study ID #: IA0062
• Secondary ID: 5R21AG0238055R21
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2004
• Last updated: February 3, 2010
• Start date: April 2004
• Est. completion date: February 2007

Study information

• Verified date: January 2010
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Hyperlipidemia
• Hyperlipidemias
• Inflammation
• Oxidative Stress

Intervention

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.
• 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:
• Placebo
Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F2-isoprostane Level Urine F2-Isoprostanes Were Collected.		12 months	No
Secondary	Activities of Daily Living		baseline, 6 months, 12 months	No