ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease

This study has been completed.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
Official Title  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  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Alzheimer's Disease
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation
Intervention  Drug: Fish oil
Drug: Alpha lipoic acid
MEDLINE PMIDs 15339646,   12873849,   12897407
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  39
Start Date  April 2004
Completion Date February 2007
Eligibility 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
Gender Both
Ages 55 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00090402
Organization ID IA0062
Secondary IDs †† 5R21AG023805-02
Study Sponsor  National Institute on Aging (NIA)
Collaborators †† National Center for Complementary and Alternative Medicine (NCCAM)
Investigators 
Principal Investigator:     Lynne H. Shinto, ND     Oregon Health and Science University    
Information Provided By National Institute on Aging (NIA)
Verification Date September 2007
First Received Date  August 25, 2004
Last Updated Date September 26, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers