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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090402
Recruitment Status : Completed
First Posted : August 26, 2004
Results First Posted : February 26, 2010
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE August 25, 2004
First Posted Date  ICMJE August 26, 2004
Results First Submitted Date  ICMJE December 2, 2009
Results First Posted Date  ICMJE February 26, 2010
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE April 2004
Actual Primary Completion Date January 3, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • F2-isoprostane Level Urine F2-Isoprostanes [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Oxidative Stress
  • Dementia
  • Hyperlipidemia
  • Inflammation
Intervention  ICMJE
  • Dietary Supplement: Fish Oil
    Fish oil capsule
    Other Name: Fish oil concentrate, omega-3 fatty acids
  • Dietary Supplement: Lipoic Acid
    Lipoic acid capsule
    Other Name: thiotic acid, alpha lipoic acid
  • Other: Fish Oil Placebo
    Soybean oil placebo capsule
    Other Name: Placebo (for fish oil)
  • Other: Lipoic Acid Placebo
    Lipoic acid (LA) placebo capsule containing no LA
    Other Name: Placebo (for lipoic acid)
Study Arms  ICMJE
  • Placebo Comparator: Fish Oil Placebo & Lipoic Acid Placebo
    Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram placebo-lipoic acid per day. Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil capsules. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
    Interventions:
    • Other: Fish Oil Placebo
    • Other: Lipoic Acid Placebo
  • Active Comparator: Fish Oil Only
    Three 1-gram fish oil concentrate capsules in triglyceride form (675 milligrams DHA and 975 milligrams EPA), 2 in the morning and 1 in the evening, plus one 600 milligram placebo-lipoic acid (containing no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate) per day.
    Interventions:
    • Dietary Supplement: Fish Oil
    • Other: Lipoic Acid Placebo
  • Experimental: Fish Oil Plus Lipoic Acid
    Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram lipoic acid (LA) capsule in the racemic form per day.
    Interventions:
    • Dietary Supplement: Fish Oil
    • Dietary Supplement: Lipoic Acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
39
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date January 3, 2006   (Final data collection date for primary outcome measure)
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00090402
Other Study ID Numbers  ICMJE IA0062
1R21AG023805-01 ( U.S. NIH Grant/Contract )
5R21AG023805-02 ( U.S. NIH Grant/Contract )
AG08017 ( Other Grant/Funding Number: National Institute of Aging )
M01RR000334 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lynne Shinto, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Lynne H. Shinto, ND Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date June 2017

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