NCT00090402

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

February 26, 2010

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

August 25, 2004

Results QC Date

December 2, 2009

Last Update Submit

June 21, 2017

Conditions

Alzheimer's DiseaseOxidative StressDementiaHyperlipidemiaInflammation

Keywords

Fish OilsThioctic AcidAntioxidantsDietary Supplements

Outcome Measures

Primary Outcomes (2)

  • F2-isoprostane Level Urine F2-Isoprostanes

    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.

    baseline, 12 months

  • Change in Mini-Mental State Exam (MMSE) Score From Baseline to 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.

    baseline, 12 months

Secondary Outcomes (1)

  • Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months

    baseline, 12 months

Study Arms (3)

Fish Oil Placebo & Lipoic Acid Placebo

PLACEBO COMPARATOR

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.

Other: Fish Oil PlaceboOther: Lipoic Acid Placebo

Fish Oil Only

ACTIVE COMPARATOR

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.

Dietary Supplement: Fish OilOther: Lipoic Acid Placebo

Fish Oil Plus Lipoic Acid

EXPERIMENTAL

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.

Dietary Supplement: Fish OilDietary Supplement: Lipoic Acid

Interventions

Fish OilDIETARY_SUPPLEMENT

Fish oil capsule

Also known as: Fish oil concentrate, omega-3 fatty acids
Fish Oil OnlyFish Oil Plus Lipoic Acid
Lipoic AcidDIETARY_SUPPLEMENT

Lipoic acid capsule

Also known as: thiotic acid, alpha lipoic acid
Fish Oil Plus Lipoic Acid
Fish Oil PlaceboOTHER

Soybean oil placebo capsule

Also known as: Placebo (for fish oil)
Fish Oil Placebo & Lipoic Acid Placebo
Lipoic Acid PlaceboOTHER

Lipoic acid (LA) placebo capsule containing no LA

Also known as: Placebo (for lipoic acid)
Fish Oil OnlyFish Oil Placebo & Lipoic Acid Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

  • 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. doi: 10.1016/j.neuron.2004.08.013.

    PMID: 15339646BACKGROUND

  • 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. doi: 10.1001/archneur.60.7.940.

    PMID: 12873849BACKGROUND

  • 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. doi: 10.3233/jad-2003-5306.

    PMID: 12897407BACKGROUND

  • Shinto L, Quinn J, Montine T, Dodge HH, Woodward W, Baldauf-Wagner S, Waichunas D, Bumgarner L, Bourdette D, Silbert L, Kaye J. A randomized placebo-controlled pilot trial of omega-3 fatty acids and alpha lipoic acid in Alzheimer's disease. J Alzheimers Dis. 2014;38(1):111-20. doi: 10.3233/JAD-130722.

    PMID: 24077434RESULT

MeSH Terms

Conditions

Alzheimer DiseaseDementiaHyperlipidemiasInflammation

Interventions

Fish OilsFatty Acids, Omega-3Thioctic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFatty Acids, UnsaturatedFatty AcidsCarboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and Coenzymes

Results Point of Contact

Title
Lynne Shinto, ND, MPH
Organization
Oregon Health & Science University
shintol@ohsu.edu
503-494-5035

Study Officials

  • Lynne H. Shinto, ND

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ND, MPH

Study Record Dates

First Submitted

August 25, 2004

First Posted

August 26, 2004

Study Start

April 1, 2004

Primary Completion

January 3, 2006

Study Completion

August 1, 2007

Last Updated

July 21, 2017

Results First Posted

February 26, 2010

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)