Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
NCT ID: NCT00090402
Last Updated: 2017-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2004-04-30
2007-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Fish Oil Placebo
Soybean oil placebo capsule
Lipoic Acid Placebo
Lipoic acid (LA) placebo capsule containing no LA
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.
Fish Oil
Fish oil capsule
Lipoic Acid Placebo
Lipoic acid (LA) placebo capsule containing no LA
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.
Fish Oil
Fish oil capsule
Lipoic Acid
Lipoic acid capsule
Interventions
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Fish Oil
Fish oil capsule
Lipoic Acid
Lipoic acid capsule
Fish Oil Placebo
Soybean oil placebo capsule
Lipoic Acid Placebo
Lipoic acid (LA) placebo capsule containing no LA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
National Center for Research Resources (NCRR)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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Lynne Shinto
ND, MPH
Principal Investigators
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Lynne H. Shinto, ND
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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AG08017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IA0062
Identifier Type: -
Identifier Source: org_study_id
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