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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Inflammation; Alzheimer's Disease; Hyperlipidemia; Oxidative Stress; Dementia

Treatments: Dietary Supplement: Fish Oil; Other: Fish Oil Placebo; Dietary Supplement: Lipoic Acid; Other: Lipoic Acid Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00090402

1R21AG023805-01 (U.S. NIH Grant/Contract)

IA0062

M01RR000334 (U.S. NIH Grant/Contract)

AG08017 (Other Grant/Funding Number)

5R21AG023805-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 3 patient groups, including a placebo group

Fish Oil Placebo & Lipoic Acid Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Lipoic Acid Placebo

Other: Fish Oil Placebo

Fish Oil Only

Active Comparator group

Description:

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.

Treatment:

Other: Lipoic Acid Placebo

Dietary Supplement: Fish Oil

Fish Oil Plus Lipoic Acid

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipoic Acid

Dietary Supplement: Fish Oil