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Alzheimer's DiseasePhase 1/2NCT00090402

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

A Phase 1/2 study testing Fish Oil and Lipoic Acid in people with Alzheimer's Disease and Oxidative Stress, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer's Disease, Oxidative Stress, Dementia
What is being tested?
Fish Oil and Lipoic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
Apr 2004to Aug 2007
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease

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).

Read the 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.

Being tested
Fish Oil, Lipoic Acid, Fish Oil Placebo, Lipoic Acid Placebo
Keywords
Fish Oils, Thioctic Acid, Antioxidants, Dietary Supplements
Medical subject headings
Alzheimer Disease, Dementia, Hyperlipidemias, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fish OilDietary supplement

    Also called Fish oil concentrate, omega-3 fatty acids

    Fish oil capsule

  • Lipoic AcidDietary supplement

    Also called thiotic acid, alpha lipoic acid

    Lipoic acid capsule

  • Fish Oil PlaceboOther

    Also called Placebo (for fish oil)

    Soybean oil placebo capsule

  • Lipoic Acid PlaceboOther

    Also called Placebo (for lipoic acid)

    Lipoic acid (LA) placebo capsule containing no LA

Study groups in NCT00090402
Study groupRoleWhat they receive
Fish Oil Placebo & Lipoic Acid PlaceboPlacebo comparatorThree 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.
Receives: Other: Fish Oil Placebo; Other: Lipoic Acid Placebo
Fish Oil OnlyActive comparatorThree 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.
Receives: Dietary Supplement: Fish Oil; Other: Lipoic Acid Placebo
Fish Oil Plus Lipoic AcidExperimentalThree 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.
Receives: Dietary Supplement: Fish Oil; Dietary Supplement: Lipoic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 12 months

  2. 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.

    Measured: baseline, 12 months

Secondary outcomes (1)

  1. Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 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.

    Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2004 (estimated)
  2. Study startApr 2004
  3. Primary completion3 Jan 2006
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00090402
Sponsor's protocol ID
IA0062
Other IDs
1R21AG023805-01, 5R21AG023805-02, AG08017, M01RR000334
Status last verified
Jun 2017
First submitted
25 Aug 2004
Last updated
21 Jul 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15339646

  • 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.

    PubMed 12873849

  • 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.

    PubMed 12897407

  • 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.

    PubMed 24077434

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fish Oil and Lipoic Acid in people with Alzheimer's Disease and Oxidative Stress, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

F2-isoprostane Level Urine F2-Isoprostanes (time frame: baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00090402, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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