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

This study has been completed.

Study NCT00090402 Information provided by Oregon Health and Science University

First Received on August 25, 2004. Last Updated on February 3, 2010 History of Changes

Results First Received: December 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Alzheimer's Disease Oxidative Stress Dementia Hyperlipidemia Inflammation
Interventions:	Dietary Supplement: Fish Oil Dietary Supplement: Fish Oil and Lipoic acid Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
Fish Oil	Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
Fish Oil Plus Lipoic Acid	Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.

Participant Flow: Overall Study

	Placebo	Fish Oil	Fish Oil Plus Lipoic Acid
STARTED	13	13	13
COMPLETED	11	11	12
NOT COMPLETED	2	2	1
Death	1	1	0
subject moved	1	0	0
stopped taking study medication	0	1	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
Fish Oil	Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
Fish Oil Plus Lipoic Acid	Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.

Baseline Measures

	Placebo	Fish Oil	Fish Oil Plus Lipoic Acid	Total
Number of Participants [units: participants]	13	13	13	39
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	2	1	3	6
>=65 years	11	12	10	33
Age [units: years] Mean ± Standard Deviation	75.9 ± 9.7	75.2 ± 10.8	76.7 ± 10.6	75.9 ± 9.7
Gender [units: participants]
Female	7	8	6	21
Male	6	5	7	18
Region of Enrollment [units: participants]
United States	13	13	13	39

Outcome Measures

1. Primary:

F2-isoprostane Level Urine F2-Isoprostanes Were Collected. [ Time Frame: 12 months ]

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2. Secondary:

Activities of Daily Living [ Time Frame: baseline, 6 months, 12 months ]

Results not yet posted. Anticipated Posting Date: 01/2010 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
phone: 503-494-5035
e-mail: shintol@ohsu.edu

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00090402 History of Changes
Other Study ID Numbers:	IA0062, 5R21AG023805, 5R21AG023805-02
Study First Received:	August 25, 2004
Results First Received:	December 2, 2009
Last Updated:	February 3, 2010
Health Authority:	United States: Federal Government