DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease

NCT00440050 | Completed Phase 3 Results DMC

• 3 other identifiers: IA00991RC2AG036535ADC-027-DHA
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 51

Brief Summary

The purpose of this study is to determine whether chronic DHA (Docosahexaenoic Acid) supplementation slows the progression of cognitive and functional decline in mild to moderate Alzheimer's disease (AD).

Conditions

Alzheimer's Disease

Keywords

fish oil; omega-3 fatty acids; EPA

Outcome Measures

Primary Outcomes (2)

• Rate of Change on the ADAS-Cog 11.

  ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.

  Baseline, 6, 12, 18 months

• Rate of Change on CDR-SOB

  CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.

  18 months

Secondary Outcomes (2)

• ADCS-ADL

  18 months

• Neuropsychiatric Inventory (NPI)

  18 months

Study Arms (2)

1.

EXPERIMENTAL

DHA

Drug: DHA (Docosahexaenoic Acid)

2.

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DHA (Docosahexaenoic Acid) DRUG

950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months

Also known as: Neuromins

1.

Placebo DRUG

2 placebo capsules twice a day for 18 months

2.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• years of age or older
• Residing in the community at baseline (includes assisted living facilities, but excludes long-term care nursing facilities)
• MMSE (Mini-Mental State Examination) at screen of 14-26 (inclusive)
• No medical contraindications to study participation
• Fluent in English or Spanish
• Corrected vision and hearing sufficient for compliance with testing procedures
• Supervision available for study medication
• Caregiver/study partner to accompany participant to all visits
• Study partner must have direct contact with the participant more than 2 days/week
• Able to ingest oral medication
• Daily DHA consumption less than or equal to 200 mg/day in prior two months estimated by an abbreviated DHA food frequency questionnaire
• Neuroimaging consistent with the diagnosis of AD at some time after the onset of the memory decline
• Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the investigator
• Stable use of cholinesterase inhibitors and memantine is permitted if doses are stable for 4 months prior to enrollment

You may not qualify if:

• Non-AD dementia
• Residence in a long-term care facility at baseline
• History of clinically significant stroke
• Modified Hachinski Ischemia score ≥ 4
• Current evidence or history in past two years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
• Sensory impairment which would prevent subject from participating in or cooperating with the protocol
• Use of another investigational agent within two months
• Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular (including history of ventricular fibrillation or ventricular tachycardia), pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
• Active neoplastic disease (skin tumors other than melanoma may be included; participants with stable prostate cancer may be included at the discretion of the Project Director)

Sponsors & Collaborators

• Alzheimer's Disease Cooperative Study (ADCS): lead
• National Institute on Aging (NIA): collaborator
• DSM Nutritional Products, Inc.: collaborator

Study Sites (51)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Sun Health Research Institute/Arizona Consortium

Sun City, Arizona, 85351, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

UCSD Shiley-Marcos Alzheimer's Research Center

La Jolla, California, 92037, United States

Location

University of Southern California Psychiatry and Behavioral Sciences

Los Angeles, California, 90033, United States

Location

UCLA Neurology

Los Angeles, California, 90095, United States

Location

Palo Alto Institute for Research & Education

Palo Alto, California, 94304, United States

Location

UC-Davis Alzheimer's Disease Center

Sacramento, California, 95817, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center, Dept. of Neurology

Washington D.C., District of Columbia, 20057, United States

Location

Howard University College of Medicine

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Wien Center

Miami Beach, Florida, 33140, United States

Location

University of South Florida Suncoast Alzheimer's and Gerontology Center

Tampa, Florida, 33617, United States

Location

Byrd Alzheimer's Institute

Tampa, Florida, 33647, United States

Location

Emory University Dept. of Psychiatry

Atlanta, Georgia, 30322, United States

Location

Northwestern University Cognitive Neurology and Alzheimer Disease Center

Chicago, Illinois, 60611, United States

Location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, Lexington, Sanders-Brown Center on Aging/Neurology

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University Division of Cognitive Neuroscience

Baltimore, Maryland, 20205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University Alzheimer's Disease Clinical and Research Program

Boston, Massachusetts, 02118, United States

Location

University of Michigan Dept. of Neurology

Ann Arbor, Michigan, 48105, United States

Location

Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic Rochester, Alzheimer's Disease Research Center

Rochester, Minnesota, 55905, United States

Location

Saint Louis University, Department of Psychiatry

St Louis, Missouri, 63104, United States

Location

Washington University ADRC-Memory and Aging Project

St Louis, Missouri, 63108, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Dent Neurological Institute

Amherst, New York, 14226, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Mount Sinai School of Medicine

The Bronx, New York, 10468, United States

Location

Wake Forest University Health Services

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University Memory and Aging Center

Cleveland, Ohio, 44120, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University Neurology

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital Neurology

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

University of Texas Southwestern-Memory Research Unit

Dallas, Texas, 75390, United States

Location

Baylor University Department of Neurology

Houston, Texas, 77030, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

University of Washington/Seattle Institute for Biomedical & Clinical Research

Seattle, Washington, 98108, United States

Location

University of Wisconsin Department of Medicine

Madison, Wisconsin, 53705, United States

Location

Related Publications (8)

• Horrocks LA, Farooqui AA. Docosahexaenoic acid in the diet: its importance in maintenance and restoration of neural membrane function. Prostaglandins Leukot Essent Fatty Acids. 2004 Apr;70(4):361-72. doi: 10.1016/j.plefa.2003.12.011.

  PMID: 15041028 BACKGROUND

• Kalmijn S, van Boxtel MP, Ocke M, Verschuren WM, Kromhout D, Launer LJ. Dietary intake of fatty acids and fish in relation to cognitive performance at middle age. Neurology. 2004 Jan 27;62(2):275-80. doi: 10.1212/01.wnl.0000103860.75218.a5.

  PMID: 14745067 BACKGROUND

• 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: 12873849 BACKGROUND

• Suzuki H, Morikawa Y, Takahashi H. Effect of DHA oil supplementation on intelligence and visual acuity in the elderly. World Rev Nutr Diet. 2001;88:68-71. doi: 10.1159/000059767. No abstract available.

  PMID: 11935973 BACKGROUND

• 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: 15339646 BACKGROUND

• Lim GP, Calon F, Morihara T, Yang F, Teter B, Ubeda O, Salem N Jr, Frautschy SA, Cole GM. A diet enriched with the omega-3 fatty acid docosahexaenoic acid reduces amyloid burden in an aged Alzheimer mouse model. J Neurosci. 2005 Mar 23;25(12):3032-40. doi: 10.1523/JNEUROSCI.4225-04.2005.

  PMID: 15788759 BACKGROUND

• Yassine HN, Rawat V, Mack WJ, Quinn JF, Yurko-Mauro K, Bailey-Hall E, Aisen PS, Chui HC, Schneider LS. The effect of APOE genotype on the delivery of DHA to cerebrospinal fluid in Alzheimer's disease. Alzheimers Res Ther. 2016 Jun 30;8:25. doi: 10.1186/s13195-016-0194-x.

  PMID: 27358067 DERIVED

• Quinn JF, Raman R, Thomas RG, Yurko-Mauro K, Nelson EB, Van Dyck C, Galvin JE, Emond J, Jack CR Jr, Weiner M, Shinto L, Aisen PS. Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial. JAMA. 2010 Nov 3;304(17):1903-11. doi: 10.1001/jama.2010.1510.

  PMID: 21045096 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Joseph Quinn, MD
• Organization: Oregon Health and Sciences University/Portland VA Medical Center, Portland, Oregon.

quinnj@ohsu.edu

503-494-6976

Study Officials

• Joseph Quinn, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 25, 2014
• Results First Posted: August 30, 2010

Record last verified: 2014-09

Locations

US (51)