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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT00440050

Run by

Alzheimer's Disease Cooperative Study (ADCS)

People needed

402

Starts

2007-02-01

Expected to finish

2009-05-01

Last updated by the study team

2014-09-25

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• 50 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)

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Sun Health Research Institute/Arizona Consortium — Sun City, Arizona, United States
• University of California Irvine — Irvine, California, United States
• UCSD Shiley-Marcos Alzheimer's Research Center — La Jolla, California, United States
• University of Southern California Psychiatry and Behavioral Sciences — Los Angeles, California, United States
• UCLA Neurology — Los Angeles, California, United States
• Palo Alto Institute for Research & Education — Palo Alto, California, United States
• UC-Davis Alzheimer's Disease Center — Sacramento, California, United States
• Pacific Research Network — San Diego, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center, Dept. of Neurology — Washington D.C., District of Columbia, United States
• Howard University College of Medicine — Washington D.C., District of Columbia, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Wien Center — Miami Beach, Florida, United States
• University of South Florida Suncoast Alzheimer's and Gerontology Center — Tampa, Florida, United States
• Byrd Alzheimer's Institute — Tampa, Florida, United States
• Emory University Dept. of Psychiatry — Atlanta, Georgia, United States
• Northwestern University Cognitive Neurology and Alzheimer Disease Center — Chicago, Illinois, United States
• Rush Alzheimer's Disease Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky, Lexington, Sanders-Brown Center on Aging/Neurology — Lexington, Kentucky, United States
• Johns Hopkins University Division of Cognitive Neuroscience — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Alabama, Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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