Trial record 1 of 1 for:    NCT00440050
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DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborators:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT00440050
First received: February 22, 2007
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Drug: DHA (Docosahexaenoic Acid)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Trial Of The Effects Of Docosahexaenoic Acid (DHA) In Slowing The Progression Of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Alzheimer's Disease Cooperative Study (ADCS):

Primary Outcome Measures:
  • Rate of Change on the ADAS-Cog 11. [ Time Frame: Baseline, 6, 12, 18 months ] [ Designated as safety issue: No ]
    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.

  • Rate of Change on CDR-SOB [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • ADCS-ADL [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.

  • Neuropsychiatric Inventory (NPI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.


Enrollment: 402
Study Start Date: February 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.
DHA
Drug: DHA (Docosahexaenoic Acid)
950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
Other Name: Neuromins
Placebo Comparator: 2.
Placebo
Drug: Placebo
2 placebo capsules twice a day for 18 months

Detailed Description:

Preliminary studies have shown a reduced risk of Alzheimer's disease (AD) in people consuming increased amounts of fish in their diets. Many of the health benefits of fish are attributed to the abundance of omega 3 fatty acids. Docosahexaenoic Acid (DHA) is the most abundant omega 3 fatty acid in the brain. Data from several animal models supports the hypothesis that DHA may be an effective treatment for AD by means of anti-amyloid, antioxidant, and neuroprotectant mechanisms.

In this study, 400 individuals with mild to moderate AD will participate at approximately 53 study sites throughout the US for 18 months. Participants will be randomized so that 60% will receive approximately 2 grams of DHA, divided into 4 capsules, 2 capsules taken twice a day, while 40% receive an identical placebo.

Potential participants will go to their study site for a screening visit, where eligibility is determined, and if accepted, for a baseline visit where cognitive status, behavioral status, functional status, and global severity of dementia will be assessed. Vital signs and biomarker labs will also be obtained. Subsequent visits will occur every three months for medication checks and, every 6 months, further assessments, physical exams, and labs.

Some participants will also take part in MRI (magnetic resonance imaging) and/or CSF (cerebrospinal fluid) sub-studies. For the MRI sub-study, scans will be done prior to beginning the study medication, and again after 18 months. Likewise, for the CSF sub-study, a lumbar puncture will be done prior to beginning the study medication, and again after 18 months.

Enrollment is restricted to individuals who consume no more than 200 mg of DHA per day, which is almost 300% of the average daily intake in an American diet. Individuals who take fish oil or omega 3 fatty acid supplements are also not eligible. Each visit will include completion of a very brief food frequency questionnaire to monitor dietary DHA levels.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440050

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institute/Arizona Consortium
Sun City, Arizona, United States, 85351
United States, California
University of California Irvine
Irvine, California, United States, 92697
UCSD Shiley-Marcos Alzheimer's Research Center
La Jolla, California, United States, 92037
UCLA Neurology
Los Angeles, California, United States, 90095
University of Southern California Psychiatry and Behavioral Sciences
Los Angeles, California, United States, 90033
Palo Alto Institute for Research & Education
Palo Alto, California, United States, 94304
UC-Davis Alzheimer's Disease Center
Sacramento, California, United States, 95817
Pacific Research Network
San Diego, California, United States, 92103
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center, Dept. of Neurology
Washington, District of Columbia, United States, 20057
Howard University College of Medicine
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
Wien Center
Miami Beach, Florida, United States, 33140
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States, 33617
Byrd Alzheimer's Institute
Tampa, Florida, United States, 33647
United States, Georgia
Emory University Dept. of Psychiatry
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Cognitive Neurology and Alzheimer Disease Center
Chicago, Illinois, United States, 60611
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky, Lexington, Sanders-Brown Center on Aging/Neurology
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins University Division of Cognitive Neuroscience
Baltimore, Maryland, United States, 20205
United States, Massachusetts
Boston University Alzheimer's Disease Clinical and Research Program
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Dept. of Neurology
Ann Arbor, Michigan, United States, 48105
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic Rochester, Alzheimer's Disease Research Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis University, Department of Psychiatry
St. Louis, Missouri, United States, 63104
Washington University ADRC-Memory and Aging Project
St. Louis, Missouri, United States, 63108
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Dent Neurological Institute
Amherst, New York, United States, 14226
Mount Sinai School of Medicine
Bronx, New York, United States, 10468
Columbia University
New York, New York, United States, 10032
New York University Medical Center
New York, New York, United States, 10016
University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, North Carolina
Wake Forest University Health Services
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University Memory and Aging Center
Cleveland, Ohio, United States, 44120
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University Neurology
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Neurology
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
United States, Texas
University of Texas Southwestern-Memory Research Unit
Dallas, Texas, United States, 75390
Baylor University Department of Neurology
Houston, Texas, United States, 77030
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Washington
University of Washington/Seattle Institute for Biomedical & Clinical Research
Seattle, Washington, United States, 98108
United States, Wisconsin
University of Wisconsin Department of Medicine
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Joseph Quinn, MD Oregon Health and Science University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00440050     History of Changes
Other Study ID Numbers: IA0099, 1RC2AG036535, ADC-027-DHA
Study First Received: February 22, 2007
Results First Received: May 28, 2010
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alzheimer's Disease Cooperative Study (ADCS):
fish oil
omega-3 fatty acids
EPA

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014