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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborators: |
Alzheimer's Disease Cooperative Study (ADCS) Martek Biosciences Corporation |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00440050 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: DHA (Docosahexaenoic Acid) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Double-Blind Placebo-Controlled Trial Of The Effects Of Docosahexaenoic Acid (DHA) In Slowing The Progression Of Alzheimer's Disease |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1.: Experimental
DHA
|
Drug: DHA (Docosahexaenoic Acid)
950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
|
|
2.: Placebo Comparator
Placebo
|
Drug: Placebo
2 placebo capsules twice a day for 18 months
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Palo Alto Institute for Research & Education | |
| Palo Alto, California, United States, 94304 | |
| University of California Irvine | |
| Irvine, California, United States, 92697 | |
| Pacific Research Network | |
| San Diego, California, United States, 92103 | |
| UC-Davis Alzheimer's Disease Center | |
| Sacramento, California, United States, 95817 | |
| UCLA Neurology | |
| Los Angeles, California, United States, 90095 | |
| UCSD Shiley-Marcos Alzheimer's Research Center | |
| La Jolla, California, United States, 92037 | |
| University of Southern California Psychiatry and Behavioral Sciences | |
| Los Angeles, California, United States, 90033 | |
| 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 | |
| Byrd Alzheimer's Institute | |
| Tampa, Florida, United States, 33647 | |
| Mayo Clinic, Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of South Florida Suncoast Alzheimer's and Gerontology Center | |
| Tampa, Florida, United States, 33617 | |
| Wien Center | |
| Miami Beach, Florida, United States, 33140 | |
| 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 | |
| Saint Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Dept. of Neurology | |
| Ann Arbor, Michigan, United States, 48105 | |
| 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 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| Dent Neurological Institute | |
| Amherst, New York, United States, 14226 | |
| Mount Sinai School of Medicine | |
| Bronx, New York, United States, 10468 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| 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 | |
| Baylor University Department of Neurology | |
| Houston, Texas, United States, 77030 | |
| University of Texas Southwestern-Memory Research Unit | |
| Dallas, Texas, United States, 75390 | |
| 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 | |
| Principal Investigator: | Joseph Quinn, MD | Oregon Health and Science University |
More Information
| Responsible Party: | Alzheimer's Disease Cooperative Study ( Paul Aisen, MD ) |
| Study ID Numbers: | IA0099, ADC-027-DHA |
| Study First Received: | February 22, 2007 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00440050 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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fish oil omega-3 fatty acids EPA |
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Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |