Alzheimer's DiseasePhase 3DHANCT00440050
DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease
A Phase 3 study testing DHA (Docosahexaenoic Acid) in people with Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 51 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- DHA (Docosahexaenoic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 51 sitesUnited States
- Study dates
- Feb 2007to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Albany Medical College
Albany, New York, 12208
Dent Neurological Institute
Amherst, New York, 14226
University of Michigan Dept. of Neurology
Ann Arbor, Michigan, 48105
Emory University Dept. of Psychiatry
Atlanta, Georgia, 30322
Johns Hopkins University Division of Cognitive Neuroscience
Baltimore, Maryland, 20205
The Memory Clinic
Bennington, Vermont, 05201
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University Alzheimer's Disease Clinical and Research Program
Boston, Massachusetts, 02118
Northwestern University Cognitive Neurology and Alzheimer Disease Center
Chicago, Illinois, 60611
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612
Case Western Reserve University Memory and Aging Center
Cleveland, Ohio, 44120
The Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern-Memory Research Unit
Dallas, Texas, 75390
Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Baylor University Department of Neurology
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of California Irvine
Irvine, California, 92697
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
UCSD Shiley-Marcos Alzheimer's Research Center
La Jolla, California, 92037
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky, Lexington, Sanders-Brown Center on Aging/Neurology
Lexington, Kentucky, 40536
University of Southern California Psychiatry and Behavioral Sciences
Los Angeles, California, 90033
UCLA Neurology
Los Angeles, California, 90095
University of Wisconsin Department of Medicine
Madison, Wisconsin, 53705
Wien Center
Miami Beach, Florida, 33140
Meharry Medical College
Nashville, Tennessee, 37208
Yale University School of Medicine
New Haven, Connecticut, 06510
New York University Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Medical University of South Carolina
North Charleston, South Carolina, 29406
Palo Alto Institute for Research & Education
Palo Alto, California, 94304
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University Neurology
Portland, Oregon, 97239
Rhode Island Hospital Neurology
Providence, Rhode Island, 02903
Mayo Clinic Rochester, Alzheimer's Disease Research Center
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14620
UC-Davis Alzheimer's Disease Center
Sacramento, California, 95817
Pacific Research Network
San Diego, California, 92103
University of Washington/Seattle Institute for Biomedical & Clinical Research
Seattle, Washington, 98108
Saint Louis University, Department of Psychiatry
St Louis, Missouri, 63104
Washington University ADRC-Memory and Aging Project
St Louis, Missouri, 63108
Sun Health Research Institute/Arizona Consortium
Sun City, Arizona, 85351
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, 33617
Byrd Alzheimer's Institute
Tampa, Florida, 33647
Mount Sinai School of Medicine
The Bronx, New York, 10468
Georgetown University Medical Center, Dept. of Neurology
Washington D.C., District of Columbia, 20057
Howard University College of Medicine
Washington D.C., District of Columbia, 20060
Wake Forest University Health Services
Winston-Salem, North Carolina, 27157
About this 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
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).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- DHA (Docosahexaenoic Acid), Placebo
- Keywords
- fish oil, omega-3 fatty acids, EPA
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA (Docosahexaenoic Acid)Drug
Also called Neuromins
950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
PlaceboDrug
2 placebo capsules twice a day for 18 months
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | DHA Receives: Drug: DHA (Docosahexaenoic Acid) |
| 2. | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (2)
ADCS-ADL
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.
Measured: 18 months
Neuropsychiatric Inventory (NPI)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Joseph Quinn, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440050
- Sponsor's protocol ID
- IA0099
- Other IDs
- 1RC2AG036535, ADC-027-DHA
- Acronym
- DHA
- Status last verified
- Sep 2014
- First submitted
- 22 Feb 2007
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 15041028Kalmijn 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.
PubMed 14745067Morris 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.
PubMed 12873849Suzuki 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.
PubMed 11935973Calon 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.
PubMed 15339646Lim 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.
PubMed 15788759Jimenez-Maggiora GA, Donohue MC, Rafii MS, Raman R, Aisen PS. Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials. J Prev Alzheimers Dis. 2025 Jan;12(1):100002. doi: 10.1016/j.tjpad.2024.100002. Epub 2025 Jan 1.
PubMed 39800465Yassine 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.
PubMed 27358067Quinn 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.
PubMed 21045096
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Trial Of The Effects Of Docosahexaenoic Acid (DHA) In Slowing The Progression Of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00440050
- Acronym / sponsor ID
- DHA / IA0099
- Conditions
- Alzheimer's Disease
- Keywords
- fish oil, omega-3 fatty acids, EPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)University, hospital or other
- Collaborators
- National Institute on Aging (NIA), dsm-firmenich Switzerland AG
- Study start
- Feb 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Posted 30 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Drug: DHA (Docosahexaenoic Acid)DHA |
| 2. | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA (Docosahexaenoic Acid)Also: Neuromins950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months | Drug | 1. |
| Placebo2 placebo capsules twice a day for 18 months | Drug | 2. |
Primary outcome
Rate of Change on the ADAS-Cog 11.
Time frame: Baseline, 6, 12, 18 months
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
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.
2 secondary outcomes
ADCS-ADL
Time frame: 18 months
Neuropsychiatric Inventory (NPI)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15041028Horrocks 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.
- Background: PubMed 14745067Kalmijn 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.
- Background: PubMed 12873849Morris 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.
- Background: PubMed 11935973Suzuki 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.
- Background: PubMed 15339646Calon 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.
- Background: PubMed 15788759Lim 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.
- Derived from this study: PubMed 39800465Jimenez-Maggiora GA, Donohue MC, Rafii MS, Raman R, Aisen PS. Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials. J Prev Alzheimers Dis. 2025 Jan;12(1):100002. doi: 10.1016/j.tjpad.2024.100002. Epub 2025 Jan 1.
- Derived from this study: PubMed 27358067Yassine 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.
- Derived from this study: PubMed 21045096Quinn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Quinn, MD principal investigator
Oregon Health and Science University
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DHA (Docosahexaenoic Acid) in people with Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change on the ADAS-Cog 11. (time frame: Baseline, 6, 12, 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440050, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.