A Phase 3 interventional study of DHA (Docosahexaenoic Acid) and Placebo in Alzheimer's Disease, sponsored by Alzheimer's Disease Cooperative Study (ADCS). Completed at 51 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by Alzheimer's Disease Cooperative Study (ADCS) · Phase 3, Interventional, and Treatment
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).
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 402 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Alzheimer's Disease Cooperative Study (ADCS) is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
DHA
Drug: DHA (Docosahexaenoic Acid)
Placebo
Drug: Placebo
950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
Also known as: Neuromins
2 placebo capsules twice a day for 18 months
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.
Time frame: 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.
Time frame: 18 months
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.
Time frame: 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.
Time frame: 18 months
Subjects were recruited at 51 sites in the United States between February and November 2007.
| Milestone | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| Started | 164 | 238 |
| Completed | 124 | 171 |
| Not completed | 40 | 67 |
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.
| ADAS points per year | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| Rate of Change on the ADAS-Cog 11. | 7.98 ± 9.84 | 8.27 ± 8.9 |
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.
| Units on a scale | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| Rate of Change on CDR-SOB | 2.87 ± 2.93 | 2.93 ± 2.83 |
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.
| Units on a scale | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| ADCS-ADL | 10.43 ± 11.74 | 11.51 ± 13.23 |
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.
| Units on a scale | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| Neuropsychiatric Inventory (NPI) | 2.93 ± 13.62 | 5.09 ± 15.08 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 50/164 (30.5%) | 144/164 (87.8%) |
| Docosahexaenoic Acid (DHA) | — | 76/238 (31.9%) | 214/238 (89.9%) |
| Event | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| otherGeneral disorders | 44/164 | 57/214 |
| deathGeneral disorders | 4/164 | 11/214 |
| deep venous thrombosis/pulmonary embolusBlood and lymphatic system disorders | 2/164 | 8/214 |
| Event | Placebo | Docosahexaenoic Acid (DHA) |
|---|---|---|
| otherGeneral disorders | 88/164 | 119/238 |
| fallInjury, poisoning and procedural complications | 33/164 | 42/238 |
| agitationPsychiatric disorders | 12/164 | 24/238 |
| urinary tract infectionRenal and urinary disorders | 12/164 | 23/238 |
| diarrheaGastrointestinal disorders | 10/164 | 18/238 |
| dizzinessGeneral disorders | 9/164 | 12/238 |
| Age, Continuous(years) | Placebo | Docosahexaenoic Acid (DHA) | Total |
|---|---|---|---|
| Mean | 76 ± 9.3 | 76 ± 7.8 | 76 ± 8.7 |
| Sex: Female, Male(Participants) | Placebo | Docosahexaenoic Acid (DHA) | Total |
|---|---|---|---|
| Female | 98 | 112 | 210 |
| Male | 66 | 126 | 192 |
| Region of Enrollment(participants) | Placebo | Docosahexaenoic Acid (DHA) | Total |
|---|---|---|---|
| United States | 164 | 238 | 402 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Alzheimer's Disease Cooperative Study (ADCS)