Trial Outcomes & Findings for DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease (NCT NCT00440050)
NCT ID: NCT00440050
Last Updated: 2014-09-25
Results Overview
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.
COMPLETED
PHASE3
402 participants
Baseline, 6, 12, 18 months
2014-09-25
Participant Flow
Subjects were recruited at 51 sites in the United States between February and November 2007.
Out of 555 subjects screened, 402 met the study criteria and were randomized.
Participant milestones
| Measure |
Placebo
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
238
|
|
Overall Study
COMPLETED
|
124
|
171
|
|
Overall Study
NOT COMPLETED
|
40
|
67
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=164 Participants
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 Participants
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
76 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
76 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
210 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=99 Participants
|
238 participants
n=107 Participants
|
402 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, 18 monthsADAS-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.
Outcome measures
| Measure |
Placebo
n=164 Participants
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 Participants
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
Rate of Change on the ADAS-Cog 11.
|
7.98 ADAS points per year
Standard Deviation 9.84
|
8.27 ADAS points per year
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: 18 monthsCDR-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.
Outcome measures
| Measure |
Placebo
n=164 Participants
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 Participants
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
Rate of Change on CDR-SOB
|
2.87 Units on a scale
Standard Deviation 2.93
|
2.93 Units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 18 monthsADCS-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.
Outcome measures
| Measure |
Placebo
n=164 Participants
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 Participants
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
ADCS-ADL
|
10.43 Units on a scale
Standard Deviation 11.74
|
11.51 Units on a scale
Standard Deviation 13.23
|
SECONDARY outcome
Timeframe: 18 monthsThe 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.
Outcome measures
| Measure |
Placebo
n=164 Participants
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 Participants
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
Neuropsychiatric Inventory (NPI)
|
2.93 Units on a scale
Standard Deviation 13.62
|
5.09 Units on a scale
Standard Deviation 15.08
|
Adverse Events
Placebo
Docosahexaenoic Acid (DHA)
Serious adverse events
| Measure |
Placebo
n=164 participants at risk
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 participants at risk
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
General disorders
death
|
2.4%
4/164 • Number of events 4
|
5.1%
11/214 • Number of events 11
|
|
Blood and lymphatic system disorders
deep venous thrombosis/pulmonary embolus
|
1.2%
2/164 • Number of events 2
|
3.7%
8/214 • Number of events 8
|
|
General disorders
other
|
26.8%
44/164 • Number of events 44
|
26.6%
57/214 • Number of events 57
|
Other adverse events
| Measure |
Placebo
n=164 participants at risk
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
|
Docosahexaenoic Acid (DHA)
n=238 participants at risk
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
6.1%
10/164 • Number of events 10
|
7.6%
18/238 • Number of events 18
|
|
Renal and urinary disorders
urinary tract infection
|
7.3%
12/164 • Number of events 12
|
9.7%
23/238 • Number of events 23
|
|
Injury, poisoning and procedural complications
fall
|
20.1%
33/164 • Number of events 33
|
17.6%
42/238 • Number of events 42
|
|
General disorders
dizziness
|
5.5%
9/164 • Number of events 9
|
5.0%
12/238 • Number of events 12
|
|
Psychiatric disorders
agitation
|
7.3%
12/164 • Number of events 12
|
10.1%
24/238 • Number of events 24
|
|
General disorders
other
|
53.7%
88/164 • Number of events 88
|
50.0%
119/238 • Number of events 119
|
Additional Information
Joseph Quinn, MD
Oregon Health and Sciences University/Portland VA Medical Center, Portland, Oregon.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place