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DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease (DHA)

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ClinicalTrials.gov Identifier: NCT00440050
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : August 30, 2010
Last Update Posted : September 25, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: DHA (Docosahexaenoic Acid)
Drug: Placebo
Enrollment 402

Recruitment Details Subjects were recruited at 51 sites in the United States between February and November 2007.
Pre-assignment Details Out of 555 subjects screened, 402 met the study criteria and were randomized.
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description Dosing of 2 grams of placebo administered in a divided dose twice daily with food. Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Period Title: Overall Study
Started 164 238
Completed 124 171
Not Completed 40 67
Arm/Group Title Placebo Docosahexaenoic Acid (DHA) Total
Hide Arm/Group Description Dosing of 2 grams of placebo administered in a divided dose twice daily with food. Dosing of 2 grams of DHA administered in a divided dose twice daily with food. Total of all reporting groups
Overall Number of Baseline Participants 164 238 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 238 participants 402 participants
76  (9.3) 76  (7.8) 76  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 238 participants 402 participants
Female
98
  59.8%
112
  47.1%
210
  52.2%
Male
66
  40.2%
126
  52.9%
192
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 164 participants 238 participants 402 participants
164 238 402
1.Primary Outcome
Title Rate of Change on the ADAS-Cog 11.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description:
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Overall Number of Participants Analyzed 164 238
Mean (Standard Deviation)
Unit of Measure: ADAS points per year
7.98  (9.84) 8.27  (8.9)
2.Primary Outcome
Title Rate of Change on CDR-SOB
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description:
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Overall Number of Participants Analyzed 164 238
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.87  (2.93) 2.93  (2.83)
3.Secondary Outcome
Title ADCS-ADL
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description:
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Overall Number of Participants Analyzed 164 238
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.43  (11.74) 11.51  (13.23)
4.Secondary Outcome
Title Neuropsychiatric Inventory (NPI)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description:
Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Overall Number of Participants Analyzed 164 238
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.93  (13.62) 5.09  (15.08)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Docosahexaenoic Acid (DHA)
Hide Arm/Group Description Dosing of 2 grams of placebo administered in a divided dose twice daily with food. Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
All-Cause Mortality
Placebo Docosahexaenoic Acid (DHA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Docosahexaenoic Acid (DHA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/164 (30.49%)      76/238 (31.93%)    
Blood and lymphatic system disorders     
deep venous thrombosis/pulmonary embolus   2/164 (1.22%)  2 8/214 (3.74%)  8
General disorders     
death   4/164 (2.44%)  4 11/214 (5.14%)  11
other   44/164 (26.83%)  44 57/214 (26.64%)  57
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Docosahexaenoic Acid (DHA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   144/164 (87.80%)      214/238 (89.92%)    
Gastrointestinal disorders     
diarrhea   10/164 (6.10%)  10 18/238 (7.56%)  18
General disorders     
dizziness   9/164 (5.49%)  9 12/238 (5.04%)  12
other   88/164 (53.66%)  88 119/238 (50.00%)  119
Injury, poisoning and procedural complications     
fall   33/164 (20.12%)  33 42/238 (17.65%)  42
Psychiatric disorders     
agitation   12/164 (7.32%)  12 24/238 (10.08%)  24
Renal and urinary disorders     
urinary tract infection   12/164 (7.32%)  12 23/238 (9.66%)  23
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Joseph Quinn, MD
Organization: Oregon Health and Sciences University/Portland VA Medical Center, Portland, Oregon.
Phone: 503-494-6976
Publications:
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 ( U.S. NIH Grant/Contract )
ADC-027-DHA
First Submitted: February 22, 2007
First Posted: February 26, 2007
Results First Submitted: May 28, 2010
Results First Posted: August 30, 2010
Last Update Posted: September 25, 2014