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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at 51 sites in the United States between February and November 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 555 subjects screened, 402 met the study criteria and were randomized.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Docosahexaenoic Acid (DHA)
STARTED   164   238 
COMPLETED   124   171 
NOT COMPLETED   40   67 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Docosahexaenoic Acid (DHA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 164   238   402 
Age 
[Units: Years]
Mean (Standard Deviation) 		 76  (9.3)   76  (7.8)   76  (8.7) 
Gender 
[Units: Participants]
 		     
Female   98   112   210 
Male   66   126   192 
Region of Enrollment 
[Units: Participants]
 		     
United States   164   238   402 


  Outcome Measures

1.  Primary:   Rate of Change on the ADAS-Cog 11.   [ Time Frame: Baseline, 6, 12, 18 months ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Rate of Change on the ADAS-Cog 11.
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Measured Values
   Placebo   Docosahexaenoic Acid (DHA) 
Participants Analyzed 
[Units: Participants]
 		 164   238 
Rate of Change on the ADAS-Cog 11. 
[Units: ADAS points per year]
Mean (Standard Deviation) 		 7.98  (9.84)   8.27  (8.9) 

No statistical analysis provided for Rate of Change on the ADAS-Cog 11.



2.  Primary:   Rate of Change on CDR-SOB   [ Time Frame: 18 months ]
  Show Outcome Measure 2

3.  Secondary:   ADCS-ADL   [ Time Frame: 18 months ]
  Show Outcome Measure 3

4.  Secondary:   Neuropsychiatric Inventory (NPI)   [ Time Frame: 18 months ]
  Show Outcome Measure 4


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
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.

Other Adverse Events
    Placebo   Docosahexaenoic Acid (DHA)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   144/164 (87.80%)   214/238 (89.92%) 
Gastrointestinal disorders     
diarrhea †     
# participants affected / at risk   10/164 (6.10%)   18/238 (7.56%) 
# events   10   18 
General disorders     
dizziness †     
# participants affected / at risk   9/164 (5.49%)   12/238 (5.04%) 
# events   9   12 
other †     
# participants affected / at risk   88/164 (53.66%)   119/238 (50.00%) 
# events   88   119 
Injury, poisoning and procedural complications     
fall †     
# participants affected / at risk   33/164 (20.12%)   42/238 (17.65%) 
# events   33   42 
Psychiatric disorders     
agitation †     
# participants affected / at risk   12/164 (7.32%)   24/238 (10.08%) 
# events   12   24 
Renal and urinary disorders     
urinary tract infection †     
# participants affected / at risk   12/164 (7.32%)   23/238 (9.66%) 
# events   12   23 
† Events were collected by systematic assessment



  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information