We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00440050
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : August 30, 2010
Last Update Posted : September 25, 2014
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

  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
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 
[Units: Years]
Mean (Standard Deviation)
 76  (9.3)   76  (7.8)   76  (8.7) 
[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 ]

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

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

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

  Serious Adverse Events

  Other Adverse Events

  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

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
e-mail: quinnj@ohsu.edu

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 )
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