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

This study has been completed.
Sponsor:
Collaborators:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT00440050
First received: February 22, 2007
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: May 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: DHA (Docosahexaenoic Acid)
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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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.
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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  
Number of Participants  
[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
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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
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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
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  More Information
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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:
Publications automatically indexed to this study:

Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00440050     History of Changes
Other Study ID Numbers: IA0099, 1RC2AG036535, ADC-027-DHA
Study First Received: February 22, 2007
Results First Received: May 28, 2010
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration