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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Martek Biosciences Corporation
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT00440050
First received: February 22, 2007
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
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
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  Baseline Characteristics
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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 ]
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2.  Primary:   Rate of Change on CDR-SOB   [ Time Frame: 18 months ]
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3.  Secondary:   ADCS-ADL   [ Time Frame: 18 months ]
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4.  Secondary:   Neuropsychiatric Inventory (NPI)   [ Time Frame: 18 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: January 10, 2013
Health Authority: United States: Food and Drug Administration