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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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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
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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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Measure Type Secondary
Measure Title Neuropsychiatric Inventory (NPI)
Measure 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  
Safety Issue No  

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.

Measured Values
    Placebo     Docosahexaenoic Acid (DHA)  
Number of Participants Analyzed  
[units: participants]
 		  164     238  
Neuropsychiatric Inventory (NPI)  
[units: Units on a scale]
Mean ± Standard Deviation 		  2.93  ± 13.62     5.09  ± 15.08  

No statistical analysis provided for Neuropsychiatric Inventory (NPI)




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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