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
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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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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  
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 ]
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Measure Type Secondary
Measure Title ADCS-ADL
Measure Description ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower 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.
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)  
Number of Participants Analyzed  
[units: participants]
  164     238  
ADCS-ADL  
[units: Units on a scale]
Mean ± Standard Deviation
  10.43  ± 11.74     11.51  ± 13.23  

No statistical analysis provided for ADCS-ADL



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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