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

This study has been completed.
Sponsor:
Collaborators:
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: May 15, 2013
Last verified: May 2013
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.
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 ]

Measure Type Primary
Measure Title Rate of Change on the ADAS-Cog 11.
Measure Description ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.
Time Frame Baseline, 6, 12, 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  
Rate of Change on the ADAS-Cog 11.  
[units: ADAS points per year]
Mean ± Standard Deviation
  7.98  ± 9.84     8.27  ± 8.9  

No statistical analysis provided for Rate of Change on the ADAS-Cog 11.



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

Measure Type Primary
Measure Title Rate of Change on CDR-SOB
Measure Description CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 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.
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  
Rate of Change on CDR-SOB  
[units: Units on a scale]
Mean ± Standard Deviation
  2.87  ± 2.93     2.93  ± 2.83  

No statistical analysis provided for Rate of Change on CDR-SOB



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

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 ]

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.
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  
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


  Other Adverse Events


  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
No text entered.  


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: May 15, 2013
Health Authority: United States: Food and Drug Administration