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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
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 
Overall Participants Analyzed 
[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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Placebo   Docosahexaenoic Acid (DHA)
Total, other (not including serious) adverse events     
# participants affected / at risk   144/164 (87.80%)   214/238 (89.92%) 
Gastrointestinal disorders     
diarrhea †     
# participants affected / at risk   10/164 (6.10%)   18/238 (7.56%) 
# events   10   18 
General disorders     
dizziness †     
# participants affected / at risk   9/164 (5.49%)   12/238 (5.04%) 
# events   9   12 
other †     
# participants affected / at risk   88/164 (53.66%)   119/238 (50.00%) 
# events   88   119 
Injury, poisoning and procedural complications     
fall †     
# participants affected / at risk   33/164 (20.12%)   42/238 (17.65%) 
# events   33   42 
Psychiatric disorders     
agitation †     
# participants affected / at risk   12/164 (7.32%)   24/238 (10.08%) 
# events   12   24 
Renal and urinary disorders     
urinary tract infection †     
# participants affected / at risk   12/164 (7.32%)   23/238 (9.66%) 
# events   12   23 
Events were collected by systematic assessment



  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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00440050     History of Changes
Other Study ID Numbers: IA0099
1RC2AG036535 ( US NIH Grant/Contract Award Number )
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