Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description 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.

Serious Adverse Events
    Placebo     Docosahexaenoic Acid (DHA)  
Total, serious adverse events      
# participants affected / at risk     50/164 (30.49%)     76/238 (31.93%)  
Blood and lymphatic system disorders      
deep venous thrombosis/pulmonary embolus    
# participants affected / at risk     2/164 (1.22%)     8/214 (3.74%)  
# events     2     8  
General disorders      
death    
# participants affected / at risk     4/164 (2.44%)     11/214 (5.14%)  
# events     4     11  
other    
# participants affected / at risk     44/164 (26.83%)     57/214 (26.64%)  
# events     44     57  
Events were collected by systematic assessment




  Other Adverse Events
  Hide Other Adverse Events

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     214/238  
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
  Hide 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.


  More Information