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Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01058941
First received: January 27, 2010
Last updated: March 1, 2017
Last verified: March 2017
Results First Received: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Lipoic acid and fish oil concentrate
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lipoic Acid and Omega-3 Fatty Acids

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Placebo

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months


Participant Flow:   Overall Study
    Lipoic Acid and Omega-3 Fatty Acids   Placebo
STARTED   34   33 
COMPLETED   25   22 
NOT COMPLETED   9   11 



  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
Lipoic Acid and Omega-3 Fatty Acids

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Placebo

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Total Total of all reporting groups

Baseline Measures
   Lipoic Acid and Omega-3 Fatty Acids   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  14.7%      4  12.1%      9  13.4% 
>=65 years      29  85.3%      29  87.9%      58  86.6% 
Age 
[Units: Years]
Mean (Full Range)
 73.3 
 (56 to 92) 
 76.2 
 (52 to 89) 
 74.7 
 (52 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  52.9%      17  51.5%      35  52.2% 
Male      16  47.1%      16  48.5%      32  47.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      34 100.0%      32  97.0%      66  98.5% 
Unknown or Not Reported      0   0.0%      1   3.0%      1   1.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   3.0%      1   1.5% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   2.9%      1   3.0%      2   3.0% 
White      33  97.1%      30  90.9%      63  94.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   3.0%      1   1.5% 
Region of Enrollment 
[Units: Participants]
     
United States   34   33   67 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Activities of Daily Living (ADL) at 18 Months   [ Time Frame: Baseline and 18 months ]

2.  Primary:   Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months   [ Time Frame: Baseline and 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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  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: Dr. Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
phone: 503-494-5035
e-mail: shintol@ohsu.edu



Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01058941     History of Changes
Other Study ID Numbers: R01AG033613-01A1 ( U.S. NIH Grant/Contract )
Study First Received: January 27, 2010
Results First Received: March 1, 2017
Last Updated: March 1, 2017