Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01058941 |
Recruitment Status
:
Completed
First Posted
: January 29, 2010
Results First Posted
: April 13, 2017
Last Update Posted
: April 13, 2017
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Sponsor:
Oregon Health and Science University
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
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Tracking Information | ||||
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First Submitted Date ICMJE | January 27, 2010 | |||
First Posted Date ICMJE | January 29, 2010 | |||
Results First Submitted Date | March 1, 2017 | |||
Results First Posted Date | April 13, 2017 | |||
Last Update Posted Date | April 13, 2017 | |||
Study Start Date ICMJE | September 2010 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Activities of Daily Living and Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: baseline, 6 months, 12 months, 18 months ] | |||
Change History | Complete list of historical versions of study NCT01058941 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease | |||
Official Title ICMJE | Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease | |||
Brief Summary | The purpose of this study was to see if taking lipoic acid plus omega-3 fatty acids (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow the AD process, the investigators looked at changes in memory and changes in a person's daily activities over 18 months. | |||
Detailed Description | Current pharmacological agents for AD have had no impact on disease prevalence and have had limited effects on improving the clinical course of AD. The exponential rise in the prevalence, incidence, and cost of care for AD make finding therapeutic agents that can either prevent AD or delay disease progression an urgent health care need. Since inflammation, lipid dysregulation, and insulin resistance have each been associated with AD pathology, the combination of lipoic acid plus fish oil has the potential to maximize therapeutic benefit by acting on all three mechanisms associated with disease pathology. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
67 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 55 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01058941 | |||
Other Study ID Numbers ICMJE | R01AG033613-01A1( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Lynne Shinto, Oregon Health and Science University | |||
Study Sponsor ICMJE | Oregon Health and Science University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |