Alzheimer's Disease Clinical Trial
Official title:
Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease
The purpose of this study is 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 will look at changes in memory and changes in a person's daily activities over 18 months.
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. Our primary study aim is to evaluate the ability of lipoic acid plus omega-3 fatty acids to delay cognitive and functional decline in people with AD. The investigators will also evaluate the effect of lipoic acid plus omega-3 fatty acids on changes in serum and plasma biomarkers over 18 months to determine which markers are associated with whole brain atrophy (MRI volume changes) and clinical outcomes (ADAS-cog, ADL). The associations identified will aid in the identification of specific biomarkers that may be used to evaluate treatment effects in future clinical trials. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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