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| Sponsor: | Oregon Health and Science University |
|---|---|
| Information provided by (Responsible Party): | Lynne Shinto, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01058941 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: lipoic acid and fish oil concentrate |
Phase 1 Phase 2 |
| 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 |
| Official Title: | Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: lipoic acid and omega-3 fatty acids
lipoic acid and fish oil concentrate
|
Drug: lipoic acid and fish oil concentrate
lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
Other Names:
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Placebo Comparator: Placebo
placebo lipoic acid plus placebo oil
|
Drug: lipoic acid and fish oil concentrate
lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lauren McDonald, MS | 503-494-7240 | mcdonlau@ohsu.edu |
| Contact: Lynne Shinto, ND, MPH | 503-494-5035 | shintol@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: Lynne Shinto, ND, MPH | |
| Principal Investigator: | Lynne Shinto, ND, MPH | Oregon Health and Science University |
More Information
| Responsible Party: | Lynne Shinto, Lynne Shinto, ND, MPH, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01058941 History of Changes |
| Other Study ID Numbers: | R01AG033613-01A1 |
| Study First Received: | January 27, 2010 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's disease fish oil lipoic acid |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Thioctic Acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |