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

  • Completed

This study will evaluate whether taking lipoic acid and omega-3 fatty acids can slow the process of Alzheimer's disease in people with mild to moderate Alzheimer's. Investigators will look at changes in participants' memory and daily activities for 18 months.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A Both No
September 2010
January 2015
100
  • Probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria
  • Mini Mental Status Examination score of 15-26
  • Caregiver/study partner who can accompany participant to all study visits
  • Cholinesterase inhibitors, memantine, over-the-counter antioxidants (for example, vitamin E, ginkgo biloba), and lipid-lowering medication permitted; must be on stable dose for 4 months prior to study enrollment
  • Geriatric Depression Scale score of less than 5
  • Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
  • Sufficient English language skills to complete all testing
  • Non-Alzheimer's dementia
  • Living in a nursing home; living in assisted living or other long-term care facility in which the participant still performs most basic activities of daily living is permitted
  • History of clinically significant stroke (stroke with neurologic deficits more than 6 months after diagnosis)
  • Health conditions such as cancer diagnosed fewer than 5 years prior to enrollment (prostate cancer gleason grade of les than 3 and nonmetastatic skin cancers are acceptable)
  • Liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases such as brain tumor, seizure disorder
  • Insulin-dependent or uncontrolled diabetes; diabetes controlled by medications other than insulin is acceptable
  • Hyperlipidemic (triglycerides >500 mg/dl, low-density lipoprotein >160 mg/dl, total cholesterol >240 mg/dl)
  • Fish intake of one 6-ounce serving more than once a week less than 4 months prior to enrollment
  • Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 4 months prior to enrollment
  • Lipoic acid supplementation less than 1 month prior to enrollment
  • Prohibited medications: systemic corticosteroids, neuroleptics, antiparkinsonian agents, narcotic analgesics; low-dose antipsychotic use will be reviewed on a case-by-case basis and may be allowed
  • Contraindications to MRI
  • Enrollment in another study

Current medications for Alzheimer's disease have had no impact on disease prevalence and limited effects on improving the clinical course of people with Alzheimer's. In this study, researchers will determine if taking lipoic acid (600 mg/day) plus omega-3 fatty acids (3 grams/day) can delay cognitive and functional decline in people with mild to moderate Alzheimer's disease, compared with a placebo. Both supplements are taken by mouth.

This combination of supplements has the potential to act on inflammation, lipid dysregulation, and insulin resistance, each of which has been associated with Alzheimer's pathology. Investigators will also evaluate the effect of lipoic acid and omega-3 fatty acids on changes in serum and plasma biomarkers over 18 months to determine which markers are associated with whole brain atrophy and clinical outcomes.

Name City State Zip Status Primary Contact
Oregon Health & Science University Portland Oregon 97239

Oregon Health and Science University

Name Role Affiliation
Lynne Shinto, MD, MPH Principal Investigator Oregon Health and Science University

Name Phone Extension Email
Lauren McDonald 503-494-7240 mcdonlau@ohsu.edu

Lipoic Acid and Omega-3 Fatty Acids in Alzheimer`s Disease