Alzheimer's Disease Education and Referral Center

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

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

Overall Status: 
Active, not recruiting
Brief Description: 

The purpose of this study is to see if taking lipoic acid plus omega-3 fatty acids can slow the Alzheimer's disease process. The investigators will look at changes in participants' memory and daily activities over 18 months.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
N/A
Both
No
Inclusion Criteria: 
    • Probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria)
    • Mini-Mental State Examination score of 15-26
    • Caregiver/study partner who can accompany participant to all study visits
    • Stable use of cholinesterase inhibitors and/or memantine is permitted; doses must be stable for 4 months prior to study enrollment
    • Stable dose of over-the-counter antioxidants (such as vitamin E or ginkgo biloba) is permitted; dose must be stable for 4 months prior to study enrollment
    • Stable dose of lipid-lowering medication is permitted; dose must be stable for 4 months prior to study enrollment
    • Geriatric Depression Scale score of less than 5
    • General health status that will not interfere with the participant's ability to complete the study
    • Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
    • Sufficient English language skills to complete all testing
Exclusion Criteria: 
    • Non-Alzheimer's dementia
    • Residence in a nursing home (residence in assisted living or other long-term care facility in which the participant still performs most basic activities of daily living is allowed)
    • 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 under 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 or seizure disorder
    • Insulin-dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin is acceptable)
    • Hyperlipidemic (triglycerides level of more than 500 mg/dl, LDL more than 160 mg/dl, total cholesterol more than 240 mg/dl); LDL levels of 160-165 mg/dl will be reviewed and included if judged to be safe
    • Fish intake of one 6-ounce serving more than once a week; omega-3 fatty acid supplement intake (fish oil capsules, cod liver oil, or flaxseed oil)
    • Lipoic acid supplementation less than 1 month prior to enrollment
    • Other prohibited medications: corticosteroids, neuroleptics, antiparkinsonian agents, and narcotic analgesics (certain low-dose antipsychotics may be allowed)
    • Contraindications to magnetic resonance imaging
    • Enrollment in another study
Detailed Description: 

Current pharmacological agents for Alzheimer's disease have limited effects on the clinical course of the disease. The rise in the prevalence, incidence, and cost of care for Alzheimer's make finding therapeutic agents that can either prevent or delay the disease an urgent health care need. Since inflammation, lipid dysregulation, and insulin resistance have each been associated with Alzheimer's 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.

The primary aim of this Phase I/II study is to evaluate the ability of lipoic acid plus omega-3 fatty acids to delay cognitive and functional decline in people with Alzheimer's disease. The investigators will also evaluate the effect of these supplements on changes in serum and plasma biomarkers over 18 months to determine which markers are associated with whole brain atrophy and clinical outcomes.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 45.4874111, -122.6875541

Site
Portland
Oregon
97239
Name:
Phone:
Lead Sponsor: 
Agency
Oregon Health and Science University
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Lynne Shinto
Principal Investigator
Oregon Health and Science University
Study Contact: 
NamePhoneEmail
Lauren McDonald
503-494-7240
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease
Study Start Date: 
September 2010
Study End Date: 
January 2015
Enrollment: 
100