Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | N/A | Both | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
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.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 45.4874111, -122.6875541 | Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Oregon Health and Science University |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Lynne Shinto, MD, MPH | Principal Investigator | Oregon Health and Science University |
Study Contact:
| Name | Phone | |
|---|---|---|
Lauren McDonald | 503-494-7240 |
Locations
ClinicalTrials.gov ID
NCT01058941 (follow link to view full record on ct.gov in new window)
Official Title:
Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease
Study Start Date:
September 2010
Study End Date:
January 2015
Disease Stage:
Early
Middle
Enrollment:
100
