Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
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ClinicalTrials.gov Identifier: NCT01780974 |
Recruitment Status :
Completed
First Posted : January 31, 2013
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Treated Hypertension | Drug: Lipoic Acid plus Omega-3 Fatty Acids Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo LA capsules per day. Capsules will be taken with food or a meal.
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Drug: Placebo
placebo capsules |
Experimental: Lipoic acid plus omega-3 fatty acids
Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg docosahexaenoic acid (DHA) and 975 mg eicosapentaenoic acid (EPA) plus 2 LA capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.
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Drug: Lipoic Acid plus Omega-3 Fatty Acids
alpha lipoic acid (racemic) and fish oil concentrate
Other Names:
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- Trails Making Test Part B (Executive Function) [ Time Frame: Baseline, 6 months, and 12 months ]The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
- White Matter Hyperintensity Volume (Brain MRI) [ Time Frame: Baseline and 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 55 years or older
- Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
- Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
- Stable dose of antihypertensive medication 4 month prior to study enrollment
- Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
- Low Omega-3 fatty acid Status: Omega-3 index, < 4% of total fatty acid of combined docosahexaenoic acid and eicosapentanoic acid
- Geriatric Depression Scale < 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:
- Alzheimer's, Dementia or other neurodegenerative disease.
- Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
- Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
- Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
- Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment
- Lipoic Acid supplementation less than 1 month prior to enrollment
- Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
- Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
- Enrollment in another treatment study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780974
United States, Oregon | |
Lynne Shinto, ND, MPH | |
Portland, Oregon, United States, 97239 | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Lynne Shinto, ND, MPH | Oregon Health and Science University |
Responsible Party: | Lynne Shinto, Associate Professor, Department of Neurology, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT01780974 |
Other Study ID Numbers: |
SFF01 |
First Posted: | January 31, 2013 Key Record Dates |
Results First Posted: | April 7, 2017 |
Last Update Posted: | April 7, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Hypertension Vascular Risk Alzheimer's Risk fish oil Lipoic acid |
Hypertension Vascular Diseases Cardiovascular Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action |
Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |