Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention

The primary aim is to collect data so that we can determine effect size between lipoic acid plus omega-3 fatty acids and placebo on the primary outcome measure Trails B (executive function). This is designed as a pilot randomized, double-blind, placebo-controlled study with a 12 month intervention period. Thirty participants diagnosed with hypertension that is treated (systolic blood pressure 90-160 mm Hg, diastolic blood pressure 60-90 mm Hg) that have low omega-3 fatty acid levels, and normal cognitive function will be randomized to receive study drug or placebo.

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