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
docsahexanoic 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