Clinical trial NCT01780974: Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
Official title: Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Treated Hypertension
Keywords: Hypertension
Vascular Risk
Alzheimer's Risk
fish oil
Lipoic acid
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Trails Making Test Part B (Executive Function)
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: White Matter Hyperintensity Volume (Brain MRI)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Lynne Shinto, ND, MPH
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lynne Shinto, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References: