NCT01780974

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treated Hypertension

Interventions

Type	Name	Description
DRUG	Lipoic Acid plus Omega-3 Fatty Acids	alpha lipoic acid (racemic) and fish oil concentrate
DRUG	Placebo	placebo capsules

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-01-31
• Last updated: 2017-04-07
• Results posted: 2017-04-07

Locations

2 sites across 1 country: United States