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

• ClinicalTrials.gov Identifier: NCT01780974
• Recruitment Status: Completed
• First Posted: January 31, 2013
• Results First Posted: April 7, 2017
• Last Update Posted: April 7, 2017
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Lynne Shinto, Oregon Health and Science University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Treated Hypertension	Drug: Lipoic Acid plus Omega-3 Fatty Acids; Drug: Placebo	Phase 1; Phase 2

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.	Drug: Lipoic Acid plus Omega-3 Fatty Acids; alpha lipoic acid (racemic) and fish oil concentrate; Other Names: alpha lipoic acid; thioctic acid; fish oil concentrate; fish oil

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. White Matter Hyperintensity Volume (Brain MRI) [ Time Frame: Baseline and 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oregon

Lynne Shinto, ND, MPH

Portland, Oregon, United States, 97239

Oregon Health & Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

• Principal Investigator: Lynne Shinto, ND, MPH; Oregon Health and Science University

More Information

• 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
• 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

Keywords provided by Lynne Shinto, Oregon Health and Science University:

Hypertension; Vascular Risk; Alzheimer's Risk; fish oil; Lipoic acid

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Thioctic Acid; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients