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

NCT01780974 | Completed Phase 1 Results DMC

• 1 other identifier: SFF01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Treated Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Trails Making Test Part B (Executive Function)

  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.

  Baseline, 6 months, and 12 months

Secondary Outcomes (1)

• White Matter Hyperintensity Volume (Brain MRI)

  Baseline and 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Lipoic acid plus omega-3 fatty acids

EXPERIMENTAL

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

Interventions

Lipoic Acid plus Omega-3 Fatty Acids DRUG

alpha lipoic acid (racemic) and fish oil concentrate

Also known as: alpha lipoic acid, thioctic acid, fish oil concentrate, fish oil

Lipoic acid plus omega-3 fatty acids

Placebo DRUG

placebo capsules

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Enrollment in another treatment study

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Lynne Shinto, ND, MPH

Portland, Oregon, 97239, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Thioctic Acid; Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Oils

Limitations and Caveats

No Omega-3 only or lipoic acid only arm; not excluding over-the-counter medications and supplements

Results Point of Contact

• Title: Lynne Shinto, ND, MPH
• Organization: Oregon Health & Science University

shintol@ohsu.edu

503-494-5035

Study Officials

• Lynne Shinto, ND, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Neurology

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Locations

US (2)