- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780974
Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
February 22, 2017 updated by: Lynne Shinto, Oregon Health and Science University
Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Portland, Oregon, United States, 97239
- Lynne Shinto, ND, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
alpha lipoic acid (racemic) and fish oil concentrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
White Matter Hyperintensity Volume (Brain MRI)
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
January 29, 2013
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFF01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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