Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension Alzheimer's Prevention Vascular Risk |
Drug: Lipoic Acid plus Omega-3 Fatty Acids |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention |
- Trails Making Test Part B (executive function) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]The primary outcome will be measured at 6 months and 12 months
- white matter hyperintensity volume (brain MRI) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Lipoic Acid plus Omega-3 Fatty Acids
alpha lipoic acid (racemic) and fish oil concentrate
Other Names:
|
| Experimental: Lipoic acid plus omega-3 fatty acids |
Drug: Lipoic Acid plus Omega-3 Fatty Acids
alpha lipoic acid (racemic) and fish oil concentrate
Other Names:
|
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| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 docsahexanoic 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| Contact: Courtney Zerizef, BS | 503-494-7240 | zerizefc@ohsu.edu |
| Contact: Lynne Shinto, ND, MPH | 503-494-5035 | shintol@ohsu.edu |
| United States, Oregon | |
| Lynne Shinto, ND, MPH | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: Lynne Shinto, ND, MPH | |
| Principal Investigator: | Lynne Shinto, ND, MPH | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Lynne Shinto, Associate Professor, Department of Neurology, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01780974 History of Changes |
| Other Study ID Numbers: | SFF01 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by 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 Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013