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Trial record 2 of 3 for:    Lipoic Acid and Omega-3 Fatty Acids in Alzheimer’s Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01780974
First received: January 29, 2013
Last updated: June 5, 2014
Last verified: June 2014
  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
Treated Hypertension
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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 Study Completion Date: September 2015
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:
  • alpha lipoic acid
  • thiotic acid
  • fish oil concentrate
  • fish oil
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:
  • alpha lipoic acid
  • thiotic acid
  • fish oil concentrate
  • fish oil

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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780974

Contacts
Contact: Alena Borgatti, BA 503-494-7798 borgatti@ohsu.edu
Contact: Lynne Shinto, ND, MPH 503-494-5035 shintol@ohsu.edu

Locations
United States, Oregon
Lynne Shinto, ND, MPH Recruiting
Portland, Oregon, United States, 97239
Contact: Alena Borgatti, BA    503-494-7798    borgatti@ohsu.edu   
Contact: Lynne Shinto, ND, MPH    503-494-5035    shintol@ohsu.edu   
Principal Investigator: Lynne Shinto, ND, MPH         
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Alena Borgatti, BA    503-494-7798    borgatti@ohsu.edu   
Contact: Lynne Shinto, ND, MPH    503-494-5035    shintol@ohsu.edu   
Principal Investigator: Lynne Shinto, ND, MPH         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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: June 5, 2014
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:
Cardiovascular Diseases
Vascular Diseases
Thioctic Acid
Hypertension
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014