Trial record 3 of 4 for:    alpha-lipoic acid alzheimer's

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

This study is currently recruiting participants.
Verified November 2013 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: November 20, 2013
Last verified: November 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780974

Contacts
Contact: Andy Fraser, BS 503-494-7240 fraseam@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: Andy Fraser, BS    503-494-7240    frasean@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: Andy Fraser, BS    503-494-7240    frasean@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: November 20, 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:
Thioctic Acid
Hypertension
Vascular Diseases
Cardiovascular Diseases
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 April 21, 2014