Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 29, 2013
June 5, 2014
April 2013
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01780974 on ClinicalTrials.gov Archive Site
white matter hyperintensity volume (brain MRI) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Treated Hypertension
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
  • Placebo Comparator: Placebo
    Intervention: Drug: Lipoic Acid plus Omega-3 Fatty Acids
  • Experimental: Lipoic acid plus omega-3 fatty acids
    Intervention: Drug: Lipoic Acid plus Omega-3 Fatty Acids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact: Alena Borgatti, BA 503-494-7798 borgatti@ohsu.edu
Contact: Lynne Shinto, ND, MPH 503-494-5035 shintol@ohsu.edu
United States
 
NCT01780974
SFF01
Yes
Lynne Shinto, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
Oregon Health and Science University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP