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Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01058941
First received: January 27, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to see if taking lipoic acid plus omega-3 fatty acids (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow the AD process, the investigators will look at changes in memory and changes in a person's daily activities over 18 months.


Condition Intervention Phase
Alzheimer's Disease
Drug: lipoic acid and fish oil concentrate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Activities of Daily Living and Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 1) Baseline and 6 months 2) Baseline and 12 months 3) Baseline and 18 months ] [ Designated as safety issue: No ]
    The two primary outcome measures will be measured as 6 months, 12 months, and 18 months and compared to baseline measures.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lipoic acid and omega-3 fatty acids
lipoic acid and fish oil concentrate
Drug: lipoic acid and fish oil concentrate
lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
Other Names:
  • alpha lipoic acid
  • thiotic acid
  • fish oil
  • omega-3 fatty acids
Placebo Comparator: Placebo
placebo lipoic acid plus placebo oil
Drug: lipoic acid and fish oil concentrate
lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
Other Names:
  • alpha lipoic acid
  • thiotic acid
  • fish oil
  • omega-3 fatty acids

Detailed Description:

Current pharmacological agents for AD have had no impact on disease prevalence and have had limited effects on improving the clinical course of AD. The exponential rise in the prevalence, incidence, and cost of care for AD make finding therapeutic agents that can either prevent AD or delay disease progression an urgent health care need. Since inflammation, lipid dysregulation, and insulin resistance have each been associated with AD pathology, the combination of lipoic acid plus fish oil has the potential to maximize therapeutic benefit by acting on all three mechanisms associated with disease pathology. Our primary study aim is to evaluate the ability of lipoic acid plus omega-3 fatty acids to delay cognitive and functional decline in people with AD. The investigators will also evaluate the effect of lipoic acid plus omega-3 fatty acids on changes in serum and plasma biomarkers over 18 months to determine which markers are associated with whole brain atrophy (MRI volume changes) and clinical outcomes (ADAS-cog, ADL). The associations identified will aid in the identification of specific biomarkers that may be used to evaluate treatment effects in future clinical trials.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • 55 years or older
  • Probable AD by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association - NINCDS/ADRDA criteria
  • MMSE between 15-26
  • Caregiver/study partner that can accompany participant to all study visits
  • Stable use of cholinesterase inhibitors and memantine permitted - doses must be stable for 4 months prior to study enrollment
  • Stable doses of over-the-counter antioxidants (e.g. vitamin E, ginkgo biloba) are permitted - dose must be stable for 4 months prior to study enrollment
  • Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
  • Geriatric Depression Scale (GDS) - Score of < 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:

  • Non-AD dementia
  • Residence in nursing home facility at screening visit (residence in community assisted living and long-term care facilities in which the participant still performs majority of basic activities of daily living will not be an exclusion)
  • History of clinically significant stroke (stroke with neurologic deficits > 6 months after diagnosis)
  • 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)
  • Hyperlipidemic (triglycerides >500 mg/dl, LDL > 160 mg/dl, total cholesterol >240 mg/dl). LDL levels between 160 mg/dl and 165 mg/dl will be reviewed by the PI and included if judged to be safe.
  • 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, or flaxseed 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 narcotic analgesics. Certain low dose antipsychotic use will be reviewed by the principle investigator on a case-by-case basis and may be allowed if determined that dose is not strong enough to affect performance on cognitive evaluations. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
  • Contraindications to MRI.
  • Enrollment in another 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: NCT01058941

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
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, Lynne Shinto, ND, MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01058941     History of Changes
Other Study ID Numbers: R01AG033613-01A1
Study First Received: January 27, 2010
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Alzheimer's disease
fish oil
lipoic acid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
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 September 18, 2014