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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

January 27, 2010
May 7, 2014
September 2010
January 2015   (final data collection date for primary outcome measure)
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.
Activities of Daily Living and Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01058941 on ClinicalTrials.gov Archive Site
Not Provided
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Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
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
  • Experimental: lipoic acid and omega-3 fatty acids
    lipoic acid and fish oil concentrate
    Intervention: Drug: lipoic acid and fish oil concentrate
  • Placebo Comparator: Placebo
    placebo lipoic acid plus placebo oil
    Intervention: Drug: lipoic acid and fish oil concentrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058941
R01AG033613-01A1
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
May 2014

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