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

NCT ID: NCT01058941

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study was 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 looked at changes in memory and changes in a person's daily activities over 18 months.

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lipoic acid and Omega-3 fatty acids

Three 1-gram fish oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two lipoic acid (LA) capsules per day in the morning. Total daily dose of study drug: 675 mg DHA, 975 mg EPA, 600 mg LA.

Group Type: EXPERIMENTAL

Lipoic acid and fish oil concentrate

Intervention Type: DRUG

Lipoic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Placebo

Three placebo oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two placebo LA capsules per day in the morning.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo LA and placebo oil capsules for 18 months

Interventions

Lipoic acid and fish oil concentrate

Lipoic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Intervention Type: DRUG

Placebo

Placebo LA and placebo oil capsules for 18 months

Intervention Type: DRUG

Other Intervention Names

alpha lipoic acid; thiotic acid; fish oil; omega-3 fatty acids; Placebo for lipoic acid and fish oil concentrate

Eligibility Criteria

Inclusion Criteria

1. 55 years or older

2. Probable AD by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association - NINCDS/ADRDA criteria

3. MMSE between 15-26

4. Caregiver/study partner that can accompany participant to all study visits

5. Stable use of cholinesterase inhibitors and memantine permitted - doses must be stable for 4 months prior to study enrollment

6. 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

7. Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment

8. Geriatric Depression Scale (GDS) - Score of < 5

9. General health status that will not interfere with the participant's ability to complete the study.

10. Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator

11. Sufficient English language skills to complete all testing

Exclusion Criteria

1. Non-AD dementia

2. 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)

3. History of clinically significant stroke (stroke with neurologic deficits > 6 months after diagnosis)

4. 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)

5. Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)

6. 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. Patients who have a history or hyperlipidemia, but are not taking lipid-lowering medications due to potential memory impairment side effects will be reviewed on a case-by-case basis by the PI and enrolled in the study if deemed safe by PI and the patient's primary care provider.

7. Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment

8. Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 4 months prior to enrollment

9. Lipoic Acid supplementation less than 1 month prior to enrollment

10. 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.

11. Contraindications to MRI (for subjects enrolled at Bend, Medford, and Klamath sites that decide not to undergo MRI, this will not be an exclusion).

12. Enrollment in another study

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lynne Shinto

Lynne Shinto, ND, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynne Shinto, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

R01AG033613-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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