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

• ClinicalTrials.gov Identifier: NCT01058941
• Recruitment Status: Completed
• First Posted: January 29, 2010
• Results First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Lynne Shinto, Oregon Health and Science University

Tracking Information

• First Submitted Date: January 27, 2010
• First Posted Date: January 29, 2010
• Results First Submitted Date: March 1, 2017
• Results First Posted Date: April 13, 2017
• Last Update Posted Date: April 13, 2017
• Study Start Date: September 2010
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2017)

• Change From Baseline in Activities of Daily Living (ADL) at 18 Months [ Time Frame: Baseline and 18 months ]
  The Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) is used to assess activities of daily living in people with AD using a structured interview to ask the AD participant's caregiver/study partner to assess functional ability over a wide range of performance measures. A higher ADL score indicates greater impairment in functional ability; scores range from 0 to 27.
• Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months [ Time Frame: Baseline and 18 months ]
  The ADAS-cog assesses general cognitive function over multiple domains and evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates greater impairment on a range of scores from 0 to 70. A total score of 70 indicates maximum severity.

• Original Primary Outcome Measures (submitted: January 28, 2010): Activities of Daily Living and Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: baseline, 6 months, 12 months, 18 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
• Official Title: Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer's Disease

Intervention

• Drug: Lipoic acid and fish oil concentrate
  Lipoic 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
• Drug: Placebo
  Placebo LA and placebo oil capsules for 18 months
  Other Name: Placebo for lipoic acid and fish oil concentrate

Study Arms

• Experimental: 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.
  Intervention: Drug: Lipoic acid and fish oil concentrate
• Placebo Comparator: 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.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2017): 67
• Original Estimated Enrollment (submitted: January 28, 2010): 100
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01058941
• Other Study ID Numbers: R01AG033613-01A1( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lynne Shinto, Oregon Health and Science University
• Original Responsible Party: Deborah Golden-Eppelein, Lynne Shinto
• Current Study Sponsor: Oregon Health and Science University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lynne Shinto, ND, MPH; Oregon Health and Science University

• PRS Account: Oregon Health and Science University
• Verification Date: March 2017