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

NCT01058941 | Completed Phase 1 Results DMC

• 1 other identifier: R01AG033613-01A1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; fish oil; lipoic acid

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Activities of Daily Living (ADL) at 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.

  Baseline and 18 months

• Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 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.

  Baseline and 18 months

Study Arms (2)

Lipoic acid and Omega-3 fatty acids

EXPERIMENTAL

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.

Drug: Lipoic acid and fish oil concentrate

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Lipoic acid and fish oil concentrate DRUG

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

Also known as: alpha lipoic acid, thiotic acid, fish oil, omega-3 fatty acids

Lipoic acid and Omega-3 fatty acids

Placebo DRUG

Placebo LA and placebo oil capsules for 18 months

Also known as: Placebo for lipoic acid and fish oil concentrate

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-AD dementia
• 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. 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.
• 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
• Enrollment in another study

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Thioctic Acid; Fish Oils; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Oils; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated

Results Point of Contact

• Title: Dr. Lynne Shinto, ND, MPH
• Organization: Oregon Health & Science University

shintol@ohsu.edu

503-494-5035

Study Officials

• Lynne Shinto, ND, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lynne Shinto, ND, MPH

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 29, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (1)