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

Tracking Information
First Submitted Date ICMJE	January 27, 2010
First Posted Date ICMJE	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 ICMJE	September 2010
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE; (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 ]
Change History	Complete list of historical versions of study NCT01058941 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Alzheimer's Disease
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 1, 2017)	67
Original Estimated Enrollment ICMJE; (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 ICMJE	Inclusion 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. 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; 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 (for subjects enrolled at Bend, Medford, and Klamath sites that decide not to undergo MRI, this will not be an exclusion).; Enrollment in another study
Sex/Gender	Sexes Eligible for Study: All
Ages	55 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01058941
Other Study ID Numbers ICMJE	R01AG033613-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lynne Shinto, Oregon Health and Science University
Study Sponsor ICMJE	Oregon Health and Science University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
PRS Account	Oregon Health and Science University
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP