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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01058941
• Other study ID #: R01AG033613-01A1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 27, 2010
• Last updated: May 7, 2014
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: May 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• lipoic acid and fish oil concentrate
lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activities of Daily Living and Alzheimer's Disease Assessment Scale - cognitive subscale	The two primary outcome measures will be measured as 6 months, 12 months, and 18 months and compared to baseline measures.	1) Baseline and 6 months 2) Baseline and 12 months 3) Baseline and 18 months	No