Phase 2 N=39 Randomized Triple-blind Treatment

Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease

Alzheimer's Disease · Oxidative Stress · Dementia · Hyperlipidemia · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT00090402 ↗

Enrolled (actual)

Serious AEs

5.1%

Results posted

Feb 2010

Primary outcome: Primary: F2-isoprostane Level Urine F2-Isoprostanes — 0.40; -2.02; 0.45 nanogram per miligram — p=0.83

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fish Oil (Dietary_supplement); Lipoic Acid (Dietary_supplement); Fish Oil Placebo (Other); Lipoic Acid Placebo (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Jan 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY F2-isoprostane Level Urine F2-Isoprostanes	0.40; -2.02; 0.45	0.83
PRIMARY Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months	-4.64; -4.27; -1.00	—
SECONDARY Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months	4.2; 0.7; 0.9	—

Summary

The purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of Alzheimer's Disease (AD).

Eligibility Criteria

Inclusion Criteria

Diagnosis of probable Alzheimer's Disease or mild cognitive impairment
Mini Mental State Examination (MMSE) score between 18 and 26
Clinical Dementia Rating (CDR) of 0.5 or 1.0
Fluent in English

Exclusion Criteria

Use of lipid lowering medications
Consumption of fish of more than twice a week
Use of omega and alpha lipoic acid supplements
Use of systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, or narcotic analgesics
Depression
Any other serious health conditions that may interfere with the study
Enrollment in another clinical trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.