Phase 2
Completed N=39
Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
Source: ClinicalTrials.gov NCT00090402 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Feb 2010
Primary outcomePrimary: F2-isoprostane Level Urine F2-Isoprostanes — 0.40; -2.02; 0.45 nanogram per miligram — p=0.83
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).
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 | — |
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
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. Informational only — not medical advice.