Phase 2
N=42
Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
Treated Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01780974 ↗Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Apr 2017
Primary outcome: Primary: Trails Making Test Part B (Executive Function) — 69.57; 81.59; 62.53; 69.25 time to completion (seconds)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipoic Acid plus Omega-3 Fatty Acids (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trails Making Test Part B (Executive Function) |
69.57; 81.59; 62.53; 69.25; 69.75; 71.10 | — |
| SECONDARY White Matter Hyperintensity Volume (Brain MRI) |
6.13; 5.31; 5.14; 5.07 | — |
Summary
The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.
Eligibility Criteria
Inclusion Criteria
- 55 years or older
- Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
- Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
- Stable dose of antihypertensive medication 4 month prior to study enrollment
- Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
- Low Omega-3 fatty acid Status: Omega-3 index, once a week less than 4 months prior to enrollment
- Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver 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/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
- Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
- Enrollment in another treatment study
Data sourced from ClinicalTrials.gov (NCT01780974). 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.