Oxaloacetate Pharmacokinetics and Safety
Not Applicable
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Dietary Supplement: Oxaloacetate (OAA)
- Registration Number
- NCT02063308
- Lead Sponsor
- Russell Swerdlow, MD
- Brief Summary
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Meet criteria for Mild or Moderate AD
- Have a study partner
- Speak English as primary language.
Exclusion Criteria
- Absence of a study partner
- Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxaloacetate (OAA) Oxaloacetate (OAA) 100 mg OAA to be taken twice daily over the course of a month
- Primary Outcome Measures
Name Time Method Correlation between oral OAA intake and plasma levels Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration.
- Secondary Outcome Measures
Name Time Method safety of OAA in study participants Change from Baseline to Month 1 We will evaluate weights, blood counts, electrolytes, liver function tests, insulin levels, and plasma amino acid levels in subjects exposed to OAA for 1 month. These multiple measures will be used to generate a composite safety outcome measure.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States