Oxaloacetate Pharmacokinetics and Safety

Alzheimer's Disease Clinical Trial

Official title:

Oxaloacetate Pharmacokinetics and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063308
• Other study ID #: STUDY00000581
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: July 23, 2014
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Dietary Supplement:
• Oxaloacetate (OAA)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Russell Swerdlow, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between oral OAA intake and plasma levels	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.	Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing	No
Secondary	safety of OAA in study participants	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.	Change from Baseline to Month 1	Yes