Back to resultsOxaloacetate Pharmacokinetics and Safety
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxaloacetate (OAA)
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring Oxaloacetate, OAA, AD, Alzheimer's Disease
Eligibility Criteria
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.)
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxaloacetate (OAA)
Arm Description
100 mg OAA to be taken twice daily over the course of a month
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02063308
Brief Title
Oxaloacetate Pharmacokinetics and Safety
Official Title
Oxaloacetate Pharmacokinetics and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Russell Swerdlow, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Oxaloacetate, OAA, AD, Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxaloacetate (OAA)
Arm Type
Experimental
Arm Description
100 mg OAA to be taken twice daily over the course of a month
Intervention Type
Dietary Supplement
Intervention Name(s)
Oxaloacetate (OAA)
Primary Outcome Measure Information:
Title
Correlation between oral OAA intake and plasma levels
Description
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.
Time Frame
Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing
Secondary Outcome Measure Information:
Title
safety of OAA in study participants
Description
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.
Time Frame
Change from Baseline to Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Swerdlow, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Oxaloacetate Pharmacokinetics and Safety
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