Oxaloacetate Pharmacokinetics and Safety

N/ACompletedNCT02063308

Russell Swerdlow, MD6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

Oxaloacetate (OAA)DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing

Secondary Outcomes

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.

Time frame: Change from Baseline to Month 1

Data from ClinicalTrials.gov

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