Oxaloacetate Pharmacokinetics and Safety

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Oxaloacetate (OAA)

Dietary Supplement

Primary outcomes

Correlation between oral OAA intake and plasma levels

Time frame: 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 outcomes

safety of OAA in study participants

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Russell Swerdlow, MD

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 14, 2014
Registry last updated: Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed