NCT02063308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

February 12, 2014

Last Update Submit

July 23, 2014

Conditions

Alzheimer's Disease

Keywords

OxaloacetateOAAADAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • safety of OAA in study participants

    Change from Baseline to Month 1

Study Arms (1)

Oxaloacetate (OAA)

EXPERIMENTAL

100 mg OAA to be taken twice daily over the course of a month

Dietary Supplement: Oxaloacetate (OAA)

Interventions

Oxaloacetate (OAA)DIETARY_SUPPLEMENT
Oxaloacetate (OAA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet criteria for Mild or Moderate AD
  • Have a study partner
  • Speak English as primary language.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Oxaloacetic Acid

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OxaloacetatesOxalatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsKeto Acids

Study Officials

  • Russell Swerdlow, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gene and Marge Sweeney Professor of Neurology

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

US(1)