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Trial record 1 of 28 for:    oxaloacetate
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Trial of Oxaloacetate in Alzheimer's Disease (TOAD) (TOAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02593318
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Russell Swerdlow, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE November 1, 2015
Last Update Posted Date October 12, 2018
Study Start Date  ICMJE October 2015
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
Change in Safety Assessments (safety labs, physical and neurological exams, vital signs, cognitive measures, signs and symptoms) [ Time Frame: Change from Baseline to Week 4 ]
Change in safety labs, physical and neurological exams, vital signs, cognitive measures, signs and symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Change in brain glucose metabolic rate as determined by Fluorodeoxyglucose positron emission tomography (FDG PET) [ Time Frame: Change from Baseline to Week 4 ]
    Fluorodeoxyglucose positron emission tomography (FDG PET)
  • Change in brain lactate levels as determined by magnetic resonance spectroscopy (MRS) [ Time Frame: Change from Baseline to Week 4 ]
    magnetic resonance spectroscopy (MRS)
  • Correlation between oral OAA intake and plasma levels in 500 mg bid cohort [ Time Frame: Change from dose to 60 min post dose and 90 min post dose ]
    For the 1 g/ day (500 mg bid) cohort, baseline blood sample will be obtained before 500 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose.
  • Correlation between oral OAA intake and plasma levels in 1000 mg bid cohort [ Time Frame: Change from dose to 60 min post dose and 90 min post dose ]
    For the 2 g/ day (1000 mg bid) cohort, baseline blood sample will be obtained before 1000 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Official Title  ICMJE Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Brief Summary The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at doses of up to 2 grams per day in people with Alzheimer's disease (AD).
Detailed Description

Alzheimer's disease (AD) is a progressive brain disorder that causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produce energy) might be linked to symptoms of AD. Some studies have shown that the brains in patients with Alzheimer's disease have reduced mitochondrial activity, have fewer mitochondria present in the nerve cells, and have reduced ability to utilize glucose (sugar) for energy.

Oxaloacetate (OAA) is a natural chemical that has been shown to have an effect on brain mitochondrial activity and brain energy in non-human animals.

This study is divided into two parts. In the first part of the study, researchers will test whether a dose of 1 gram per day of OAA, taken for approximately 4 weeks in 15 people with AD is safe and tolerable. After all 15 participants in part 1 have completed their participation, and it is determined that the study drug was safe at this dose, the second part of the study will begin. In part 2, researchers will test a dose of 2 grams per day of OAA, taken for approximately 4 weeks in 15 people with AD, to assess safety at this dose.

Participants will be in this study for about 10 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease (AD)
Intervention  ICMJE Drug: Oxaloacetate (OAA)
Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
Other Names:
  • Oxobutanedioic acid
  • Oxaloacetic acid
  • Oxalacetic acid
  • 2-Oxosuccinic acid
  • Ketosuccinic acid
Study Arms  ICMJE
  • Experimental: Part 1 - Oxaloacetate (OAA) 1 gram/day
    Participants take 1 gram of OAA per day for period of 4 weeks
    Intervention: Drug: Oxaloacetate (OAA)
  • Experimental: Part 2 - Oxaloacetate (OAA)2 gram/day
    Participants take 2 grams of OAA per day for period of 4 weeks
    Intervention: Drug: Oxaloacetate (OAA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of probable Alzheimer's disease (AD) per McKhann et al. criteria [9];
  • Have a clinical dementia rating (CDR) score of 0.5 or 1 at time of their last University of Kansas Alzheimer's Disease Center (KU ADC) assessment;
  • Have a Mini Mental Status Exam (MMSE) score of 15-28 at the TOAD screening visit;
  • Have a reliable and competent study partner who is willing to accompany the participant to all study visits, monitor compliance of study medication administration, and observe/report any changes in the participant's health throughout the study duration;
  • Are on stable doses of concurrent medications for at least 4 weeks prior to the TOAD screening visit; and
  • Speaks English as his/her primary language.
  • If female of child-bearing potential, must have a negative urine pregnancy test at TOAD screening visit (and must agree to use of contraception throughout the trial)

Exclusion Criteria:

  • Dementia due to causes other than AD;
  • Potentially confounding, serious, or unstable medical conditions such as:

    • insulin-dependent diabetes mellitus
    • cancer within the past 3 years (except basal cell, squamous cell, or localized prostate cancer)
    • a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 6 months prior to screening visit)
    • other conditions that pose a potential safety risk or confounding factor in the investigator's opinion;
  • Any abnormal physical examination assessment or vital sign assessment at TOAD screening visit that is deemed to be clinically significant by the principal investigator;
  • Any abnormal clinical laboratory test result at TOAD screening visit that is deemed to be clinically significant by the principal investigator.
  • Any contraindication for undergoing magnetic resonance spectroscopy (MRS), such as the presence of metal implants, a cardiac pacemaker that is not compatible with MRS, or severe claustrophobia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593318
Other Study ID Numbers  ICMJE STUDY00002242
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Russell Swerdlow, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Russell Swerdlow, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Russell Swerdlow, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP