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Trial of Oxaloacetate in Alzheimer's Disease (TOAD)

Completed

This study is designed to determine if oxaloacetate, a natural chemical that has been shown to have an effect on mitochondrial activity and energy in the brains of non-human animals, is safe and tolerable in people with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years Both No
October 2015
September 2018
30

  • Diagnosis of probable Alzheimer's disease
  • Clinical Dementia Rating score of 0.5 or 1 at last assessment; Mini-Mental Status Examination score of 15-28 at TOAD screening visit
  • Reliable, competent study partner who is willing to accompany participant to all study visits, monitor administration of study medication, and observe/report any changes in participant's health
  • On stable doses of other medications for at least 4 weeks prior to TOAD screening visit
  • English is primary spoken language
  • Women of child-bearing potential must have a negative urine pregnancy test at TOAD screening visit and agree to use of contraception throughout the trial

  • Dementia due to causes other than Alzheimer's disease
  • 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)
    • Recent cardiac event, such as heart attack or angioplasty, within 6 months prior to screening visit
    • Other conditions that pose potential safety risk or confounding factor
  • Any significant, abnormal clinical finding or laboratory test result found at screening visit
  • Any contraindication for magnetic resonance spectroscopy, such as presence of metal implants, cardiac pacemaker that is not compatible with MRS, or severe claustrophobia

Researchers believe mitochondria, the part of cells that produces energy, might be linked to symptoms of Alzheimer's disease. Some studies have shown that the brains of people with Alzheimer's disease have reduced mitochondrial activity, fewer mitochondria in the nerve cells, and reduced ability to utilize glucose (sugar) for energy. This clinical trial will test two doses of oxaloacetate in people with Alzheimer's to see if it is safe and look for changes in brain gluclose metabolism and other brain changes.

The study is divided into two parts. In the first part, 15 participants will take 1 gram per day of oxaloacetate for approximately 4 weeks. After it is determined that the study drug is safe at this dose, in part 2 researchers will test a 2-gram per day dose of of oxaloacetate, taken for approximately 4 weeks. All participants will be in this study for about 10 weeks and undergo brain imaging scans and blood tests.

Name City State Zip Status Primary Contact
University of Kansas Medical Center
Kansas City Kansas 66160

Russell Swerdlow, MD

Name Role Affiliation
Russell Swerdlow, MD Principal Investigator University of Kansas Medical Center

Name Phone Email
Becky Bothwell, MS 913-945-5033 rbothwell@kumc.edu
Paul Welch, MPH 913-945-6792 twelch@kumc.edu

NCT02593318

Trial of Oxaloacetate in Alzheimer's Disease (TOAD)