Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Intervention: Oxaloacetate (OAA) 1g; Oxaloacetate (OAA) 2g
Intervention description: Pills to be taken orally in 500mg dose two times per day; Pills to be taken orally in 1000mg dose two times per day.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: energy metabolism; oxaloacetate

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).
    

Eligibility criteria:

        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