Trial of Oxaloacetate in Alzheimer's Disease (TOAD)

Completed · Phase 1

Conditions studied: Alzheimer's Disease (AD)

In brief

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).

Key facts

Study ID

NCT02593318

Run by

Russell Swerdlow

People needed

32

Starts

2015-10-01

Expected to finish

2018-09-01

Last updated by the study team

2021-07-09

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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