Trial of Oxaloacetate in Alzheimer's Disease (TOAD)

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Russell Swerdlow; Russell Swerdlow, MD

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