Phase 1
Completed N=32
Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Alzheimer's Disease (AD)
Source: ClinicalTrials.gov NCT02593318 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Dose Limiting Toxicity Events — 0; 0 Dose Limiting Toxicity Events
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dose Limiting Toxicity Events |
0; 0 | — |
| SECONDARY Change in Brain Glucose Metabolic Rate as Determined by Fluorodeoxyglucose Positron Emission Tomography (FDG PET) |
— | — |
| SECONDARY Change in Brain Lactate Levels as Determined by Magnetic Resonance Spectroscopy (MRS) |
— | — |
| SECONDARY Plasma Levels in 500 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose |
94; 63; 87 | — |
| SECONDARY Plasma Levels in 1000 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose |
1400; 1355; 1363 | — |
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
Data sourced from ClinicalTrials.gov (NCT02593318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.