Trial of Oxaloacetate in Alzheimer's Disease (TOAD) (TOAD)
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|ClinicalTrials.gov Identifier: NCT02593318|
Recruitment Status : Completed
First Posted : November 1, 2015
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease (AD)||Drug: Oxaloacetate (OAA) 1g Drug: Oxaloacetate (OAA) 2g||Phase 1|
Alzheimer's disease (AD) is a progressive brain disorder that causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produce energy) might be linked to symptoms of AD. Some studies have shown that the brains in patients with Alzheimer's disease have reduced mitochondrial activity, have fewer mitochondria present in the nerve cells, and have reduced ability to utilize glucose (sugar) for energy.
Oxaloacetate (OAA) is a natural chemical that has been shown to have an effect on brain mitochondrial activity and brain energy in non-human animals.
This study is divided into two parts. In the first part of the study, researchers will test whether a dose of 1 gram per day of OAA, taken for approximately 4 weeks in 15 people with AD is safe and tolerable. After all 15 participants in part 1 have completed their participation, and it is determined that the study drug was safe at this dose, the second part of the study will begin. In part 2, researchers will test a dose of 2 grams per day of OAA, taken for approximately 4 weeks in 15 people with AD, to assess safety at this dose.
Participants will be in this study for about 10 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Oxaloacetate in Alzheimer's Disease (TOAD)|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Part 1 - Oxaloacetate (OAA) 1 gram/day
Participants take 1 gram of OAA per day for period of 4 weeks
Drug: Oxaloacetate (OAA) 1g
Pills to be taken orally in 500mg dose two times per day
Experimental: Part 2 - Oxaloacetate (OAA)2 gram/day
Participants take 2 grams of OAA per day for period of 4 weeks
Drug: Oxaloacetate (OAA) 2g
Pills to be taken orally in 1000mg dose two times per day.
- Number of Dose Limiting Toxicity Events [ Time Frame: Change from Baseline to Week 4 ]The number of dose limiting toxicity events will be determined by change in safety labs, physical and neurological exams, vital signs, cognitive measures, signs and symptoms.
- Change in Brain Glucose Metabolic Rate as Determined by Fluorodeoxyglucose Positron Emission Tomography (FDG PET) [ Time Frame: Change from Baseline to Week 4 ]Fluorodeoxyglucose positron emission tomography (FDG PET)
- Change in Brain Lactate Levels as Determined by Magnetic Resonance Spectroscopy (MRS) [ Time Frame: Change from Baseline to Week 4 ]magnetic resonance spectroscopy (MRS)
- Plasma Levels in 500 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose [ Time Frame: Change from dose to 60 min post dose and 90 min post dose ]For the 1 g/ day (500 mg bid) cohort, baseline blood sample will be obtained just before 500 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. The amount of OOA in the blood will be measured at each of the three time points.
- Plasma Levels in 1000 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose [ Time Frame: Change from dose to 60 min post dose and 90 min post dose ]For the 2 g/ day (1000 mg bid) cohort, baseline blood sample will be obtained before 1000 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. Plasma levels of OOA will be measured at each of the three timepoints.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593318
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Russell Swerdlow, MD||University of Kansas Medical Center|