Trial Outcomes & Findings for Trial of Oxaloacetate in Alzheimer's Disease (TOAD) (NCT NCT02593318)
NCT ID: NCT02593318
Last Updated: 2021-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Change from Baseline to Week 4
Results posted on
2021-07-09
Participant Flow
Original plan was to enroll 30 participants. After enrolling 30 participants, two enrolled participants were withdrawn from the study after assignment to groups but did not complete post treatment data collection. Therefore those two were replaced so that total number of participants who completed post treatment data was 30, increasing the total number of enrolled participants to 32.
Participant milestones
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
n=15 Participants
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
n=15 Participants
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 5.7 • n=15 Participants
|
71.3 years
STANDARD_DEVIATION 8.1 • n=15 Participants
|
70.7 years
STANDARD_DEVIATION 6.9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
10 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Baseline MMSE
|
21.5 Scores on a Scale
STANDARD_DEVIATION 4.3 • n=15 Participants
|
21.9 Scores on a Scale
STANDARD_DEVIATION 3.2 • n=15 Participants
|
21.7 Scores on a Scale
STANDARD_DEVIATION 3.8 • n=30 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 4The 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.
Outcome measures
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
n=15 Participants
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
n=15 Participants
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 90 Minutes Post Administration of Dose
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn 90 minutes post administration of dose.
|
|---|---|---|---|
|
Number of Dose Limiting Toxicity Events
|
0 Dose Limiting Toxicity Events
|
0 Dose Limiting Toxicity Events
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 4Fluorodeoxyglucose positron emission tomography (FDG PET)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 4magnetic resonance spectroscopy (MRS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from dose to 60 min post dose and 90 min post doseFor 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.
Outcome measures
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
n=15 Participants
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
n=15 Participants
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 90 Minutes Post Administration of Dose
n=15 Participants
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn 90 minutes post administration of dose.
|
|---|---|---|---|
|
Plasma Levels in 500 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose
|
94 ng/mL
Standard Deviation 102
|
63 ng/mL
Standard Deviation 55
|
87 ng/mL
Standard Deviation 80
|
SECONDARY outcome
Timeframe: Change from dose to 60 min post dose and 90 min post doseFor 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.
Outcome measures
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
n=15 Participants
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
n=15 Participants
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 90 Minutes Post Administration of Dose
n=15 Participants
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn 90 minutes post administration of dose.
|
|---|---|---|---|
|
Plasma Levels in 1000 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose
|
1400 ng/mL
Standard Deviation 962
|
1355 ng/mL
Standard Deviation 690
|
1363 ng/mL
Standard Deviation 759
|
Adverse Events
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 - Oxaloacetate (OAA)2 Gram/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 - Oxaloacetate (OAA) 1 Gram/Day
n=15 participants at risk
Participants take 1 gram of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
Part 2 - Oxaloacetate (OAA)2 Gram/Day
n=15 participants at risk
Participants take 2 grams of OAA per day for period of 4 weeks
Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study
|
|---|---|---|
|
Nervous system disorders
Increased confusion
|
13.3%
2/15 • Number of events 2 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Nervous system disorders
Cervical Stenosis
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
General disorders
Syncope
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 8 weeks
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/15 • 8 weeks
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
|
Reproductive system and breast disorders
Breast calcification
|
0.00%
0/15 • 8 weeks
|
6.7%
1/15 • Number of events 1 • 8 weeks
|
Additional Information
Russell H. Swerdlow, MD
University of Kansas Medical Center
Phone: 9135885000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place