Trial Outcomes & Findings for Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness (NCT NCT01844726)
NCT ID: NCT01844726
Last Updated: 2023-04-20
Results Overview
Evidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
within 1 hour of administration
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
GLYX-13
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
GLYX-13
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Excessive motion in MRI resulted in discontinuation.
|
1
|
0
|
Baseline Characteristics
Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
Baseline characteristics by cohort
| Measure |
GLYX-13
n=21 Participants
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
n=21 Participants
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
25.2 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
26.2 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Estimated Intelligence Quotient (IQ)
|
105.7 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
107.9 units on a scale
STANDARD_DEVIATION 8.8 • n=7 Participants
|
106.8 units on a scale
STANDARD_DEVIATION 9.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: within 1 hour of administrationEvidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit.
Outcome measures
| Measure |
GLYX-13
n=21 Participants
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
n=21 Participants
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|---|---|---|
|
Percentage of Change in fMRI BOLD Signal During a Category Learning Task
|
.16 percentage of BOLD signal change
Standard Deviation .16
|
.08 percentage of BOLD signal change
Standard Deviation .15
|
SECONDARY outcome
Timeframe: within 1 hour of administrationThis measure reflects the percentage of correct trials on a category learning task in which subjects learned the category membership (group A or group B) of 8 three-digit numbers presented over 64 trials. Higher values (\>50%) reflect increased accuracy in learning the category membership.
Outcome measures
| Measure |
GLYX-13
n=21 Participants
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
n=21 Participants
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|---|---|---|
|
Category Learning Behavioral Performance
|
72.5 percentage of correct trials
Standard Deviation 16.4
|
75.2 percentage of correct trials
Standard Deviation 14.0
|
Adverse Events
GLYX-13
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLYX-13
n=21 participants at risk
Single IV infusion of GLYX-13, 5mg/kg,
GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
|
Placebo
n=21 participants at risk
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|---|---|---|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Fatigue
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Palpitation
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection discomfort
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place