Trial Outcomes & Findings for A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (NCT NCT05104463)
NCT ID: NCT05104463
Last Updated: 2025-01-23
Results Overview
The number of participants experiencing treatment-emergent adverse events after receiving 3mg CST-2032 co-administered with 3mg CST-107 compared to placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Change from Baseline after 14 days of treatment
Results posted on
2025-01-23
Participant Flow
Participant milestones
| Measure |
CST-2032 (3mg)/CST-107 (3mg) to Placebo
Subjects will receive daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days, followed by a washout period of no drug for 7-21 days, followed by placebo for 14 days.
|
Placebo to CST-2032 (3mg)/CST-107 (3mg)
Subjects will receive placebo for 14 days followed by a washout period of no drug for 7-21 days, followed by daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
CST-2032 (3mg)/CST-107 (3mg) to Placebo
Subjects will receive daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days, followed by a washout period of no drug for 7-21 days, followed by placebo for 14 days.
|
Placebo to CST-2032 (3mg)/CST-107 (3mg)
Subjects will receive placebo for 14 days followed by a washout period of no drug for 7-21 days, followed by daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Overall
n=64 Participants
All participants enrolled in study
|
|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline after 14 days of treatmentPopulation: Safety Set - All participants who received at least 1 dose of blinded study drug.
The number of participants experiencing treatment-emergent adverse events after receiving 3mg CST-2032 co-administered with 3mg CST-107 compared to placebo
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=59 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events
|
19 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Change from Baseline after 14 days of treatment respectively (4 hours post dose)Population: Safety set - all participants who received at least 1 dose of study drug (CSR-2032, CST-107 or placebo). Participants were reported based on the treatment received. It is noted that whilst all the above participants were included in the overall analysis, there were some participants for whom data was not available at individual timepoints and the resulting corrected number of participants analyzed is presented per parameter below.
Change from Baseline in supine blood pressure (diastolic blood pressure and systolic blood pressure) after CST-2032 co-administered with CST-107 compared to placebo
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Vital Signs
Diastolic blood pressure - Supine Change from Baseline at Day 14
|
-0.6 mmHg
Standard Deviation 14.77
|
-1.6 mmHg
Standard Deviation 12.40
|
1.5 mmHg
Standard Deviation 8.21
|
2.4 mmHg
Standard Deviation 7.25
|
0.6 mmHg
Standard Deviation 11.55
|
0.6 mmHg
Standard Deviation 9.98
|
|
Vital Signs
Systolic blood pressure - Supine Change from Baseline at Day 14
|
-1.1 mmHg
Standard Deviation 22.17
|
-5.2 mmHg
Standard Deviation 19.24
|
1.3 mmHg
Standard Deviation 11.18
|
0.6 mmHg
Standard Deviation 9.53
|
0.2 mmHg
Standard Deviation 16.88
|
-2.0 mmHg
Standard Deviation 14.79
|
PRIMARY outcome
Timeframe: Change from Baseline after 14 days of treatment respectively (4 hour post-dose)Population: Safety set - all participants who received at least 1 dose of study drug (CST-2032, CST-107 or placebo). Participants were reported based on the treatment received.
Change from Baseline in QTc interval using the Fredericia (QTcF) corrections after treatment with CST-2032 co-administered with CST107 compared to placebo
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Electrocardiograms (ECGs)
|
4.402 msec
Standard Deviation 8.5028
|
4.532 msec
Standard Deviation 11.3533
|
2.771 msec
Standard Deviation 12.5605
|
3.411 msec
Standard Deviation 14.4734
|
3.515 msec
Standard Deviation 10.8381
|
3.909 msec
Standard Deviation 13.0718
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. It is noted that whilst all the above participants were included in the overall analysis, there were some participants for whom data was not available at individual timepoints and the resulting corrected number of participants analyzed is presented per parameter below.
Change from Baseline in Digit Symbol Substitution Test (DSST) after CST-2032 co-administered with CST-107 compared to placebo. Participants are asked to copy simple graphic symbols that are paired to the digits 1-9 within a specified time period. Using a key, the examinee is asked to draw each symbol under its corresponding number. The examinee's score is determined by the number of symbols correctly drawn within a 90-second time limit. Higher scores indicate better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DSST Score
Change from Baseline at Day 7
|
2.09 correct symbols
Standard Error 0.938
|
3.21 correct symbols
Standard Error 0.949
|
3.07 correct symbols
Standard Error 0.905
|
3.71 correct symbols
Standard Error 0.915
|
2.64 correct symbols
Standard Error 0.669
|
3.45 correct symbols
Standard Error 0.676
|
|
Change From Baseline in DSST Score
Change from Baseline at Day 14
|
2.79 correct symbols
Standard Error 0.938
|
2.57 correct symbols
Standard Error 0.949
|
2.95 correct symbols
Standard Error 0.906
|
4.71 correct symbols
Standard Error 0.915
|
2.88 correct symbols
Standard Error 0.669
|
3.71 correct symbols
Standard Error 0.676
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Partcipants were analyzed according to the treatment assigned at randomization.
Change from Baseline in Digit Symbol Substitution Test (DSST) after CST-2032 co-administered with CST-107 compared to placebo. Participants are asked to copy simple graphic symbols that are paired to the digits 1-9 within a specified time period. Using a key, the examinee is asked to draw each symbol under its corresponding number. The incorrect score is the number of symbols incorrectly drawn within a 90-second time limit. Lower scores indicate better performance; negative scores indicate better performance relative to baseline.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DSST Total Incorrect
Change from Baseline at Day 14
|
0.37 incorrect symbols
Standard Error 0.534
|
0.29 incorrect symbols
Standard Error 0.543
|
-0.89 incorrect symbols
Standard Error 0.476
|
-1.65 incorrect symbols
Standard Error 0.482
|
-0.30 incorrect symbols
Standard Error 0.359
|
-0.72 incorrect symbols
Standard Error 0.364
|
|
Change From Baseline in DSST Total Incorrect
Change from Baseline at Day 7
|
1.41 incorrect symbols
Standard Error 0.534
|
-0.03 incorrect symbols
Standard Error 0.543
|
-0.69 incorrect symbols
Standard Error 0.475
|
-1.55 incorrect symbols
Standard Error 0.482
|
0.28 incorrect symbols
Standard Error 0.359
|
-0.81 incorrect symbols
Standard Error 0.364
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization.
Measures response inhibition (impulse control). Participants must respond to an arrow stimulus by selecting one of two options, depending on the direction in which the arrow points. If an audio tone is present, subjects must withhold making that response (inhibition). Lower response times indicate better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CANTAB Stop Signal Reaction Time
Change from Baseline at Day 7
|
30.81 milliseconds
Standard Error 14.450
|
0.33 milliseconds
Standard Error 14.975
|
-22.27 milliseconds
Standard Error 14.824
|
-12.02 milliseconds
Standard Error 15.038
|
1.89 milliseconds
Standard Error 10.521
|
-6.39 milliseconds
Standard Error 10.756
|
|
Change From Baseline in CANTAB Stop Signal Reaction Time
Change from Baseline at Day 14
|
31.65 milliseconds
Standard Error 14.450
|
2.25 milliseconds
Standard Error 14.697
|
-34.68 milliseconds
Standard Error 14.838
|
-8.61 milliseconds
Standard Error 15.238
|
-4.70 milliseconds
Standard Error 10.524
|
-4.07 milliseconds
Standard Error 10.756
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization.
Measures changes in cognition by testing psychomotor speed (selecting a flashing circle on a touch tablet screen as quickly as possible). Lower response times indicate better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CANTAB 5-Choice Reaction Time
Change from Baseline at Day 7
|
1.56 milliseconds
Standard Error 16.120
|
-5.86 milliseconds
Standard Error 16.370
|
-29.53 milliseconds
Standard Error 9.762
|
-18.59 milliseconds
Standard Error 9.899
|
-14.21 milliseconds
Standard Error 9.529
|
-11.06 milliseconds
Standard Error 9.657
|
|
Change From Baseline in CANTAB 5-Choice Reaction Time
Change from Baseline at Day 14
|
0.38 milliseconds
Standard Error 16.120
|
15.74 milliseconds
Standard Error 16.370
|
-31.09 milliseconds
Standard Error 9.770
|
-40.83 milliseconds
Standard Error 10.024
|
-15.37 milliseconds
Standard Error 9.533
|
-13.21 milliseconds
Standard Error 9.719
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization.
Measures changes in cognition by testing attention (remembering the location of an abstract pattern on a touch tablet screen). Lower error scores indicate better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CANTAB Paired Associates Learning Tool - Total Adjusted Errors
Change from Baseline at Day 7
|
-4.46 incorrect patterns
Standard Error 2.517
|
-4.21 incorrect patterns
Standard Error 2.546
|
2.05 incorrect patterns
Standard Error 2.495
|
0.81 incorrect patterns
Standard Error 2.522
|
-1.28 incorrect patterns
Standard Error 1.785
|
-1.87 incorrect patterns
Standard Error 1.804
|
|
Change From Baseline in CANTAB Paired Associates Learning Tool - Total Adjusted Errors
Change from Baseline at Day 14
|
-0.11 incorrect patterns
Standard Error 2.517
|
-4.85 incorrect patterns
Standard Error 2.546
|
2.69 incorrect patterns
Standard Error 2.498
|
0.65 incorrect patterns
Standard Error 2.545
|
1.03 incorrect patterns
Standard Error 1.785
|
-2.22 incorrect patterns
Standard Error 1.813
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Subjects were analyzed according to the treatment assigned at randomization.
Measures changes in cognition by testing memory (recall of 18 words flashed onto a touch tablet screen). An increase in number of words recognized indicates better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CANTAB Delayed Verbal Recognition
Change from Baseline at Day 14
|
-1.08 words
Standard Error 0.637
|
0.47 words
Standard Error 0.637
|
0.30 words
Standard Error 0.745
|
-0.07 words
Standard Error 0.762
|
-0.25 words
Standard Error 0.506
|
0.21 words
Standard Error 0.512
|
|
Change From Baseline in CANTAB Delayed Verbal Recognition
Change from Baseline at Day 7
|
0.15 words
Standard Error 0.628
|
0.11 words
Standard Error 0.637
|
1.64 words
Standard Error 0.744
|
0.14 words
Standard Error 0.754
|
1.02 words
Standard Error 0.502
|
0.17 words
Standard Error 0.509
|
SECONDARY outcome
Timeframe: Change from Baseline after 7 and 14 days of treatment respectively.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study treatment (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization.
Measures changes in visual and motor coordination and vigilance. In this task, a small circle (target) continuously moves across the screen in a semi-randomized fashion, so as to minimize the subject's ability to predict the trajectory of the target. The subject is instructed to use his/her finger on the touch screen to move a small dot so that it is consistently within the center of the moving target on the screen. During the test, the speed of the circle is adjusted in response to the subject's ability to keep the dot in the circle, ensuring that the test is adapted to the individual subject. The outcome variable was the mean 'difficulty multiplier', which is a calculation adjustment of the participant's accuracy on target relative to current target speed, averaged over the entire testing session. The difficulty multiplier ranges from 0 to 10. Attainment of a higher difficulty multiplier indicates better performance.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CANTAB Adaptive Tracking Mean Level of Difficulty Achieved
Change from Baseline at Day 7
|
0.07 score on a scale
Standard Error 0.091
|
0.11 score on a scale
Standard Error 0.093
|
0.37 score on a scale
Standard Error 0.106
|
0.42 score on a scale
Standard Error 0.106
|
0.22 score on a scale
Standard Error 0.073
|
0.27 score on a scale
Standard Error 0.074
|
|
Change From Baseline in CANTAB Adaptive Tracking Mean Level of Difficulty Achieved
Change from Baseline at day 14
|
0.06 score on a scale
Standard Error 0.091
|
-0.06 score on a scale
Standard Error 0.093
|
0.36 score on a scale
Standard Error 0.106
|
0.34 score on a scale
Standard Error 0.107
|
0.21 score on a scale
Standard Error 0.073
|
0.15 score on a scale
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Change from Baseline after 14 days of treatment.Population: Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization.
Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Lower response times indicate better performance; negative response times indicate improvement from baseline
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=27 Participants
Participants following treatment with CST-2032 and CST-107.
|
AD Participants - Placebo
n=33 Participants
Participants with Alzheimer's disease, following treatment with placebo.
|
AD Participants - CST-2032/CST-107
n=32 Participants
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
|
Overall - Placebo
n=59 Participants
All participants following treatment with placebo.
|
Overall - CST-2032/CST-107
n=59 Participants
All participants following treatment with CST-2032/CST-107
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Reaction Time for Happy Expressions - Change from Baseline at Day 14
|
-178.52 milliseconds
Standard Error 69.13
|
-209.77 milliseconds
Standard Error 68.80
|
23.34 milliseconds
Standard Error 68.28
|
-89.75 milliseconds
Standard Error 68.97
|
-74.41 milliseconds
Standard Error 44.21
|
-145.62 milliseconds
Standard Error 44.40
|
|
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Reaction Time for Surprise Expressions - Change from Baseline at Day 14
|
-235.05 milliseconds
Standard Error 85.92
|
-186.53 milliseconds
Standard Error 85.89
|
16.26 milliseconds
Standard Error 64.96
|
-153.09 milliseconds
Standard Error 65.64
|
-96.45 milliseconds
Standard Error 50.70
|
-169.06 milliseconds
Standard Error 50.99
|
|
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Reaction Time for Negative Expressions - Change from Baseline at Day 14
|
-251.85 milliseconds
Standard Error 66.35
|
-222.02 milliseconds
Standard Error 66.35
|
-51.17 milliseconds
Standard Error 43.41
|
-76.53 milliseconds
Standard Error 43.86
|
-135.72 milliseconds
Standard Error 37.38
|
-149.30 milliseconds
Standard Error 37.42
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
CST-2032 and CST-107
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=59 participants at risk
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=59 participants at risk
Participants following treatment with CST-2032 and CST-107.
|
|---|---|---|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • Number of events 1 • From Day -1 to end of study (up to 48 days).
|
|
Hepatobiliary disorders
bile duct stone
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • Number of events 1 • From Day -1 to end of study (up to 48 days).
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • Number of events 1 • From Day -1 to end of study (up to 48 days).
|
|
Infections and infestations
postoperative wound infection
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • Number of events 1 • From Day -1 to end of study (up to 48 days).
|
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Participants following treatment with placebo.
|
CST-2032 and CST-107
n=59 participants at risk
Participants following treatment with CST-2032 and CST-107.
|
|---|---|---|
|
Investigations
Lipase increased
|
5.1%
3/59 • From Day -1 to end of study (up to 48 days).
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Amylase increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Blood sodium decreased
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Glucose urine
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Transaminases increased
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Blood alkaline phosphatase increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Blood creatine phosphokinase increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Blood potassium increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Protein urine
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Red blood cell count increased
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Urine leukocyte esterase positive
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Investigations
Bowel movement irregularity
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
|
Infections and infestations
Covid-19
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Dizziness
|
6.8%
4/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Tremor
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Dyskinesia
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
General disorders
Fatigue
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
3.4%
2/59 • From Day -1 to end of study (up to 48 days).
|
|
General disorders
Feeling abnormal
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
General disorders
Pain
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Cardiac disorders
Atrial fibrilation
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Abnormal dreams
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Agitation
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Middle insomnia
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Psychiatric disorders
Rapid eye movement sleep behaviour
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Surgical and medical procedures
Central nervous system stimulation
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of eyelid
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/59 • From Day -1 to end of study (up to 48 days).
|
1.7%
1/59 • From Day -1 to end of study (up to 48 days).
|
Additional Information
Clinical Trial Information Desk
CuraSen Therapeutics, Inc
Phone: +1 650 475 2842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER