Trial Outcomes & Findings for Nicotinic Receptors and Schizophrenia (NCT NCT01400477)
NCT ID: NCT01400477
Last Updated: 2019-05-07
Results Overview
MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
DMXB-A-SR
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
|
Arm #2: Placebo Comparator
Inert capsule to resemble active drug.
Placebo: Placebo Comparator
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotinic Receptors and Schizophrenia
Baseline characteristics by cohort
| Measure |
DMXB-A-SR
n=40 Participants
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
|
Arm #2: Placebo Comparator
n=40 Participants
Inert capsule to resemble active drug.
Placebo: Placebo Comparator
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
43.2 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
44.8 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: participants
MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.
Outcome measures
| Measure |
DMXB-A-SR
n=38 Participants
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
|
Arm #2: Placebo Comparator
n=40 Participants
Inert capsule to resemble active drug.
Placebo: Placebo Comparator
|
|---|---|---|
|
Neurocognitive Efficacy
|
0.6 MATRICS Neurocognitive T score
Standard Deviation 5.8
|
2.1 MATRICS Neurocognitive T score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Participants
The P50 evoked response paired of auditory stimuli S1, S2, is measured. The inhibition is expressed as the ratio P50 S2 amplitude divided by P50 S1 amplitude.
Outcome measures
| Measure |
DMXB-A-SR
n=38 Participants
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
DMXB-A-SR: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
|
Arm #2: Placebo Comparator
n=40 Participants
Inert capsule to resemble active drug.
Placebo: Placebo Comparator
|
|---|---|---|
|
Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli
|
0.57 percentage of amplitude
Standard Deviation 0.12
|
0.52 percentage of amplitude
Standard Deviation 0.14
|
Adverse Events
DMXB-A-SR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm #2: Placebo Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place